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Vol. 144, No. 40 — October 2, 2010

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after Screening Assessment of Substances — Batch 6

CAS No. 85-86-9
CAS No. 6358-57-2
CAS No. 19800-42-1
CAS No. 7147-42-4

Publication after Screening Assessment of a Substance — Batch 8

CAS No. 65140-91-2

Publication after Screening Assessment of Substances — Batch 11

CAS No. 103-23-1
CAS No. 68412-48-6
CAS No. 68478-45-5
CAS No. 68953-84-4
CAS No. 98-01-1
CAS No. 140-88-5
CAS No. 149-57-5
CAS No. 68952-02-3
CAS No. 70900-21-9
CAS No. 603-33-8
CAS No. 10448-09-6
CAS No. 40615-36-9
CAS No. 64111-81-5
CAS No. 69430-47-3
CAS No. 125328-28-1

Publication of Results of Investigations and Recommendations for a Substance

CAS No. 107-22-2

Publication after screening assessment of a substance1-[[4-(phenylazo)phenyl]azo]- 2-Naphthalenol (Solvent Red 23), CAS No. 85-86-9 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 1-[[4-(phenylazo)phenyl]azo]- 2-Naphthalenol is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby;

Whereas it is proposed to conclude that the substance meets one or more of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to recommend to Her Excellency the Governor in Council that the substance be added to Schedule 1 of the Act.

Notice is furthermore given that the Ministers of the Environment and of Health have released a risk management scope document for this substance to initiate discussions with stakeholders on the development of a proposed risk management approach document.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of
1-[[4-(phenylazo)phenyl]azo]- 2-Naphthalenol

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of 1-[[4-(phenylazo)phenyl]azo]- 2-Naphthalenol, (herein referred to as Solvent Red 23), Chemical Abstracts Service Registry No. 8586-9. This substance was identified as a high priority for screening assessment and included in the Challenge because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance Solvent Red 23 was not considered to be a high priority for assessment of potential risks to human health, based on the application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List.

Solvent Red 23 is an organic substance that is used in Canada primarily in oils, fats and waxes, but also in alcohol-based, ester and hydrocarbon solvents, in polystyrene, in cosmetics and as an indicator. It is also used as a pesticide colourant and has been known to be used as a textile dye. It is not naturally produced in the environment. Solvent Red 23 is not reported to be manufactured in Canada. In 2006, Solvent Red 23 was not reported to be imported or used in Canada. However, four companies reported importing between 100 and 1 000 kg of the substance into the country in 2005 in products in response to a Canadian survey conducted under section 71 of CEPA 1999.

Based on reported use patterns in Canada related to personal care products, it is anticipated that 100% of products containing Solvent Red 23 could be released to sewer, surface water or land during their use. Sewer water is the medium potentially receiving the greatest proportion of Solvent Red 23 during product use. It is anticipated that the majority of Solvent Red 23, bound to sewage sludge from down-the-drain releases of cosmetics and personal care products to sewage treatment plants (STPs), will be sent entrained in sludge to landfills. In addition to being found in landfills, some of the biosolids from wastewater treatment facilities may be applied to forested or agricultural land and a small percentage may be incinerated.

Solvent Red 23 is not expected to be soluble in water or to be volatile, but is expected to adsorb to particles because of its hydrophobic nature. For these reasons and because it is heavier than water, after release to water, Solvent Red 23 will likely be found in sediments and, possibly to a much lesser extent, in agricultural soil that has been amended with sewage sludge. Solvent Red 23 is not expected to be significantly present in other media and is not expected to be subject to long-range atmospheric transport.

Based on the physical and chemical properties of Solvent Red 23, it is expected to be persistent in soil, sediment, and water. However, new experimental data relating to the bioaccumulation potential of a relatively close structural analogue suggests that this dye has a low potential to accumulate in the lipid tissues of organisms. This substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for chemical analogues suggest that Solvent Red 23 does not cause acute harm to aquatic organisms exposed at low concentrations.

For this draft screening assessment, a conservative exposure scenario was selected in which a single wastewater treatment plant was assumed to discharge all the maximum quantity range of Solvent Red 23 based on the most recent survey. Additionally, since Solvent Red 23 may be used in consumer products, a conservative consumer release scenario was developed based on an estimate of the quantity of this dye in Canadian commerce. The predicted environmental concentration in water was below the predicted no-effect concentration calculated for sensitive aquatic species.

Based on the information available, it is proposed to conclude that Solvent Red 23 is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

Exposure of the general population to Solvent Red 23 from environmental media is expected to be negligible. However, exposure can occur through the use of cosmetics and personal care products containing Solvent Red 23. Empirical health effects data for Solvent Red 23 are limited. Solvent Red 23 is a member of a class of substances characterized by the presence of one or more azo (-N=N-) groups, which can be subject to azo reductive cleavage resulting in the release of aromatic amines. In particular, azo reductive cleavage of Solvent Red 23 may result in the release of 4-aminoazobenzene, a substance that has been classified by the International Agency for Research on Cancer (IARC) and the European Commission on the basis of its carcinogenicity. Solvent Red 23 is also structurally similar to another azo dye that has been demonstrated to induce liver neoplasias in orally exposed male and female rats in a dose dependent manner and is classified as a mutagen and carcinogen by the European Commission. Based on consideration of the potential for exposure to the general population from use of cosmetics and personal care products containing Solvent Red 23, and on evidence of potential genotoxicity and carcinogenicity for which there may be a probability of harm at any level of exposure, Solvent Red 23 is proposed to be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Where relevant, research and monitoring will support verification of assumptions used during the screening assessment and, where appropriate, the performance of potential control measures identified during the risk management phase.

Proposed conclusion

Based on the information available, it is proposed to conclude that 1-[[4-(phenylazo)phenyl]azo]- 2-Naphthalenol meets one or more of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment as well as the risk management scope document for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance2,7-Naphthalenedisulfonic acid, 3-[[2,2′-dimethyl-4′-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-4-hydroxy-, disodium salt (Acid Red 111), CAS No. 6358-57-2 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 2,7-Naphthalenedisulfonic acid, 3-[[2,2′-dimethyl4′-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-4-hydroxy-, disodium salt is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby;

Whereas it is proposed to conclude that the substance does not meet any of the criteria set out in section 64 of the Act; and

Whereas the Minister of the Environment intends to amend the Domestic Substances List, under subsection 87(3) of the Act, to indicate that subsection 81(3) thereof applies with respect to this substance,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on the substance at this time under section 77 of the Act.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 2,7-Naphthalenedisulfonic acid, 3-[[2,2′-dimethyl-4′-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl]azo][1,1′-biphenyl]-4-yl] azo]-4-hydroxy-, disodium salt

Pursuant to section 74 of the Canadian Environmental Protection Act,1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of 2,7-Naphthalenedisulfonic acid, 3-[[2,2′-dimethyl-4′-[[4[[(4-methylphenyl)sulfonyl]oxy]phenyl]azo][1,1′-biphenyl]-4-yl] azo]-4-hydroxy-, disodium salt (herein referred to as Acid Red 111), Chemical Abstracts Service Registry No. 6358-57-2. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada. Acid Red 111 was not considered to be a high priority for assessment of potential risks to human health, based on the application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List.

Acid Red 111 is a synthetic dye that is used as a colourant primarily in the textile industry. Applications of this substance include paper, leather, plastics, inks and paints. This substance does not naturally occur in the environment. As a result of industry surveys conducted pursuant to section 71 of CEPA 1999, companies reported a combined total import of 100–1 000 kg of this substance into Canada above the reporting thresholds in both 2005 and 2006.

