Whereas Benzene, (chloromethyl)- (benzyl chloride) 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 final Screening Assessment conducted on benzyl chloride pursuant to section 74 of the Act is annexed hereby; and

Whereas benzyl chloride 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 benzyl chloride be added to Schedule 1 to 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 the public 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), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment of Benzene, (chloromethyl)-

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 Benzene, (chloromethyl)-, also known as benzyl chloride, Chemical Abstracts Service Registry No. 100-44-7. This substance was identified in the categorization of the Domestic Substances List (DSL) as a high priority for action under the Challenge. Benzyl chloride was identified as presenting “greatest potential for exposure” of individuals in Canada and had been classified by other agencies on the basis of carcinogenicity and genotoxicity. Although the substance met the categorization criteria for persistence, it did not meet the criteria for bioaccumulation potential or inherent toxicity to aquatic organisms; therefore, the focus of this assessment relates primarily to human health aspects.

According to data submitted in response to a notice issued under section 71 of the Act, no persons in Canada reported manufacturing benzyl chloride in a quantity greater than or equal to the reporting threshold of 100 kg for the 2006 calendar year. However, it was reported that 100 000–1 000 000 kg were imported into Canada in that year. The response to the section 71 notice indicated that benzyl chloride is mainly used in Canada as a chemical intermediate for the synthesis of quaternary ammonium compounds, which are used primarily as hard surface sanitizers, corrosion inhibitors, fungicides in industrial cleaners and bactericides in surfactants in household and personal care products. Based on information presented in the available scientific and technical literature, benzyl chloride is also used as an intermediate in the organic synthesis of benzyl alcohol and benzyl butyl phthalate, which are used in a wide spectrum of applications, including pharmaceuticals, cosmetic formulations, flavour products, solvents, textile dyes and plasticizers in vinyl flooring and other flexible polyvinyl chloride uses, such as food packaging.

Emissions of benzyl chloride into the ambient environment are expected to be primarily from anthropogenic sources where it is used as a chemical intermediate. However, due to its use in captive reactions, such emissions are likely to be low. Benzyl chloride has been detected in stack emissions from waste incineration, and it might also be present in atmospheric emissions from the burning of some fossil fuels. Based on its physical and chemical properties, the principal route of exposure to benzyl chloride for the general population is likely through inhalation. Exposures due to use of products containing residual quantities of benzyl chloride are predicted to be low.

Based principally on weight-of-evidence-based assessments of international and other national agencies, the critical effect for the characterization of risks to human health from exposure to benzyl chloride is carcinogenicity. Increased incidences of tumours at multiple sites, including the forestomach, thyroid, lung, liver and circulatory system, were observed in rats and mice exposed via the oral route. There was also limited evidence of skin tumours in mice dermally exposed to benzyl chloride. In addition, epidemiological studies suggested limited evidence of respiratory and digestive system cancers in occupationally exposed populations. Benzyl chloride was genotoxic in a wide range of in vitro studies as well as in some in vivo studies. Although the mode of induction of tumours by benzyl chloride has not been elucidated, it cannot be precluded that the tumours observed in experimental animals resulted from direct interaction with genetic material. On the basis of the carcinogenic potential of benzyl chloride, for which there may be a probability of harm at any exposure level, it is concluded that benzyl chloride is a substance that 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.

Benzyl chloride meets the criterion for persistence in air but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. Furthermore, it is expected to have a moderate potential for toxicity to aquatic organisms. Based on this information and the expected low environmental concentrations, it is concluded that benzyl chloride 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 included 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 benzyl chloride meets one or more of the criteria set out in section 64 of CEPA 1999.

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

Whereas 1,2-Benzenedicarboxylic acid, di-C_7-11-branched and linear alkyl esters 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 final Screening Assessment conducted on this substance pursuant to paragraph 68(b) of the Canadian Environmental Protection Act, 1999 is annexed hereby; and

Whereas this 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 this substance at this time.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment of 1,2-Benzenedicarboxylic acid, di-C_7-11-branched and linear alkyl esters

The Ministers of the Environment and of Health have conducted a screening assessment of 1,2-Benzenedicarboxylic acid, di-C_7-11-branched and linear alkyl esters (DHNUP), Chemical Abstracts Service Registry No. 68515-42-4. These substances (considered as one substance for risk assessment) were identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. DHNUP was identified as a high priority because it was considered to pose intermediate potential for exposure to individuals in Canada and had been classified by the European Commission on the basis of reproductive and developmental toxicity. Although DHNUP met the ecological categorization criterion for inherent toxicity to aquatic organisms, it did not meet the criteria for bioaccumulation potential or persistence.

