Vol. 145, No. 37 — September 10, 2011

ARCHIVED — Supplement

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of Final Decision after Screening Assessment of Substances — Batch 6

Publication of final decision after screening assessment of a substance — 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 (Acid Red 111), CAS No. 6358-57-2 — specified on the Domestic Substances List (subsection 77(6) 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 Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby;

Whereas the Ministers of the Environment and of Health have identified no manufacture or importation activity for the substance above 100 kg per calendar year;

Whereas it is concluded 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 pursuant to subsection 87(3) of the Act to indicate that new activities relating to the substance are subject to subsection 81(3),

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.

PETER KENT
Minister of the Environment

LEONA AGLUKKAQ
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 initiative under the Chemicals Management Plan 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 upon application of the simple exposure and hazard tools developed 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. Other 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 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 sulfonated azo dyes with a naphthalene ring, as well as results of quantitative structure-activity relationship modelling, suggests that Acid Red 111 is persistent in aerobic environments (i.e. water, soil, and 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 three other sulfonated acid dyes of similar molecular structure suggest that this substance does not cause acute harm to aquatic organisms at low concentrations.

For this screening assessment, a conservative environmental release 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 releases and concentrations in the aquatic environment. The predicted environmental concentration in water for this substance (0.03 mg/L) was below the predicted no-effect concentration (0.04 mg/L) for sensitive aquatic organisms, resulting in a risk quotient of 0.7.

Based on the ecological information available, it is concluded 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.

For the human health assessment, 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, and 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 that 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. It is concluded that Acid Red 111 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.

Conclusion

Based on the information available, it is concluded 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.

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 Substances 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 is notified and undergoes ecological and human health risk assessments.

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

Publication of final decision after screening assessment of a substance — Phenol, 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(6) 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 Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is concluded 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.

PETER KENT
Minister of the Environment

LEONA AGLUKKAQ
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 initiative under the Chemicals Management Plan 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 upon application of the simple exposure and hazard tools developed 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. Based on information provided in response to Canada’s section 71 survey under CEPA 1999, Disperse Orange 29 was not reported to be manufactured in Canada in 2006 or 2005. One company reported importing 2 000 kg of the substance into the country in 2006. In 2005, two companies reported importing Disperse Orange 29 into Canada, with one company importing between 100 and 1 000 kg and another company importing 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 sewers (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, Disperse Orange 29 will likely be found in sediments if released directly to water and, possibly to a lesser extent, in agricultural soil that has been amended with biosolids. 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 the physical and chemical properties of Disperse Orange 29, it is expected to be persistent in soil, sediment, and water. However, new experimental data relating to the bioaccumulation potential of two relatively close structural analogues suggest 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 to low concentrations.

For this screening assessment, a conservative ecological 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 concluded 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 of exposure. It is concluded 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.

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.

Conclusion

Based on the information available, it is concluded 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 Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication of final decision after screening assessment of a substance — Butanamide, 2,2′-[(3,3′-dimethoxy[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxo-, CAS No. 7147-42-4 — specified on the Domestic Substances List (subsection 77(6) 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 Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is concluded 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.

PETER KENT
Minister of the Environment

LEONA AGLUKKAQ
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- (herein referred to as 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 initiative under the Chemicals Management Plan 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 upon application of the simple exposure and hazard tools developed 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 related to pigments in general, 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 disazo diarylide 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.

Biodegradation studies for disazo diarylide pigment analogues along with modelled data for BPAOPB suggest that little degradation of BPAOPB would occur in aerobic environments (i.e. water, sediment, soil). Given the physical and chemical properties of BPAOPB and other disazo diarylide pigments (i.e. solid particle nature, high molecular weight, large cross-sectional diameter, low water solubility, low octanol solubility), and bioconcentration studies on one analogue pigment, it is expected that BPAOPB 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 the substance does not cause acute harm to aquatic organisms.

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

Based on the ecological information available, it is concluded 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.

For the human health assessment, 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 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 concluded 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.

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.

Conclusion

Based on the information available, it is concluded 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 Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication of final decision after screening assessment of a substance — Phosphonic 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(6) 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 a summary of the Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is concluded 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.