Based on reported use patterns and certain assumptions related to dyes in general, releases of Acid Red 111 to the Canadian environment during the formulation and consumer use of products containing this substance are estimated to be 15% to wastewater and 85% transferred to waste disposal sites (landfill and incineration). Acid Red 111 is an azo dye with two sulfonic acid groups, which dictate its adsorption characteristics and impart high water solubility. Dyes have an inherently high affinity to substrates, and a potentially large proportion can be removed during wastewater treatment as a result of such substances being adsorbed to biosolids.

Information on other disulfonated acid dyes, as well as results of QSAR modelling, suggests that Acid Red 111 is expected to persist in aerobic environments (i.e. water, soil, sediment). Degradation of Acid Red 111 under anaerobic or reducing conditions may occur relatively rapidly, but would be limited to specific environments (e.g. deep layers of sediments), with potentially harmful metabolites being formed as a result of cleavage of its azo bonds. However, in these situations exposure to aquatic organisms would be limited. The high water solubility of this substance, as well as other physical and chemical properties (e.g. large molecular size), suggests that it has a low potential to accumulate in the lipid tissues of organisms. Therefore, Acid Red 111 meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for Acid Red 111 and other disulfonated acid dyes suggest that this substance is not expected to cause acute harm to aquatic organisms at low concentrations.

For this draft screening assessment, a conservative exposure scenario was selected in which an industrial operation discharges this substance into the aquatic environment through a single wastewater treatment plant. The upper end of the reporting range of 1 000 kg was used to conservatively estimate release and exposure levels. The predicted environmental concentration in water of this substance (0.03 mg/L) was below the predicted no-effect concentration for sensitive aquatic organisms (> 0.1 mg/L), resulting in a risk quotient of much lower than one.

Based on the ecological information available, it is proposed to conclude that Acid Red 111 is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

The potential for exposure of the general population to Acid Red 111 from environmental media is expected to be negligible. Exposure to Acid Red 111 from consumer products (e.g. fabrics, textiles, personal apparel), is expected to be negligible as Acid Red 111 is predominantly used as a colourant in textiles that are not frequently used by the general population. Empirical data pertaining to the health effects of Acid Red 111 were limited. However, information from analogues of Acid Red 111, and from potential azo cleavage products indicates that there may be concern for genotoxicity and carcinogenicity. Although the potential high hazard of Acid Red 111 is recognized, on the basis of information which indicates that general population exposure is expected to be negligible due to the nature of its use and application, risk to human health is considered to be low.

Because Acid Red 111 is listed on the Domestic Substances List, its import and manufacture in Canada are not subject to notification under subsection 81(1). Given the potential health hazards of this substance, there is concern that new activities that have not been identified or assessed could lead to this substance meeting the criteria set out in section 64 of the Act. Therefore, it is recommended to amend the Domestic Substance List, under subsection 87(3) of the Act, to indicate that subsection 81(3) of the Act applies with respect to this substance so that new manufacture, import or use of this substance be subject to notification and undergo ecological and human health risk assessments.

Proposed conclusion

Based on the information available, it is proposed to conclude that 2,7-Naphthalenedisulfonic acid, 3-[[2,2′-dimethyl-4′-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-4-hydroxy-, disodium salt does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substancePhenol, 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]- (Disperse Orange 29), CAS No. 19800-42-1 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Phenol, 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl] azo]- is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that the substance does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on the substance at this time under section 77 of the Act.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Phenol, 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Phenol, 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]- (herein referred to as Disperse Orange 29), Chemical Abstracts Service Registry No. 19800-42-1. This substance was identified as a high priority for screening assessment and included in the Challenge because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance Disperse Orange 29 was not considered to be a high priority for assessment of potential risks to human health, based on the application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List.

Disperse Orange 29 is an organic substance that is used in Canada primarily as a textile dye. It is not naturally produced in the environment. Disperse Orange 29 was not reported to be manufactured in Canada in 2006 or 2005; however, in 2006, one company reported importing 2 000 kg of the substance into the country. In 2005, two companies reported importing Disperse Orange 29 into Canada. Based on information provided by industry in response to a survey conducted under section 71 of CEPA 1999, one company imported between 100 and 1 000 kg and another company imported between 1 001 and 100 000 kg, either in products or for use in the manufacturing of various coloured products.

Based on reported use patterns in Canada and certain assumptions, it is expected that the majority of the quantity of Disperse Orange 29 which is used in Canada ultimately is deposited in waste disposal sites. A significant amount would, however, be estimated to be released to sewer water (14.8%). Disperse Orange 29 is not expected to be soluble in water or to be volatile, but is expected to adsorb on particles because of its hydrophobic nature. For these reasons and because it is heavier than water, after release to water, Disperse Orange 29 will likely be found in sediments and, possibly to a much lesser extent, in agricultural soil that has been amended with sewage sludge. Disperse Orange 29 is not expected to be significantly present in other media and is not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, Disperse Orange 29 is expected to be persistent in soil, sediment, and water. However, new experimental data relating to the bioaccumulation potential of a relatively close structural analogue suggests that this dye has a low potential to accumulate in the lipid tissues of organisms. This substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for chemical analogues suggest that Disperse Orange 29 does not cause acute harm to aquatic organisms exposed at low concentrations.

For this draft screening assessment, a conservative exposure scenario was selected in which a single wastewater treatment plant was assumed to discharge the maximum quantity of Disperse Orange 29 based on the most recent survey. Additionally, since Disperse Orange 29 may be used in consumer products, a conservative consumer release scenario was developed based on an estimate of the quantity of this dye in Canadian commerce. The predicted environmental concentration in water was below the predicted no-effect concentration calculated for sensitive aquatic species.

Based on the information available, it is proposed to conclude that Disperse Orange 29 is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

Exposure of the general population to Disperse Orange 29 from environmental media is expected to be negligible. The general population may be exposed to Disperse Orange 29 from its use as a dye in textiles and fabrics; however, dermal and oral exposure is expected to be low. No empirical health effects data were available for Disperse Orange 29 or for suitable analogues. Although the potential hazard of Disperse Orange 29 due to possible formation of component aromatic amines from azo cleavage is recognized, taking into consideration the expected low exposure to the general population, the potential risk to human health is considered to be low at current levels. It is proposed to conclude that Disperse Orange 29 is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Proposed conclusion

Based on the information available, it is proposed to conclude that Phenol, 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]- does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substanceButanamide, 2,2′-[(3,3′-dimethoxy[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxo-(BPAOPB), CAS No. 7147-42-4 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Butanamide, 2,2′-[(3,3′-dimethoxy[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxo- is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that the substance does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on the substance at this time under section 77 of the Act.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Butanamide, 2,2′-[(3,3′-dimethoxy[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxo-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Butanamide, 2,2′-[(3,3′-dimethoxy[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxo- (BPAOPB), Chemical Abstracts Service Registry No. 7147-42-4.

This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada. The substance BPAOPB was not considered to be a high priority for assessment of potential risks to human health, based on the application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List.

The substance BPAOPB is a disazo diarylide organic pigment that exists as a powder. Such pigments are used primarily as colour pigments in printing inks and plastics, and to a lesser extent in coatings. This substance does not naturally occur in the environment. As a result of industry surveys conducted pursuant to section 71 of CEPA 1999, total manufacturing of BPAOPB was reported between 100 and 1 000 kg in Canada in 2006, while no imports or uses were reported for that year.