In response to a notice issued under section 71 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), DHNUP was reported to be manufactured in a quantity in the range of 100 000–1 000 000 kg in 2006. The total quantity imported into Canada in the same calendar year was reported to be in the range of 10 000 000–100 000 000 kg. Manufacturing activity involving DHNUP has decreased significantly in Canada subsequent to the 2006 reporting year, and annual importation activity was estimated to have declined by over 90%. This reduction in the use of DHNUP in Canada occurred largely due to the decreased availability of the upstream plasticizer alcohols required for its synthesis. It is not known if the decline in DHNUP quantities in Canadian commerce is temporary or permanent. DHNUP’s principal use that has been identified as ongoing in Canada subsequent to the 2006 reporting year was as a plasticizer for PVC (polyvinyl chloride).

Population exposure to DHNUP through environmental media is expected to be negligible based on minimal environmental releases of DHNUP in Canada during the 2006 calendar year as identified in responses to a notice issued under section 71 of CEPA 1999. Population exposure to DHNUP in indoor air through end products is expected to be low, based on expected use patterns and conservative exposure estimates.

The health effects associated with exposure to DHNUP are primarily reproductive and developmental toxicity and liver toxicity, based on observations in experimental animals. The margins between conservative upper-bounding estimates of exposure from indoor air (from potential off-gassing of current or historical products containing DHNUP) and levels associated with effects in experimental animals are considered to be adequately protective.

Ecological exposure scenarios were developed based on the most recent (post-2006) information on commercial use to estimate releases into the aquatic environment from industrial operations and resulting aquatic concentrations. Environmental concentrations are estimated to be below those that would harm sensitive aquatic organisms. This indicates that the substance is unlikely to cause ecological harm in the aquatic environment.

On the basis of the adequacy of the margins between exposure to DHNUP in indoor air and critical effect levels in experimental animals, it is concluded that DHNUP 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 the information available, it is concluded that DHNUP 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. DHNUP does not meet the persistence or bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

This substance will be included in the upcoming 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 1,2-Benzenedicarboxylic acid, di-C_7-11-branched and linear alkyl esters does not meet any of the criteria set out in section 64 of CEPA 1999.

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

Whereas 1-Propene-3-chloro- (3-chloropropene) 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 final Screening Assessment conducted on 3-chloropropene pursuant to paragraph 68(b) of the Canadian Environmental Protection Act, 1999 is annexed hereby; and

Whereas the Ministers of the Environment and of Health have identified no manufacture or importation activity for 3-chloropropene above 100 kg per calendar year;

Whereas 3-chloropropene 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) of the Act thereof applies with respect to 3-chloropropene,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on 3-chloropropene at this time.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment of 1-Propene-3-chloro-

The Ministers of the Environment and of Health have conducted a screening assessment of 1-Propene, 3-chloro- (3-chloropropene), Chemical Abstracts Service Registry No. 107-05-1. This substance was identified in the categorization of the Domestic Substances List (DSL) as a high priority for action under the Challenge. The substance 3-chloropropene was identified as presenting an intermediate potential for exposure to individuals in Canada and had been classified by other agencies on the basis of carcinogenicity and genotoxicity. Although the substance met the ecological categorization criteria for inherent toxicity to aquatic organisms, it did not meet the criteria for persistence or bioaccumulation. Therefore, the focus of this assessment relates primarily to human health aspects.

Under information reported pursuant to section 71 of CEPA 1999, the total quantity of 3-chloropropene imported into Canada in 2006 was below the reporting threshold of 100 kg. It should be noted that 3-chloropropene was imported into Canada as its reacted form (as part of a polymer backbone) or as residues in end products. No manufacture or direct use of 3-chloropropene was reported by Canadian companies in that same year. However, acrylic polymers manufactured using 3-chloropropene are imported by companies in Canada to be used as formulants in personal care products. Based on information presented in the scientific and technical literature, 3-chloropropene is employed primarily in the production of epichlorohydrin, glycerine and quaternary ammonium compounds. The substance is also used as a chemical intermediate in the production of allyl compounds, cross-linking substances, pharmaceutical agents and agricultural chemicals.