PETER KENT
Minister of the Environment

LEONA AGLUKKAQ
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 initiative under the Chemicals Management Plan 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 upon application of the simple exposure and hazard tools developed for categorization of substances on the Domestic Substances List.

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 land application of biosolids. 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 is expected to adsorb strongly to mineral surfaces. Therefore, PADMEC would likely be found mainly in water and sediments.

The substance PADMEC is expected to degrade slowly in the environmental media where it may be released. It is 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.

For this screening assessment, 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. Comparison of the predicted environmental concentration and predicted no-effect concentration indicates a low potential for harm to aquatic organisms from this substance.

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. Accordingly, risk to the general population is considered to be low.

Based on the information available, it is concluded 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, 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.

Conclusion

Based on the information available, it is concluded 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 Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication of final decision after screening assessment of a substance — Hexanedioic acid, bis(2-ethylhexyl) ester, CAS No. 103-23-1 — specified on the Domestic Substances List (subsection 77(6) 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 the summary of the Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is concluded 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 His 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 are releasing a proposed risk management approach document for this substance on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca) to continue discussions with stakeholders on the manner in which the Ministers intend to develop a proposed regulation or instrument respecting preventive or control actions in relation to the substance.

Public comment period on the proposed risk management approach document

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the proposed risk management approach document. More information regarding the proposed risk management approach 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), substances@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.

PETER KENT
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment 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 (or 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 initiative under the Chemicals Management Plan, 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 upon classification by other agencies on the basis of carcinogenicity. The substance did not meet the ecological categorization criteria for persistence or bioaccumulation, but did meet the criteria for inherent toxicity to aquatic organisms.

According to information reported under section 71 of CEPA 1999, DEHA was manufactured in Canada in 2006 at quantities between 1 million and 10 million kilograms. Approximately 250 000 kg of DEHA was imported into Canada 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 (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 resulting margins of exposure resulting from use of certain cosmetics and personal care products are potentially inadequate.

On the basis of the potential inadequacy of the margins between estimated exposures to DEHA and critical-effect levels, it is concluded that DEHA is a substance that is entering or may 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.

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 in water, and that it is also not expected to persist for long periods 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.

A comparison of the predicted no-effect concentration with concentrations measured in Canadian surface water and effluents, as well as realistic worst-case estimated exposure concentrations determined for site-specific industrial releases to water, suggests that harm to aquatic organisms is possible at many locations in Canada.

On the basis of ecological hazard and estimated exposures, it is concluded that DEHA 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. 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.

Conclusion

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

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

Publication of final decision after screening assessment of a substance — 2-Furancarboxaldehyde, CAS No. 98-01-1 — specified on the Domestic Substances List (subsection 77(6) 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 Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is concluded 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.

PETER KENT
Minister of the Environment

LEONA AGLUKKAQ
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 as a high priority for screening assessment and included in the Challenge initiative under the Chemicals Management Plan because it was determined to present “greatest potential for exposure” to 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.

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 the section 71 survey under CEPA 1999 are industrial uses. Furfural occurs naturally 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 the sources and uses of furfural, it is expected that the general population will be predominantly exposed to it 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 on the liver, and via the inhalation route, on nasal tissue.

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

Furfural does not meet the criteria for persistence or bioaccumulation potential 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 to relatively low concentrations for long periods of time, a conservative risk quotient analysis determined that exposure concentrations derived from anthropogenic sources of furfural in the Canadian environment are unlikely to reach levels which 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 concluded 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.

Conclusion

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

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

Publication of final decision after screening assessment of a substance — 2-Propenoic acid, ethyl ester, CAS No. 140-88-5 — specified on the Domestic Substances List (subsection 77(6) 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 Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is concluded 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.

PETER KENT
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment Report 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 initiative under the Chemicals Management Plan. 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 adequate to address uncertainties in the health effects and exposure databases.

Based on the information presented in this screening assessment, it is concluded 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 concluded 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.