Based on reported use patterns and certain assumptions, releases of BPAOPB to the Canadian environment resulting from its manufacture are estimated to be less than 1% to air and 4% to wastewater. It is estimated that 2% is transferred to waste disposal sites. There are no experimental data available on the physical and chemical properties of this substance. Given the data available for other pigments identified as suitable analogues, BPAOPB is believed to be present in the environment as a chemically stable, non-volatile, solid particle that has very low water solubility. As a result, it would be found in sediments if released to surface waters and would tend to remain in soils if released to terrestrial environments.

Modelled data suggest that little degradation of this substance would occur in aerobic environments (i.e. water, sediment, soil). Model-generated bioaccumulation estimates that are based on experimental data for the solubility in octanol and water of pigments identified as analogues, as well as the fact that BPAOPB is a very large molecule, suggest that this pigment has a low potential to accumulate in the lipid tissues of organisms. Therefore, BPAOPB is persistent but not bioaccumulative in accordance with criteria set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for other pigments identified as analogues suggest that saturated solutions of the substance do not cause acute harm to aquatic organisms.

For this draft screening assessment, a conservative exposure scenario was selected in which an industrial operation discharges BPAOPB into the aquatic environment through a single waste water treatment plant. The upper end of the reporting range of 1 000 kg per year was used to conservatively estimate release and exposure levels. The predicted environmental concentration in water for this substance (0.009 mg/L) was below the predicted no-effect concentration for sensitive aquatic organisms (0.76 mg/L), resulting in a risk quotient of much lower than one.

Based on the ecological information available, it is proposed to conclude that BPAOPB is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

Exposure of the general population to BPAOPB from environmental media is considered to be negligible. Exposures from use of consumer products were not identified. No empirical health effects data were available for BPAOPB. Based on metabolism information and information on health effects of analogues, the hazard potential of BPAOPB is expected to be low. Based on the low hazard potential of BPAOPB and expected negligible exposure of the general population, the potential risks to human health for this substance are considered to be low. It is proposed to conclude that BPAOPB is not a substance entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Proposed conclusion

Based on the information available, it is proposed to conclude that Butanamide, 2,2′-[(3,3′-dimethoxy[1,1′-biphenyl]-4,4′-diyl) bis(azo)]bis[N-(2-methylphenyl)-3-oxo- does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substancePhosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, monoethyl ester, calcium salt (2:1), CAS No. 65140-91-2— specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Phosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, monoethyl ester, calcium salt (2:1) is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas new information was received in the form of public comments in response to the publication of an earlier draft Screening Assessment conducted on this substance and released for public comment on January 30, 2010;

Whereas a summary of a revised draft Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that the substance does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on the substance at this time under section 77 of the Act.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Phosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, monoethyl ester, calcium salt (2:1)

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Phosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, monoethyl ester, calcium salt (2:1), hereinafter referred to as PADMEC, Chemical Abstracts Service Registry No. 65140-91-2. This substance was identified as a high priority for screening assessment and included in the Challenge because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and was believed to be in commerce in Canada.

The substance PADMEC was not considered to be a high priority for assessment of potential risks to human health, based on the application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

The substance PADMEC is an organic substance that is used as an antioxidant/stabilizer in plastics, synthetic fibres, elastomers, adhesives, waxes, oils and fats, to protect against thermo-oxidative degradation. The substance is not naturally produced in the environment. Between 1 000 and 100 000 kg of PADMEC were imported into Canada in 2005, and even though none was reportedly in commerce in Canada in 2006, one company has indicated to the Government of Canada that they are considering importing PADMEC in the future. This information indicates that releases of this substance into the Canadian environment could be expected.

Based on expected usage patterns and certain assumptions, most of the substance would end up in waste disposal sites. A small proportion would be released to water through wastewater (0.8%) and a smaller proportion to soil through landfills and sewage sludge. No releases to air would be expected. The anionic form of PADMEC that exists at ambient pH range is very soluble in water, is not volatile and does not have a tendency to partition to particles and lipids (fat) of organisms. Therefore, PADMEC would likely be found mainly in water, and to a lesser extent in soils.

The substance PADMEC is not expected to degrade quickly in the environmental media where it may be released. It is, therefore, considered persistent in water and soil. New experimental and modelled data relating to its partitioning between octanol and water suggest that it has a low potential to accumulate in the lipid tissues of organisms. The substance has been determined to meet the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, new experimental toxicity data suggest that PADMEC has low toxicity to aquatic organisms.

A very conservative exposure scenario was prepared in which the upper end of the range for quantities of PADMEC imported into Canada in 2005 (100 000 kg) was assumed to be used at a single industrial site, with discharge into the aquatic environment. The predicted environmental concentration in water (PEC) was below the predicted no-effect concentration (PNEC) calculated for sensitive aquatic species.

Empirical health effects data were not identified for PADMEC. Based on health effects data for an analogue, a high hazard potential has not been identified for PADMEC. As PADMEC is not currently imported or manufactured in Canada at levels above the reporting threshold, the likelihood of exposure to the general population in Canada is considered to be low. Therefore, it is proposed to conclude that PADMEC is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on human life and health.

Based on the information available, it is proposed to conclude that PADMEC is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

This substance will be considered for inclusion in the Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that Phosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, monoethyl ester, calcium salt (2:1) does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication of results of investigations and recommendations for a substance Ethanedial, CAS No. 107-22-2 — specified on the Domestic Substance List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Whereas ethanedial is a substance identified as high priority for action under the Challenge, published in the Canada Gazette, Part I, on December 9, 2006;

Whereas the summary of the draft Screening Assessment conducted on the substance pursuant to paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999 is annexed hereby; and

Whereas it is proposed to conclude that the substance does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on the substance at this time.

Public comment period

Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment of Ethanedial

The Ministers of the Environment and of Health have conducted a screening assessment of ethanedial, Chemical Abstracts Service Registry No. 107-22-2. The substance ethanedial was identified in the categorization of the Domestic Substance List as a high priority for action under the Challenge. Ethanedial was identified as a high priority as it was considered to pose intermediate potential for exposure of individuals in Canada and is classified by other agencies on the basis of genotoxicity. This substance did not meet the ecological categorization criteria for persistence, bioaccumulation or inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of ethanedial relates principally to evaluation of risks to human health.

Ethanedial can occur naturally. It is also used in Canada in corrosion inhibitors and anti-scaling agents, as a finishing agent in textiles, paper and leather, as an intermediate in reactions to produce other substances for commercial use, as a processing aid for petroleum production, as a viscosity adjustor, as a paint and coating additive, and in pest control products. According to information reported under section 71 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), between 100 and 1 000 kg of ethanedial was manufactured in Canada in 2006. In addition, Canadian companies reported importing over 135 000 kg and using just under 242 000 kg in that year. Between 10 000 and 100 000 kg of ethanedial was released into the environment in 2006, with the highest release to wastewater.

Based on available information on concentrations of ethanedial in the environment (water, soil and air) and food, as well as on data submitted under section 71 of CEPA 1999, the general population is expected to be exposed to ethanedial primarily from environmental media (ambient and indoor air) and from its naturally occurring presence in food. Additionally, the general population may be exposed to low levels of ethanedial resulting from its presence as a residual in certain consumer products, such as paint and face wash, and from its use as a finishing agent in paper.