The substance 3-chloropropene does not occur naturally in the environment. However, 3-chloropropene from anthropogenic sources may be released into the atmosphere and hydrosphere during its production, use and disposal. The principal route of exposure to the general population is likely through inhalation of ambient and indoor air and the use of personal care products containing the substance as a residual. Exposure from other media is likely negligible in comparison. Due to its use as a chemical intermediate in captive reactions, releases of 3-chloropropene to the ambient environment are expected to be low.

As 3-chloropropene was classified on the basis of carcinogenicity by other national and international agencies, carcinogenicity was a key focus for this screening assessment. Small increases in the incidence of forestomach tumours and lung tumours were observed in mice exposed orally and by intraperitoneal injection, respectively. No increases in tumour incidence were observed in mice exposed dermally to 3-chloropropene alone or in a limited study in rats exposed via oral gavage. The substance 3-chloropropene is an alkylating agent. Although 3-chloropropene was consistently genotoxic in a range of in vitro assays, it was not demonstrated to be genotoxic in the limited number of in vivo studies identified. Information from a limited epidemiological study demonstrated no increases in death due to cancer in workers exposed to 3-chloropropene. Thus, in light of the weak evidence of carcinogenicity, characterization of risk to human health was based on information on non-cancer effects.

Exposure to 3-chloropropene has been associated with non-cancer effects in experimental animals and in occupationally exposed humans, including neurotoxicity, reproductive and developmental toxicity and effects on the liver and kidneys. Margins between concentrations associated with neurological effects, considered to be the critical effects for risk characterization, and conservatively modelled estimates of exposure via inhalation during use of some personal care products that contain 3-chloropropene, and measured concentrations in ambient air are considered to be adequately protective, although only very limited information was available on the potential presence of the substance in products in Canada.

Based on the available information on the potential to cause harm to human health and the resulting margins of exposure for neurological effects, it is concluded that 3-chloropropene 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 3-chloropropene does not meet the criteria for persistence or bioaccumulation as set out in the Persistence and Bioaccumulation Regulations, but it may be harmful (acutely toxic) to some species at low concentrations of exposure. On the basis of its relatively low ecological hazard, its low concentrations measured historically in Canadian surface waters and effluents and its low quantity currently in commerce in Canada, it is concluded that 3-chloropropene 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.

Conclusion

Based on available information, it is concluded that 3-chloropropene does not meet any of the criteria set out in section 64 of CEPA 1999.

Because this substance is listed on the Domestic Substances List, its import and manufacture in Canada are not subject to notification under subsection 81(1). Given the hazardous properties 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 the substance so that new manufacture, import or use of this substance be subject to notification and undergo ecological and human health risk assessments.

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

Whereas 1,2-benzenedicarboxylic acid, bis(2-methoxyethyl) ester 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 final Screening Assessment conducted on this substance pursuant to paragraph 68(b) of the Canadian Environmental Protection Act, 1999 is annexed hereby;

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

Whereas this 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) of the Act 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 this substance at this time.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment of 1,2-Benzenedicarboxylic acid, bis(2-methoxyethyl) ester

The Ministers of the Environment and of Health have conducted a screening assessment of 1,2-Benzenedicarboxylic acid, bis(2-methoxyethyl) ester (di(methoxyethyl)phthalate, DMEP), Chemical Abstracts Service Registry No. 117-82-8. This substance was identified in the categorization of the Domestic Substances List (DSL) as a high priority for action under the Challenge. DMEP was identified as a high priority as it was considered to pose an intermediate potential for exposure of individuals in Canada and had been classified by the European Commission on the basis of reproductive and developmental toxicity. The substance did not meet the ecological categorization criteria for persistence, bioaccumulation or inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of DMEP relates principally to human health risks.

According to information reported under section 71 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), DMEP was not manufactured or imported in a quantity equal to or greater than the 100 kg reporting threshold or used in a quantity equal to or greater than the 1 000 kg reporting threshold in Canada in 2006. Historically, DMEP was used as a plasticizer and as a paint/coating additive in Canada. The general global applications of DMEP have included its use as a plasticizer and solvent.