Conclusion

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

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

Publication of final decision after screening assessment of a substance — Hexanoic acid, 2-ethyl-, CAS No. 149-57-5 — specified on the Domestic Substances List (subsection 77(6) 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 Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is concluded 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.

PETER KENT
Minister of the Environment

LEONA AGLUKKAQ
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- (or 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 Challenge initiative under the Chemicals Management Plan. 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 total 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-EHA is also used to produce an ester used as a plasticizer, but it is primarily an industrial intermediate whereby the resulting derivatives are contained in the finished products.

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 municipal wastewater treatment plants in Quebec, Canada. In 2006, the majority of 2-EHA in Canada was sent to non-hazardous, off-site waste management facilities. Limited data were available regarding concentrations of 2-EHA in food.

The critical human 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 exposures 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-bounding estimates of exposure to 2-EHA and critical effect levels, it is concluded 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.

The substance 2-EHA is a highly soluble substance that primarily exists in its ionized (negatively charged) form in water at environmentally relevant pHs. Empirical and modelled data demonstrate that 2-EHA biodegrades quickly in the environment and has a low potential to accumulate in the lipid tissues of organisms. Acute and chronic toxicity values indicate that the substance is moderately toxic to aquatic organisms (acute LC₅₀ or EC₅₀ > 1.0 mg/L and < 100 mg/L). Realistic estimates of exposure were determined for site-specific industrial releases and consumer releases to water. The predicted environmental concentrations in water of this substance (as well as actual concentrations measured in Canadian river water and effluents) are estimated to be below the predicted no-effect concentration for sensitive aquatic organisms, resulting in risk quotients lower than one.

On the basis of its low ecological hazard and conservatively estimated releases of 2-EHA, it is concluded 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.

Conclusion

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

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

Publication of final decision after screening assessment of a substance — Siloxanes and Silicones, Me 3,3,3-trifluoropropyl, Me, vinyl, hydroxy-terminated, CAS No. 68952-02-3 — specified on the Domestic Substances List (subsection 77(6) 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 Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is concluded 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.

PETER KENT
Minister of the Environment

LEONA AGLUKKAQ
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 initiative under the Chemicals Management Plan 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 upon application of the simple exposure and hazard tools developed for categorization of substances on the Domestic Substances List (DSL).

The substance MVTFS was originally 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 is expected to end 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.

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). 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 across 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. 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 concluded 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, identified experimental toxicity data for an analogous polymer and the model predictions on the hydrolysis products indicate that the polymer has a low potential to cause harm to organisms in the environment.

For this screening assessment, a conservative exposure scenario was developed in which an industrial operation (user of the polymer) discharges MVTFS into the aquatic environment. The predicted environmental concentration in water for the polymer was well below the predicted no-effect concentration for aquatic organisms. Therefore, based on the information presented in this screening assessment, it is concluded 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 through 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 concluded 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 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 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.

Conclusion

Based on the information available, it is concluded 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 Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication of final decision after screening assessment of a substance — Siloxanes and Silicones, di-Me, hydrogen-terminated, CAS No. 70900-21-9 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas Siloxanes and Silicones, di-Me, hydrogen-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 Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby; and

Whereas it is concluded 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.

PETER KENT
Minister of the Environment

LEONA AGLUKKAQ
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 (MHD_nMH), Chemical Abstracts Service Registry No. 70900-21-9. This substance was identified as a high priority for screening assessment and included in the Challenge initiative under the Chemicals Management Plan 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 MHD_nMH was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed for categorization of substances on the Domestic Substances List (DSL).

The substance MHD_nMH was originally 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 MHD_nMH 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, MHD_nMH is manufactured as an intermediate polymer, 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, to air and land; however, the total environmental release is not significant.

Based on the available information, it is determined that the form of MHD_nMH 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 number-average (e.g. MHD_nMH where n = 34) and low (e.g. MHD_nMH where n = 5) molecular weight forms of the polymer.

Information about an analogous polymer, polydimethylsiloxane (PDMS), has been used to assess MHD_nMH. Based on the read-across data of the analogue, the substance is expected to be persistent in the environment. Based on the information about the analogue 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 about the substance and experimental data about an analogous polymer indicate that MHD_nMH has a low potential to cause harm to organisms in water, soil, and sediment.