As ethanedial was classified on the basis of genotoxicity by the European Union, genotoxicity was a key focus for this screening assessment. Ethanedial tested positive in a range of in vitro assays for mutagenicity and genotoxicity. However, the results of in vivo tests indicated that genotoxicity occurred predominantly at the site of entry and in the liver, but not in distant tissues, when administered orally. Carcinogenicity was not observed when ethanedial was administered dermally to mice for their lifespan (cancer bioassays by oral and inhalation routes have not been conducted). Based on the existence of protective mechanisms, it is expected that intracellular ethanedial concentrations must overcome a threshold before genotoxicity occurs. Therefore, a threshold approach is used to characterize risk to human health.

Non-cancer effects were observed in repeated-dose studies. Decreased body and organ weight, and decreased food intake, were the most consistently observed effects in rats exposed to the substance by the oral route in repeated-dose studies. Exposure by inhalation to ethanedial aerosols induced minimal squamous metaplasia of the rat epiglottal epithelium, while acute exposures to ethanedial vapour saturated atmospheres caused an increased breathing rate in rats. Repeated dermal exposures resulted in irritation and necrotic areas on the skin of some exposed mice. The margins between upper-bounding estimates of exposure and the critical effect levels are considered to be adequate to address uncertainties in health effects and exposure databases. It is proposed to conclude that ethanedial is not a substance that is entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Based on its physical and chemical properties, it is expected that if released to air, the substance partitions to soil and water, and that if released to soil or water, the substance will mostly remain in these compartments. Based on these considerations and the use pattern of ethanedial, the substance will mainly be found in water.

Based on empirical biodegradation studies, ethanedial is not expected to be persistent in the environment. It is also expected to have very low bioaccumulation potential based on modelled data. Ethanedial therefore does not meet the persistence or bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. It was also found to have low acute toxicity to aquatic organisms.

For the evaluation of ecological risk, conservative exposure scenarios were examined in which the six largest users/importers of ethanedial in Canada discharge ethanedial into the aquatic environment. The predicted environmental concentrations in water at these sites were all below the predicted no-effect concentrations calculated for algae, which was the most sensitive aquatic species.

Based on the information available, it is proposed to conclude that ethanedial is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

This substance will be considered for inclusion in the Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that ethanedial does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substanceHexanedioic acid, bis(2-ethylhexyl) ester,CAS No. 103-23-1 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Hexanedioic acid, bis(2-ethylhexyl) ester is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Hexanedioic acid, bis(2-ethylhexyl) ester meets one or more of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to recommend to Her Ex- cellency the Governor in Council that Hexanedioic acid, bis(2-ethylhexyl) ester be added to Schedule 1 of the Act.

Notice is furthermore given that the Ministers of the Environment and of Health have released a risk management scope document for this substance to initiate discussions with stakeholders on the development of a proposed risk management approach document.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Hexanedioic acid, bis(2-ethylhexyl) ester

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Hexanedioic acid, bis(2-ethylhexyl) ester (DEHA), Chemical Abstracts Service Registry No. 103-23-1. The substance DEHA was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge as it was determined to present “greatest potential for exposure” of individuals in Canada and was considered to present a high hazard to human health, based on the classification by other agencies on the basis of carcinogenicity. Although originally the substance did not meet the ecological categorization criteria for persistence, bioaccumulation or inherent toxicity to aquatic organisms, the assessment determined DEHA to be toxic to aquatic organisms.

According to information reported under section 71 of CEPA 1999, DEHA was manufactured in Canada in 2006 at quantities between 1 and 10 million kilograms. Approximately 250 000 kg of DEHA were imported into Canada above the reporting threshold of 100 kg in the same reporting year. The majority of information submitted under section 71 of CEPA 1999 indicated that DEHA is used as a plasticizer. Globally, this substance is primarily used as a plasticizer in the flexible vinyl industry and may be used in flexible polyvinylchloride (PVC) food packaging (cling film). Sources of exposure of the general population of Canada are expected to be environmental media, food (as a result of migration from food packaging), and consumer products containing DEHA in Canada (including cosmetics and personal care products, auto interior protectants, heavy-duty hand cleansers, and lubricants).

As DEHA was classified with regards to its potential carcinogenicity by international agencies, this health effect was examined in this screening assessment. Increased liver tumours were observed in female mice, occurring at mid and high doses, but not in rats. The proposed mode of tumour induction is not considered to operate in humans, and the observed tumours are therefore considered to be of limited relevance to human health risk characterization. Additionally, while the mode of induction has not been fully elucidated, consideration of the available information on genotoxicity indicates that DEHA is not likely to be genotoxic. Accordingly, a threshold approach is used to characterize risk to human health.

The critical effect for characterization of risk to human health for DEHA is developmental toxicity (increased postnatal deaths observed in rats). Based on a comparison of estimated exposures to DEHA in Canada to the critical effect levels for developmental effects, and taking into account the uncertainties in the databases on exposure and effects, it is considered that the margins of exposure resulting from use of certain cosmetics and personal care products are potentially inadequate. Based on the available information, it is proposed to conclude that DEHA is entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

The low water solubility of DEHA, as well as its tendency to partition to particles and lipids (fat) of organisms, indicates that it will predominantly reside in soil and sediment when released to the environment. Despite its tendency to partition to lipids, DEHA appears to have a low bioaccumulation potential, likely due to rapid metabolism. Both empirical and modelled data demonstrate that DEHA biodegrades fast in water, and it is also not expected to persist in air, sediment, or soil. Acute toxicity studies generally report no effects to aquatic organisms at the water solubility limit, but there is potential for chronic toxicity, particularly for invertebrates.

For this screening assessment, realistic estimates of exposure were determined for site-specific industrial release and consumer release to water. A comparison of these predicted environmental concentrations (as well as actual concentrations measured in Canadian river water and effluents) with the predicted no-effect concentration suggests that harm to aquatic organisms is possible at many of the sites.

On the basis of ecological hazard and estimated releases of DEHA, it is proposed to conclude that this substance is entering or may be entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. The substance DEHA does not meet the criteria for persistence or bioaccumulation as set out in the Persistence and Bioaccumulation Regulations.

This substance will be considered for inclusion in the Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment and, where appropriate, the performance of potential control measures identified during the risk management phase.

Proposed conclusion

Based on the information available, it is proposed to conclude that Hexanedioic acid, bis(2-ethylhexyl) ester meets one or more of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment as well as the risk management scope document for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — 2-Propanone, reaction products with diphenylamine, CAS No. 68412-48-6 —specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 2-Propanone, reaction products with diphenylamine is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby;

Whereas it is proposed to conclude that 2-Propanone, reaction products with diphenylamine meets one or more of the criteria set out in section 64 of the Act; and

Whereas the Ministers are satisfied that the criteria set out under subsection 77(4) of the Act are met,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to recommend to Her Excellency the Governor in Council that 2-Propanone, reaction products with diphenylamine be added to Schedule 1 of the Act.

Notice therefore is further given that the Ministers of the Environment and of Health propose the implementation of virtual elimination of 2-Propanone, reaction products with diphenylamine under subsection 65(3) of the Act.