Based on limited information on concentrations in environmental media and results from a survey under section 71 of CEPA 1999, exposure of the general population via the environment is expected to be low. No current presence of DMEP in consumer products in the Canadian marketplace was identified. The health effects associated with exposure to DMEP are primarily developmental and reproductive toxicity, based on limited study data on the substance and supported by the toxicological database for its metabolites. The margins between upper-bounding estimates of total daily intake of DMEP for the general population in Canada and exposure levels associated with critical health effects in experimental animals are considered to be adequately protective.

On the basis of the adequacy of the margins between conservative estimates of exposure to DMEP from environmental media, using the concentrations in indoor dust as a surrogate for exposure from soil/dust, and exposure levels associated with critical health effect in exposed experimental animals, it is concluded that DMEP 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 DMEP does not meet the criteria for persistence or bioaccumulation as set out in the Persistence and Bioaccumulation Regulations. On the basis of low ecological hazard and probable low exposure in the environment, based on the very low usage of DMEP in Canada, it is concluded that this 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.

Conclusion

Based on available information, it is concluded that 1,2-benzenedicarboxylic acid, bis(2-methoxyethyl) ester does not meet any of the criteria set out in section 64 of CEPA 1999.

Because this substance is listed on the Domestic Substances List, its import and manufacture in Canada are not subject to notification under subsection 81(1). Given the hazardous properties 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 the substance so that new manufacture, import or use of this substance be subject to notification and undergo ecological and human health risk assessments.

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

Whereas Methane, chloro- (methyl chloride) 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 final Screening Assessment conducted on methyl chloride pursuant to section 74 of the Act is annexed hereby; and

Whereas methyl chloride 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 methyl chloride at this time under section 77 of the Act.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment on Methane, chloro-

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 Methane, chloro- or methyl chloride, Chemical Abstracts Service Registry No. 74-87-3. This substance was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. Methyl chloride was identified as a high priority as it was considered to pose the “greatest potential for exposure” of individuals in Canada and it had been classified by the European Commission on the basis of carcinogenicity. Although methyl chloride met the ecological categorization criteria for persistence, it did not meet the criteria for potential for bioaccumulation and inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of methyl chloride relates primarily to human health risks.

According to information provided by Statistics Canada, 1 049 000 kg of methyl chloride were imported into Canada in 2006.

The most important industrial uses of methyl chloride are as a chemical intermediate in manufacturing processes in which methyl chloride is consumed. In Canada, the largest reported use of methyl chloride is as a solvent in the manufacture of butyl rubber and the next largest reported use is in the manufacture of quaternary ammonium compounds. Methyl chloride is not produced in Canada as a commercial product for sale.

Methyl chloride, a gas at room temperature, is ubiquitous in air. There are significant natural and anthropogenic sources of methyl chloride released principally to the atmosphere which include biomass burning, open oceans, plants, fungi, coal and waste combustion, and industrial processes. Methyl chloride is a by-product of combustion when biomass and fossil fuels are burned. Industrial facilities that burn large quantities of coal such as coal-fired power generating plants and integrated steel mills, as well as kraft pulp mills operating recovery boilers are sources of release of methyl chloride to the atmosphere from combustion processes. A butyl rubber plant is the largest point source of release of methyl chloride in Canada.

Methyl chloride has been measured in indoor and ambient air, and detected in a small percentage of samples of groundwater, surface water and municipally-treated drinking water. Dietary intake and the use of consumer products except for tobacco are expected to make a negligible contribution to human exposure to this substance.

As methyl chloride was classified on the basis of carcinogenicity by a national agency, carcinogenicity was a key focus for this screening assessment. In a two-year rodent inhalation bioassay, renal tumours were significantly increased in male mice from the high-concentration group. No tumours were observed in female mice or in rats of either sex. The tumours in male mouse kidney may be initiated by progression from hyperplasia due to regeneration following chronic high-concentration exposure, rather than by direct mutagenic activity of methyl chloride, and may not be relevant to humans, due to species differences in metabolism of methyl chloride.