For this screening assessment, a conservative exposure scenario was developed in which an industrial operation discharges MHD_nMH into the aquatic environment. The predicted environmental concentration in water was well below the predicted no-effect concentration calculated for the aquatic organisms. Therefore, based on the information presented in this screening assessment, it is expected that MHD_nMH 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 data about the health effects of MHD_nMH were not identified. Based on health effects data about PDMS, and on the weight-of-evidence-based risk assessments of PDMS conducted by international agencies, it is considered that MHD_nMH demonstrates low hazard potential.

Based on the estimated concentrations of MHD_nMH in environmental media (air, drinking water and soil), exposure to the general population is expected to be negligible. Exposure to the general population can occur through use of consumer products containing MHD_nMH. Margins between conservative upper-bounding estimates of exposure to MHD_nMH and effect levels from health effects studies of the analogue (PDMS) are considered adequate to address uncertainties in the health effects and exposure databases. It is therefore concluded that MHD_nMH 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 involving MHD_nMH 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 MHD_nMH meets the reduced regulatory requirement polymer criteria. Should other forms of MHD_nMH 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.

Conclusion

Based on the information available, it is concluded 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 Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication of final decision 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 derivatives, 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(6) of the Canadian Environmental Protection Act, 1999)

Whereas Bismuthine, triphenyl-; Cyclotetrasiloxane, heptamethylphenyl-; Benzene, 1,1′-(chlorophenylmethylene)bis[4-methoxy-; Phenol, 2-phenoxy-, trichloro derivatives; 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 Screening Assessment conducted on the substances pursuant to section 74 of the Act is annexed hereby;

Whereas the Ministers of the Environment and of Health have identified no manufacture or importation activity for the substances above 100 kg per calendar year;

Whereas it is concluded that these 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 pursuant to subsection 87(3) of the Act to indicate that new activities relating to these substances are subject to subsection 81(3),

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.

PETER KENT
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment of
the six substances listed below

*CAS RN = Chemical Abstracts Service Registry Number

The above six substances on the Domestic Substances List (DSL) were identified as a high priority for screening assessment, to be part of the Challenge initiative under the Chemicals Management Plan, because they meet the ecological categorization criteria for persistence (P), 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 years of 2005 and 2006. These results suggest that, in 2005 and 2006, these substances were not in use above the specified reporting threshold, and therefore the likelihood of exposure to these substances 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 the 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.

Conclusion

Based on available information, it is concluded that Bismuthine, triphenyl-; Cyclotetrasiloxane, heptamethylphenyl-; benzene, 1,1′-(chlorophenylmethylene)bis[4-methoxy-; Phenol, 2-phenoxy-, trichloro derivatives; 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 do not meet any of the criteria 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). Given the hazardous 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 Screening Assessment for these substances 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 Substances List (section 68 of the Canadian Environmental Protection Act, 1999)

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

Whereas the summary of the Screening Assessment conducted on the substance pursuant to section 68 of the Canadian Environmental Protection Act, 1999 is annexed hereby; and

Whereas it is concluded 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.

PETER KENT
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment of Ethanedial

The Ministers of the Environment and of Health have conducted an assessment of ethanedial, Chemical Abstracts Service Registry No. 107-22-2. The substance ethanedial was identified following the categorization of the Domestic Substance List as a high priority for action under the Challenge initiative under the Chemicals Management Plan. 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.

Hydrated forms of ethanedial can occur naturally. It is 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 imported over 136 000 kg in 2006. In addition, between 100 000 and 1 000 000 kg of ethanedial was used in Canada in that year. Between 10 000 and 100 000 kg of ethanedial was reported to be 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, indoor air) and from its naturally occuring 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 the 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 repeat-dose studies. Decreased body and organ weights, and decreased food intake, were the most consistently observed effects in rats exposed by the oral route in repeat-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 concluded 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 type of aquatic organism.

Based on the information available, it is concluded 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.

Conclusion

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

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