Notice is furthermore given that the Ministers of the Environment and of Health have released a risk management scope document for this substance to initiate discussions with stakeholders on the development of a proposed risk management approach document.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measures the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 2-Propanone,
Reaction Products With Diphenylamine

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of 2-Propanone, reaction products with diphenylamine (PREPOD), Chemical Abstracts Service Registry No. 68412-48-6. This substance was identified as a high priority for a screening assessment and included in the Challenge because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance PREPOD was not considered to be a high priority for assessment of potential risks to human health, based on the application of the simple exposure and hazard tools developed for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

The substance PREPOD is an organic UVCB (Unknown or Variable Composition, Complex Reaction Products or Biological Materials) substance that is used in Canada and elsewhere as a plasticizer for automotive applications, and as an antioxidant in rubber and plastics manufacturing. The substance is not naturally produced in the environment. Between 100 and 1 000 kg of PREPOD were imported into Canada in 2006. Between 100 000 and 1 000 000 kg of PREPOD were manufactured and used in Canada in 2006. The quantity of PREPOD manufactured and used in Canada indicates that high quantities could be released into the Canadian environment.

Based on reported use patterns and certain assumptions, most of the substance ends up in waste disposal sites. Small proportions are estimated to be released to wastewater (7.1%) and air by incineration (0.1%). PREPOD is not very soluble in water, is not volatile and has a tendency to partition to particles and lipids (fat) of organisms because of its hydrophobic nature. For these reasons, PREPOD will likely be found mostly in soil and sediments. It is not expected to be significantly present in other media.

Based on its physical and chemical properties, PREPOD is not expected to degrade quickly in the environment. It is, therefore, persistent in water, soil and sediments. PREPOD is also expected to have the potential to accumulate in organisms and may biomagnify in trophic food chains. The substance has thus been determined to meet the criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, modelled acute aquatic toxicity data indicate that the substance is potentially highly hazardous to aquatic organisms.

Given that long-term risks associated with persistent and bioaccumulative substances cannot at present be reliably predicted, quantitative risk estimates have limited relevance. Furthermore, since accumulations of such substances may be widespread and are difficult to reverse, a conservative response to uncertainty is justified.

Based on the information available, it is proposed to conclude that PREPOD is entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity.

Exposure of the general population to PREPOD through environmental media (air, drinking water and soil) and food and beverages is expected to be low. General population exposure to PREPOD from use of consumer products is not expected.

Empirical health effects information for PREPOD is limited. Quantitative structure activity relationship (QSAR) model predictions for carcinogenicity, genotoxicity, and reproductive and developmental toxicity for PREPOD were mixed. Limited studies on analogues did not indicate genotoxicity and were used to identify critical non-cancer effect levels. Based on the information available, the margin of exposure between the upper-bounding estimate of exposure via environmental media for PREPOD and the level of an analogue associated with effects in experimental animals is considered to be adequate to address uncertainties in the health effects and exposure databases.

Based on the information presented in this draft screening assessment, it is proposed to conclude that PREPOD is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

This substance will be considered for inclusion in the Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment and, where appropriate, the performance of potential control measures identified during the risk management phase.

Proposed conclusion

Based on the information available, it is proposed to conclude that 2-Propanone, reaction products with diphenylamine meets one or more of the criteria set out in section 64 of CEPA 1999.

In addition, it is proposed to conclude that 2-Propanone, reaction products with diphenylamine meets the criteria for persistence and bioaccumulation potential as out in the Persistence and Bioaccumulation Regulations and its presence in the environment results primarily from human activity.

The draft Screening Assessment as well as the risk management scope document for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of two substances 1,4-Benzenediamine, N,N′-mixed tolyl and xylyl derivs., CAS No. 68478-45-5; and 1,4-Benzenediamine, N,N′-mixed Ph and tolyl derivs., CAS No. 68953-84-4— specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 1,4-Benzenediamine, N,N′-mixed tolyl and xylyl derivs. and 1,4-Benzenediamine, N,N′-mixed Ph and tolyl derivs. are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on the substances pursuant to section 74 of the Act is annexed hereby;

Whereas it is proposed to conclude that 1,4-Benzenediamine, N,N′-mixed tolyl and xylyl derivs. and 1,4-Benzenediamine, N,N′-mixed Ph and tolyl derivs. meet one or more of the criteria set out in section 64 of the Act; and

Whereas the Ministers are satisfied that the criteria set out under subsection 77(4) of the Act are met,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to recommend to Her Excellency the Governor in Council that 1,4-Benzenediamine, N,N′-mixed tolyl and xylyl derivs. and 1,4-Benzenediamine, N,N′-mixed Ph and tolyl derivs. be added to Schedule 1 of the Act.

Notice therefore is further given that the Ministers of the Environment and of Health propose the implementation of virtual elimination of 1,4-Benzenediamine, N,N′-mixed tolyl and xylyl derivs. and 1,4-Benzenediamine, N,N′-mixed Ph and tolyl derivs. under subsection 65(3) of the Act.

Notice is furthermore given that the Ministers of the Environment and of Health have released a risk management scope document for these substances to initiate discussions with stakeholders on the development of a proposed risk management approach document.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measures the Ministers propose to take and on the scientific considerations on the basis of which the measures are proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 1,4-Benzenediamine, N,N′-mixed tolyl and xylyl derivs. and 1,4-Benzenediamine, N,N′-mixed Ph and tolyl derivs.

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of 1,4-Benzenediamine, N,N′-mixed Phenyl and tolyl derivatives (BENPAT), Chemical Abstracts Service Registry No. 68953-84-4, and 1,4-Benzenediamine, N,N′-mixed tolyl and xylyl derivatives (BENTAX), Chemical Abstracts Service Registry No. 68478-45-5.

These substances were identified as a high priority for screening assessment and included in the Challenge because they were found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and are believed to be in commerce in Canada.

These substances were not considered to be a high priority for assessment of potential risks to human health, based on the application of the simple exposure and hazard tools developed for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses principally on information relevant to the evaluation of ecological risks.

The substances BENPAT and BENTAX are classified as UVCBs (Unknown or Variable Composition, Complex Reaction Products, or Biological Materials), and they are used in Canada and elsewhere in rubber product manufacturing. BENPAT and BENTAX function as antidegradents (antiozonants and antioxidants) in rubber products. These substances are not naturally produced in the environment. Between 100 and 1 000 kg of BENTAX and between 1 000 000 and 10 000 000 kg of BENPAT were imported into Canada in 2006. The quantities of BENPAT and BENTAX imported into Canada, along with the potentially dispersive uses of these substances, indicate that they could be released into the Canadian environment.

Based on experimental degradation data as well as their physical and chemical properties, both BENPAT and BENTAX are not expected to degrade quickly in the environment. They are persistent in water, soil and sediments. BENPAT and BENTAX also have the potential to accumulate in organisms and may biomagnify in trophic food chains. These substances have been determined to meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity values indicate that these substances are highly hazardous to aquatic organisms.

Given that long-term risks associated with persistent and bioaccumulative substances cannot at present be reliably predicted, quantitative risk estimates have limited relevance. Furthermore, since accumulations of such substances may be widespread and are difficult to reverse, a conservative response to uncertainty is justified.

Based on the information available, it is proposed to conclude that BENPAT and BENTAX are entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity.

Chronic studies for BENPAT and an analogue indicated no evidence of carcinogenicity in experimental animals and available information on genotoxicity indicates that BENPAT and BENTAX are not likely to be genotoxic. As general population exposure to BENTAX was considered to be negligible, the risk to human health was considered to be low. Margins of exposure between upper-bounding estimates of exposure to BENPAT via environmental media and critical effects levels in experimental animals are considered to be adequate to address uncertainties in the health effects and exposure databases.

Based on the information presented in this draft screening assessment, it is proposed to conclude that BENTAX and BENPAT are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

These substances will be considered for inclusion in the Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment and, where appropriate, the performance of potential control measures identified during the risk management phase.