The primary target organ for methyl chloride toxicity was identified in humans and in rodents as the central nervous system. The critical effect concentration was based on axonal swelling and degeneration in the spinal nerves of male and female mice exposed to methyl chloride for up to two years. Effects on male rat reproductive organs and male mouse kidney hyperplastic lesions and tumours were only observed at exposure concentrations well above the critical effect concentration. Comparison of the critical effect level in experimental animals with the upper bounding estimates of general population exposure from all sources results in acceptable margins of exposure for all age groups.

Methyl chloride meets the criteria for persistence in air, water, soil and sediment, but does not meet the bioaccumulation criteria set out in the Persistence and Bioaccumulation Regulations. It exhibits only a moderate to low potential for toxicity to aquatic organisms. On the basis of its relatively low ecological hazard, and the low concentrations measured in environmental media and effluents in Canada and elsewhere, it is concluded that methyl chloride 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.

Based on the available information on its potential to cause harm to human health, it is concluded that methyl chloride 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 included in the upcoming 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 methyl chloride does not meet any of the criteria set out in section 64 of CEPA 1999.

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

Whereas Phenol, 4-[[4-(phenylazo)phenyl]azo]- (Disperse Yellow 23), Phenol, 4-[[4-(phenylazo)-1-naphthalenyl]azo]- (Disperse Orange 13), Phenol, 2-methyl-4-[[4-(phenylazo)phenyl] azo]- (Disperse Yellow 7), Phenol, 4,4′-[1,4-phenylenebis(azo)] bis- (Disperse Yellow 68), and Phenol, 4-[[2-methoxy-4-[(2-methoxyphenyl)azo]-5-methylphenyl]azo]- are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the final Screening Assessment conducted on Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and Phenol, 4-[[2-methoxy-4-[(2-methoxyphenyl)azo]-5-methylphenyl]azo]- 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 Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and Phenol, 4-[[2-methoxy-4-[(2-methoxyphenyl)azo]-5-methylphenyl]azo]- above 100 kg per calendar year;

Whereas Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and Phenol, 4-[[2-methoxy-4-[(2-methoxyphenyl)azo]-5-methylphenyl]azo]- 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) of the Act thereof applies with respect to Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and Phenol, 4-[[2-methoxy-4-[(2-methoxyphenyl)azo]-5-methylphenyl]azo]-,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and Phenol, 4-[[2-methoxy-4-[(2-methoxyphenyl)azo]-5-methylphenyl]azo]- at this time under section 77 of the Act.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment on Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and Phenol, 4-[[2-methoxy-4-[(2-methoxyphenyl)azo]-5-methylphenyl]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 on the five disazo dyes (i.e. dyes with two azo groups) listed in Table 1. These substances were identified as high priorities for screening assessment and included in the Challenge because they were originally found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and were believed to be in commerce in Canada.

These five disazo dyes were 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 by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses primarily on information relevant to the evaluation of ecological risks.

Table 1. Disazo dyes included in this assessment

¹ Chemical Abstracts Service Registry Number

These five disazo dyes are organic substances that are used in Canada primarily as colourants — pigments, stains, dyes or inks. These substances are used primarily as textile dyes. They are not naturally produced in the environment. The five disazo dyes were not reported to be in Canadian commerce in amounts above the reporting threshold (100 kg) in either 2005 or 2006, based on information provided by industry in response to a notice published under section 71 of CEPA 1999. However, the threshold of 100 kg is used throughout this screening assessment to represent the highest potential quantity of each of these substances that could be in use below the reporting threshold.

Based on reported use patterns and certain assumptions related to dyes in general, it is expected that most of the disazo dyes would end up in waste disposal sites. A significant amount would, however, be estimated to be released to sewer water (14.8%). These five disazo dyes are not expected to be soluble in water or to be volatile, but are expected to adsorb on particles because of their hydrophobic nature. For these reasons and because they are heavier than water, after release to water the five disazo dyes would likely end up mostly in sediments. The five disazo dyes would not be expected to be significantly present in other media. They are also not expected to be subject to long-range atmospheric transport.

Based on their physical and chemical properties, the five disazo dyes are 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 these dyes have a low potential to accumulate in the lipid tissues of organisms. These substances therefore meet the persistence criteria but do not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for chemical analogues suggest that the five disazo dyes do not cause acute harm to aquatic organisms exposed at low concentrations.

For this screening assessment, a very conservative cumulative exposure scenario was selected in which a single wastewater treatment plant was assumed to discharge all five disazo dyes into the aquatic environment following primary sewage treatment. A conservative consumer release scenario was also developed. The predicted environmental concentrations in water were below the predicted no-effect concentration calculated for sensitive aquatic species for both scenarios.

It is concluded that Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and Phenol, 4-[[2-methoxy-4-[(2-methoxyphenyl)azo]-5-methylphenyl]azo]- are 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.

Some of the substances in this group of disperse disazo dyes have been subjected to controls in other jurisdictions, based on concern for their hazardous properties, including carcinogenicity. Although the likely high hazard of these dyes is recognized, on the basis of information which indicates that Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and Phenol, 4-[[2-methoxy-4-[(2-methoxyphenyl)azo]-5-methylphenyl] azo]- are not manufactured in or imported into Canada in amounts above the reporting threshold, the likelihood of exposure in Canada is considered to be low; hence the risk to human health is likewise considered to be low and it is concluded that they are substances that are not entering the environment in a quantity or concentration or under conditions that constitute a danger in Canada to human life or health.

Conclusion

Based on available information, it is concluded that Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and Phenol, 4-[[2-methoxy-4-[(2-methoxyphenyl)azo]-5-methylphenyl]azo]- 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 final Screening Assessment for these substances is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Whereas 2-Naphthalenol, 1-[(2-methoxyphenyl)azo]- (Solvent Red 1), 2-Naphthalenol, 1-[(2,4-dimethylphenyl)azo]- (Solvent Orange 7), and 1-Naphthalenol, 4-[(4-ethoxyphenyl)azo]- (Solvent Red 3) are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the final Screening Assessment conducted on Solvent Red 1, Solvent Orange 7 and Solvent Red 3 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 Solvent Red 1, Solvent Orange 7 and Solvent Red 3 above 100 kg per calendar year;

Whereas Solvent Red 1, Solvent Orange 7 and Solvent Red 3 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) of the Act thereof applies with respect to Solvent Red 1, Solvent Orange 7 and Solvent Red 3,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on Solvent Red 1, Solvent Orange 7 and Solvent Red 3 at this time under section 77 of the Act.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment of Solvent Red 1, Solvent Orange 7 and Solvent Red 3

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 on three monoazo solvent dyes, as follows:

• 2-Naphthalenol, 1-[(2-methoxyphenyl)azo]- (Solvent Red 1), Chemical Abstracts Service Registry No. 1229-55-6;
• 2-Naphthalenol, 1-[(2,4-dimethylphenyl)azo]- (Solvent Orange 7), Chemical Abstracts Service Registry No. 3118-97-6;
• 1-Naphthalenol, 4-[(4-ethoxyphenyl)azo]- (Solvent Red 3), Chemical Abstracts Service Registry No. 6535-42-8.

These three monoazo solvent dyes were identified as high priorities for screening assessment and included in the Challenge because they were originally found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and were believed to be in commerce in Canada.

These substances were not considered to be high priorities for assessment of potential risks to human health, based on application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List (DSL). Therefore, this assessment focuses primarily on information relevant to the evaluation of ecological risks.

These substances were previously used in Canada as colourant dyes — probably in textiles, fabric and paper based on use codes from the 1986 DSL. They are not naturally produced in the environment. No companies reported manufacturing, importing or using any of these substances in Canada above the reporting thresholds in 2006. In this assessment, the threshold of 100 kg was used to build scenarios and capture the potential quantity of these substances in use in Canada that would be below the threshold reporting value.

Based on certain assumptions and reported use patterns, when used, most of these substances are expected to end up in solid waste disposal sites and a significant proportion is estimated to be released to sewer water (17.4%). These three monoazo solvent dyes are not expected to be soluble in water; instead they are expected to partition to particles because of their hydrophobic nature. For these reasons, after release to water, these substances will likely end up mostly in sediments and, to a lesser extent, in agricultural soil that has been amended with sewage sludge. They are not expected to be volatile, hence not to be subject to long-range atmospheric transport.