Proposed conclusion

Based on the information available, it is proposed to conclude that 1,4-Benzenediamine, N,N′-mixed tolyl and xylyl derivs. and 1,4-Benzenediamine, N,N′-mixed Ph and tolyl derivs. meet one or more of the criteria set out in section 64 of CEPA 1999.

In addition, it is proposed to conclude that 1,4-Benzenediamine, N,N′-mixed tolyl and xylyl derivs. and 1,4-Benzenediamine, N,N′-mixed Ph and tolyl derivs. meet the criteria for persistence and bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations and their presence in the environment results primarily from human activity.

The draft Screening Assessment as well as the risk management scope document for these substances is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance2-Furancarboxaldehyde, CAS No. 98-01-1 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 2-Furancarboxaldehyde is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that the substance does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on the substance at this time under section 77 of the Act.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 2-Furancarboxaldehyde

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of 2-Furancarboxaldehyde, also known as furfural, Chemical Abstracts Service Registry No. 98-01-1. This substance was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. Furfural was identified as a high priority as it was determined to present a “greatest potential for exposure” of individuals in Canada and had been classified by other agencies on the basis of carcinogenicity. Furfural also met the ecological categorization criterion for inherent toxicity to aquatic organisms but did not meet the criteria for persistence and bioaccumulation potential. Therefore, the focus of this assessment relates primarily to human health aspects.

According to information submitted under section 71 of CEPA 1999, between 100 000 and 1 000 000 kg were imported into, and used in Canada in 2006. In Canada, all uses of furfural identified as a result of a survey conducted under section 71 of CEPA 1999 are industrial uses. Furfural is naturally occurring in a variety of foods and beverages (e.g. fruits and vegetables), and can also be formed during the thermal processing of food. It can also be added to foods as a flavouring agent. Based on available information on sources and uses of furfural, the general population is expected to be exposed to furfural predominantly from its naturally occurring presence in food but also from environmental media (ambient and indoor air), and from use of consumer products containing the substance.

International agencies have reviewed the collective information on carcinogenicity and have found the evidence limited. On the basis of the available information regarding genotoxicity, and conclusions from international agencies, furfural is not likely to be genotoxic and a threshold approach is used for risk characterization. Critical effects for characterization of risk to human health from exposure to furfural via the oral route are liver effects and via the inhalation route are effects on nasal tissue.

The focus of risk characterization for human health was on general population exposures to furfural from sources other than its naturally occurring presence in foods (indoor and ambient air, consumer products) and margins of exposure were considered adequate to address uncertainty in the health effects and exposure databases. It is, therefore, proposed to conclude that furfural is not entering the environment in a quantity or concentration or under conditions that may constitute a danger in Canada to human life or health.

Furfural does not meet the criteria for persistence and bioaccumulation as set out in the Persistence and Bioaccumulation Regulations. While the substance may have the potential to cause adverse effects in sensitive aquatic organisms exposed for long periods of time to relatively low concentrations, a conservative risk quotient analysis determined that exposure concentrations derived from anthropogenic sources of furfural into the Canadian environment are unlikely to reach levels seen to elicit adverse effects in organisms. On the basis of low persistence and bioaccumulation potential, as well as low exposure concentrations in the environment, it is proposed to conclude that furfural is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

This substance will be considered for inclusion in the Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment

Proposed conclusion

Based on the information available, it is proposed to conclude that 2-Furancarboxaldehyde does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance2-Propenoic acid, ethyl ester, CAS No. 140-88-5— specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 2-Propenoic acid, ethyl ester is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that the substance does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on the substance at this time under section 77 of the Act.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment of 2-Propenoic Acid, Ethyl Ester

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of 2-Propenoic acid, ethyl ester (ethyl acrylate), Chemical Abstracts Service Registry No. 140-88-5. The substance ethyl acrylate was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. Ethyl acrylate was identified as a high priority as it was considered to pose the “greatest potential for exposure” of individuals in Canada and it is classified by other agencies on the basis of carcinogenicity. The substance did not meet the ecological categorization criteria for persistence, bioaccumulation potential or inherent toxicity to aquatic organisms.

According to information submitted under section 71 of CEPA 1999, ethyl acrylate was not manufactured by any company in Canada in the calendar year 2006 above the 100 kg reporting threshold. However, between 1 000 000 and 10 000 000 kg of ethyl acrylate was reported to have been imported in 2006. The major use of ethyl acrylate is in the manufacture of polymers and copolymers. Releases of ethyl acrylate to the environment from these sources do occur. However, exposure of the general population of Canada to ethyl acrylate is not expected to occur at any appreciable level.

As ethyl acrylate was classified on the basis of carcinogenicity by international regulatory agencies, carcinogenicity was a key focus for this screening assessment. Induction of forestomach tumours was observed in rats and mice that were administered ethyl acrylate by oral gavage for two years. However, no induction of tumours was observed by other routes of administration, including oral (drinking water), inhalation and dermal. Collective evidence from genotoxicity studies suggests that ethyl acrylate is not likely to be mutagenic but may exert some clastogenic effects in vitro. While the mode of induction of tumours has not been fully elucidated, sustained forestomach hyperplasia has been suggested to be a precursor event. Therefore, a threshold approach is used to characterize risk to human health.

Margins between upper-bounding estimates of exposure to ethyl acrylate from environmental media, food and the use of consumer products and levels associated with effects in experimental animals are considered to be adequately protective to account for uncertainties in the health effects and exposure databases.

Based on the information presented in this draft screening assessment, it is proposed to conclude that ethyl acrylate is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Based on available empirical data and modelling results, ethyl acrylate is not expected to be persistent or to bioaccumulate in the environment. The substance therefore does not meet the persistence criteria or the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, available empirical data suggest that the substance has a moderate to high potential to be toxic to aquatic organisms. However, based on a comparison of predicted no-effect concentrations with estimated reasonable worst-case environmental exposure concentrations, it is considered unlikely that ethyl acrylate is causing ecological harm in Canada.

Based on the information available, it is proposed to conclude that ethyl acrylate is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

This substance will be considered for inclusion in the Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that 2-Propenoic acid, ethyl ester does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substanceHexanoic acid, 2-ethyl-, CAS No. 149-57-5 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Hexanoic acid, 2-ethyl- is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that the substance does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on the substance at this time under section 77 of the Act.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Hexanoic acid, 2-ethyl-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Hexanoic acid, 2-ethyl- (2-ethylhexanoic acid), Chemical Abstracts Service Registry No. 149-57-5. This substance was identified in the categorization of the Domestic Substances List as a high priority for action under the Chemicals Management Plan Challenge initiative. The substance 2-ethylhexanoic acid (2-EHA) was identified as a high priority as it was considered to pose “greatest potential for exposure” (GPE) of individuals in Canada and is classified by the European Commission on the basis of developmental toxicity. The substance did not meet the ecological categorization criteria for persistence, bioaccumulation potential or inherent toxicity to aquatic organisms.

According to information reported under section 71 of CEPA 1999, 2-EHA was not manufactured in Canada in 2006 above the reporting threshold of 100 kg, but was imported into the country in a quantity ranging from 100 000 to 1 000 000 kg in 2006. The major use of 2-EHA is in the preparation of metal salts used in various applications including as drying agents in paint and inks. The substance 2-ethylhexanoic acid is also used to produce an ester utilized as a plasticizer. Since 2-EHA is primarily an industrial intermediate, the finished products will likely contain derivatives and not the substance.

Data were identified for 2-EHA concentrations in the Canadian environment (water and sediment), as well as concentrations in influents, effluents and biosolids from a number of wastewater treatment plants in Quebec, Canada. In 2006, the majority of 2-EHA in Canada was sent to non-hazardous, off-site waste management. Limited data were available regarding concentrations of 2-EHA in food.

The critical health effect associated with exposure to 2-EHA is developmental toxicity, based on observations in experimental animals. In addition, effects on the liver and stomach and reduced body weight gain were observed following repeated-dose exposure to 2-EHA and 2-ethylhexanol, which is metabolized extensively to 2-EHA. The margins between upper-bounding estimates of exposure from environmental media and food and consumer products (alkyd paint) and critical effect levels in experimental animals are considered adequate to address uncertainties in the health effects and exposure databases.

On the basis of the adequacy of the margins between upper-bound estimates of exposure to 2-EHA and critical effect levels, it is proposed to conclude that 2-EHA is a substance that is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

On the basis of ecological hazard and estimated releases of 2-EHA it is proposed to conclude that the substance is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. The substance 2-EHA does not meet the criteria for persistence or bioaccumulation as set out in the Persistence and Bioaccumulation Regulations.

This substance will be considered for inclusion in the Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that Hexanoic acid, 2-ethyl- does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substanceSiloxanes and Silicones, Me 3,3,3-trifluoropropyl, Me vinyl, hydroxy-terminated, CAS No. 68952-02-3 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Siloxanes and Silicones, Me 3,3,3-trifluoropropyl, Me vinyl, hydroxy-terminated is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that the substance does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on the substance at this time under section 77 of the Act.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Siloxanes and Silicones,
Me 3,3,3-trifluoropropyl, Me vinyl, hydroxy-terminated

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Siloxanes and silicones, Me 3,3,3-trifluoropropyl, Me vinyl, hydroxy-terminated (MVTFS), Chemical Abstracts Service Registry No. 68952-02-3. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance MVTFS was not considered to be a high priority for assessment of potential risks to human health, based on the application of the simple exposure and hazard tools developed for categorization of substances on the Domestic Substances List (DSL). Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

The substance MVTFS was classified as an organic UVCB (Unknown or Variable Composition, Complex Reaction Products or Biological Material) during the DSL categorization. Based on new information received, the substance is considered to be an organic siloxane polymer substance.

The substance is used in Canada primarily for the manufacturing of adhesives and synthetic rubber. It is not naturally produced in the environment. It is not reported to be manufactured in Canada; however, between 10 000 and 100 000 kg of the polymer were imported into the country in 2006.

Based on certain assumptions and reported use patterns in Canada, most of the substance ends up in waste disposal sites. A small fraction is estimated to be released to wastewater, and to a lesser extent air and land, during the industrial use stage, while the majority is expected to end up in landfill at waste disposal sites.

Based on the available information, it is determined that the form of MVTFS in commerce in Canada meets the reduced regulatory requirement polymer criteria as specified in the New Substances Notification Regulations (Chemicals and Polymers). The substance MVTFS is expected to be non-volatile and insoluble in water, with a specific gravity heavier than water. The substance is expected to display resistance to heat, some fluid and chemical attack, as well as to demonstrate a low glass transition temperature. The polymer is anticipated to exist in a rubber-like state at environmental temperatures and remain functional within a wide range of temperatures.

Based on the read-across data of the physical and chemical properties for its analogues, MVTFS is expected to be persistent in the environment. Furthermore, based on consideration of recently identified information on the bioaccumulation of an analogous polymer, and taking into account the high molecular weight of MVTFS, the polymer is not likely to be bioavailable to environmental organisms and is not anticipated to have significant potential for bioaccumulation. It is therefore proposed to conclude that the substance meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, recently identified experimental toxicity data for the analogous polymer and the model predictions on the hydrolysis products suggest that the polymer has a low potential to cause harm to organisms in the environment.

For this screening assessment, a very conservative exposure scenario was selected in which an industrial operation (user of the polymer) discharges MVTFS into the aquatic environment. The predicted environmental concentration in water (PEC) for the polymer was well below the predicted no-effect concentration (PNEC) for aquatic organisms. Therefore, based on the information presented in this screening assessment, it is proposed to conclude that MVTFS is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

Empirical health effects data were not identified for MVTFS. Based on limited health effects data for fluorosilicones which have similar structures, MVTFS is not considered to demonstrate high hazard potential.

Exposure of the general population to MVTFS through environmental media (air, drinking water and soil), or in food and beverages, is expected to be negligible. General population exposure from use of consumer products containing MVTFS is not expected. Accordingly, risk to human health from exposure to MVTFS in Canada is considered to be low. It is thus proposed to conclude that MVTFS is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Given the complexity associated with the polymer formulation and the potentially hazardous properties associated with low molecular weight polymers, there is concern that new activities for MVTFS which have not been identified or assessed under CEPA 1999 could lead to the substances meeting the criteria as set out in section 64 of the Act. Therefore, it is recommended that the DSL be amended to indicate that MVTFS meets the reduced regulatory requirement polymer criteria. Should other forms of MVTFS not meeting the reduced regulatory requirement polymer criteria be introduced on the Canadian market, those forms would be subject to the requirements of the New Substances Notification Regulations.

Proposed conclusion

Based on the information available, it is proposed to conclude that the reduced regulatory requirement form of Siloxanes and Silicones, Me 3,3,3-trifluoropropyl, Me vinyl, hydroxy-terminated does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substanceSiloxanes and Silicones, di-Me, hydrogen-terminated, CAS No. 70900-21-9 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas the substance Siloxanes and Silicones, di-Me, hydrogen-terminated is on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that the substance does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on the substance at this time under section 77 of the Act.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Siloxanes
and Silicones, di-Me, hydrogen-terminated

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Siloxanes and Silicones, di-Me, hydrogen-terminated (MHDnMH), Chemical Abstracts Service Registry No. 70900-21-9. This substance was identified as a high priority for screening assessment and included in the Challenge because, based on model predictions, it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance MHDnMH was not considered to be a high priority for assessment of potential risks to human health, based on the application of the simple exposure and hazard tools developed for categorization of substances on the Domestic Substances List (DSL). Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

The substance MHDnMH was classified as an organic UVCB (Unknown or Variable Composition, Complex Reaction Products or Biological Material) during the DSL categorization. Based on new information received, the substance is considered to be an organic siloxane polymer.

The substance MHDnMH is not naturally produced in the environment. In 2006, between 10 000 and 100 000 kg of the substance were manufactured in Canada, and less than 100 kg were imported into the country.

Based on reported use, MHDnMH is manufactured as an intermediate polymer, and then exported in bulk form out of the country for producing plastics. During the industrial process, a small amount of the polymer is released to wastewater, and to a lesser extent air and land; however, the total environmental release is not significant.

Based on the available information, it is determined that the form of MHDnMH in commerce in Canada meets the Reduced Regulatory Requirement polymer criteria as specified in the New Substances Notification Regulations (Chemicals and Polymers). Given that polymers are often complex mixtures and the molecular weight of a polymer varies as a function of the number of repeating units, two forms of the polymer of different molecular weights were considered in this assessment. This was done in order to address concerns relating to both average (e.g. MHDnMH where n = 34) and low (e.g. MHDnMH where n = 5) molecular weight forms of the polymer.

The substance is expected to be persistent in the environment. Furthermore, based on consideration of recently identified information for an analogue polymer on the potential for bioaccumulation, and taking into account its relatively large molecular size, the substance is not likely to be bioavailable and is expected to have a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, new modelled toxicity data for the substance and experimental data for an analogue polymer suggest that MHDnMH has a low potential to cause harm to organisms in water, soil, and sediment.

For this screening assessment, a very conservative exposure scenario was selected in which an industrial operation discharges MHDnMH into aquatic environment. The predicted environmental concentration in water was well below the predicted no-effect concentration calculated for aquatic organisms. Therefore, based on the information presented in this screening assessment, it is expected that MHDnMH is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

Empirical health effects data were not identified for MHDnMH. Based on health effects data about the analogue polydimethylsiloxane (PDMS), and on the weight-of-evidence-based risk assessments for PDMS conducted by international agencies, it is considered that MHDnMH demonstrates low hazard potential.

Based on the estimated concentrations of MHDnMH in environmental media (air, drinking water and soil), exposure of the general population is expected to be negligible. General population exposure can occur through use of consumer products containing MHDnMH. Margins between conservative upper-bounding estimates of exposure for MHDnMH and effect levels from health effects studies with the analogue, PDMS, are considered adequate to address uncertainties in the health effects and exposure databases. It is therefore proposed to conclude that MHDnMH is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Given the complexity associated with the polymer formulation and the potentially hazardous properties associated with low molecular weight polymers, there is concern that new activities for MHDnMH which have not been identified or assessed under CEPA 1999 could lead to the substance meeting the criteria as set out in section 64 of the Act. Therefore, it is recommended that the DSL be amended to indicate that MHDnMH meets the reduced regulatory requirement polymer criteria. Should other forms of MHDnMH not meeting the reduced regulatory requirement polymer criteria be introduced on the Canadian market, those forms would be subject to the requirements of the New Substances Notification Regulations.

Proposed conclusion

Based on the information available, it is proposed to conclude that the reduced regulatory requirement form of Siloxanes and Silicones, di-Me, hydrogen-terminated does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of six substances — Bismuthine, triphenyl-, CAS No. 603-33-8; Cyclotetrasiloxane, heptamethylphenyl-, CAS No. 10448-09-6; Benzene, 1,1 ′ -(chlorophenylmethylene)bis[4-methoxy-, CAS No. 40615-36-9; Phenol, 2-phenoxy-, trichloro deriv., CAS No. 64111-81-5; Siloxanes and Silicones, di-Me, reaction products with Me hydrogen siloxanes and 1,1,3,3-tetramethyldisiloxane, CAS No. 69430-47-3; and Phenol, 4,4 -(1-methylethylidene)bis-, reaction products with hexakis(methoxymethyl)melamine, CAS No. 125328-28-1 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Bismuthine, triphenyl-; Cyclotetrasiloxane, heptamethylphenyl-; Benzene, 1,1′-(chlorophenylmethylene)bis [4-methoxy-; Phenol, 2-phenoxy-, trichloro deriv.; Siloxanes and Silicones, di-Me, reaction products with Me hydrogen siloxanes and 1,1,3,3-tetramethyldisiloxane; and Phenol, 4,4 -(1-methylethylidene)bis-, reaction products with hexakis (methoxymethyl)melamine are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on the substances pursuant to section 74 of the Act is annexed hereby;

Whereas it is proposed to conclude that the substances do not meet any of the criteria set out in section 64 of the Act; and

Whereas the Minister of the Environment intends to amend the Domestic Substances List, under subsection 87(3) of the Act, to indicate that subsection 81(3) thereof applies with respect to these substances,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on these substances at this time under section 77 of the Act.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment of the Six Substances Listed Below

CAS RN*

DSL Name

603-33-8

Bismuthine, triphenyl-

10448-09-6

Cyclotetrasiloxane, heptamethylphenyl-

40615-36-9

Benzene, 1,1′-(chlorophenylmethylene)bis[4-methoxy-

64111-81-5

Phenol, 2-phenoxy-, trichloro deriv.

69430-47-3

Siloxanes and Silicones, di-Me, reaction products with Me hydrogen siloxanes and 1,1,3,3-tetramethyldisiloxane

125328-28-1

Phenol, 4,4 -(1-methylethylidene)bis-, reaction products with hexakis(methoxymethyl)melamine

*CAS RN = Chemical Abstracts Service Registry Number

The above six substances on the Domestic Substances List (DSL) were identified as high priority for screening assessment, to be part of the Challenge, because they meet the ecological categorization criteria for persistence (P) and bioaccumulation (B) and inherent toxicity to non-human organisms (iT), under paragraph 73(1)(b) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), and were believed to be in commerce in Canada. However, these substances were not identified as posing a high hazard to human health based on classifications by other national or international agencies for carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity. Also, they are not on the European Union’s Candidate List of Substances of Very High Concern for Authorisation.

Pursuant to paragraph 74(a) of CEPA 1999, the Ministers of the Environment and of Health have conducted a screening assessment on these substances.

Results from notices issued under paragraph 71(1)(b) of CEPA 1999 on March 4, 2006, and September 26, 2009, as part of the Challenge revealed no reports of industrial activity (import or manufacture) with respect to these substances in Canada, above the reporting threshold of 100 kg, for the specified reporting year of 2005 and 2006, respectively. These results indicate that in 2005 and 2006, these substances were not in use above the specified reporting threshold, and therefore the likelihood of exposure to this substance in Canada resulting from commercial activity is low. Other sources of entry into the environment have not been identified at this time.

Responses to the above notices issued under paragraph 71(1)(b) of CEPA 1999 and the accompanying questionnaire of September 26, 2009, also revealed no new information relevant to the PBiT properties of these substances. Given the lack of import or manufacture activity above the reporting threshold for these substances, no further collection or analysis relevant to the persistence, bioaccumulation and ecological effects of these substances, beyond what was done for categorization, has been conducted. Therefore, the decisions on PBiT properties made during categorization remain unchanged and accordingly these substances are considered to be highly hazardous to non-human organisms. They are also considered to meet the criteria for both persistence and bioaccumulation as set out in the Persistence and Bioaccumulation Regulations.

As mentioned above, since the results from notices issued under paragraph 71(1)(b) of CEPA 1999 on March 4, 2006, and September 26, 2009, indicate that these substances are not in use above the specified reporting threshold, the likelihood of exposure to the general population in Canada is considered to be low; hence, the potential risk to human health is considered to be low. Furthermore, these substances were not identified as posing a high hazard to human health based on classifications by other national or international agencies for carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity. Also, they are not on the European Union’s Candidate List of Substances of Very High Concern for Authorisation.

Proposed conclusion

Based on available information, and until new information is received indicating that these substances are entering, or may enter the environment, from commercial activity or from other sources, it is proposed to conclude that the above substances are currently not entering or likely to enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or constitute a danger to the environment on which life depends or that constitute a danger in Canada to human life or health. Therefore, it is proposed to conclude that they do not meet any of the criteria as set out in section 64 of CEPA 1999.

Because these substances are listed on the Domestic Substances List, their import and manufacture in Canada are not subject to notification under subsection 81(1) of CEPA 1999. Given the hazardous PBiT properties of these substances, there is concern that new activities that have not been identified or assessed could lead to these substances meeting the criteria set out in section 64 of the Act. Therefore, it is recommended to amend the Domestic Substances List, under subsection 87(3) of the Act, to indicate that subsection 81(3) of the Act applies with respect to these substances so that new manufacture, import or use of these substances be subject to notification and undergo ecological and human health risk assessments.

The draft Screening Assessment for these substances is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).