Based on their physical and chemical properties, these three monoazo solvent dyes are expected to degrade slowly under aerobic conditions in the environment (in water, sediment and soil). Due to lack of experimental data relating to the bioaccumulation potential, a relatively close structural analogue of these three monoazo solvent dyes was used in the assessment and this resulted in the prediction that these substances have low potential to bioaccumulate in the environment. These substances are concluded to meet the persistence criteria but not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for chemical analogues suggest that these three monoazo solvent dyes do not cause acute harm to aquatic organisms exposed to low concentrations.

For this screening assessment, very conservative cumulative exposure scenarios were developed in which a single wastewater treatment plant was assumed to discharge these three monoazo solvent dyes after primary treatment into the aquatic environment. The predicted environmental concentrations in water were below the predicted no-effect concentration calculated for sensitive aquatic species.

It is concluded that Solvent Red 1, Solvent Orange 7 and Solvent Red 3 are 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.

Some of the substances in this group of monoazo dyes have been subjected to controls in other jurisdictions, based on concern for their hazardous properties, including carcinogenicity. Although the potential high hazard of Solvent Red 1, Solvent Orange 7 and Solvent Red 3 is recognized, on the basis of information which indicates that the substances are not manufactured in or imported into Canada in amounts above the reporting threshold, the likelihood of exposure in Canada is considered to be low; hence the risk to human health is likewise considered to be low and it is concluded that they are substances that are not entering the environment in a quantity or concentration or under conditions that constitute a danger in Canada to human life or health.

Conclusion

Based on available information, it is concluded that Solvent Red 1, Solvent Orange 7 and Solvent Red 3 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 final Screening Assessment for these substances is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Whereas 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4′[(2,4-diaminophenyl)azo][1,1′-biphenyl]-4-yl]azo]-5-hydroxy6-(phenylazo)-, disodium salt (Direct Black 38) 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 final Screening Assessment conducted on Direct Black 38 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 Direct Black 38 above 100 kg per calendar year;

Whereas Direct Black 38 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) of the Act thereof applies with respect to Direct Black 38,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on Direct Black 38 at this time under section 77 of the Act.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment of Direct Black 38

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 on 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4′-[(2,4-diaminophenyl) azo][1,1′-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt (Direct Black 38), Chemical Abstracts Service Registry No. 1937-37-7.

This substance was identified as a high priority for screening assessment and included in the Challenge because it was initially 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.

Direct Black 38 was not considered to be a high priority for assessment of potential risks to human health, based on 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 primarily on information relevant to the evaluation of ecological risks.

Direct Black 38 is a synthetic dye that is used as a colourant primarily in the textile industry. Direct Black 38 is typical of other direct dyes in that it exhibits a high affinity for cellulose fibres. Other applications include dyeing paper, leather, plastics, inks and wood. This chemical is not naturally produced in the environment. In industry surveys conducted pursuant to section 71 of CEPA 1999, no companies reported manufacturing, importing or using Direct Black 38 in Canada above the reporting thresholds in 2005 or 2006. Therefore, reporting thresholds are used throughout this screening assessment as a conservative estimate of the quantity of this substance in commerce in Canada.

Based on reported use patterns and certain assumptions related to dyes in general, potential releases of Direct Black 38 to the Canadian environment during the formulation and consumer use of products containing this substance are estimated to be 15% to sewers and 85% transferred to waste disposal sites. Direct Black 38 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 sewage treatment as a result of such substances being adsorbed to sludge.

Information on other disulfonated acid dyes, as well as results of quantitative structure-activity relationship (QSAR) modelling, indicates that Direct Black 38 will persist in aerobic environments (water, soil, sediment). Degradation of Direct Black 38 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), indicates that it has a low potential to accumulate in the lipid tissues of organisms. Therefore, Direct Black 38 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 Direct Black 38 and other disulfonated acid dyes suggest that this substance is not expected to cause acute harm to aquatic organisms at low concentrations.

For this screening assessment, a conservative exposure scenario in which an industrial operation discharges this substance into the aquatic environment through a single sewage treatment plant was selected. While there were no reports of Direct Black 38 being in commerce, the reporting threshold of 100 kg was used to conservatively estimate release and exposure levels. The predicted environmental concentration in water of this substance was below the predicted no-effect concentration for sensitive aquatic organisms, resulting in a risk quotient of much lower than one.

It is concluded that Direct Black 38 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.

Direct Black 38 has been subjected to controls in other jurisdictions, based on concern about its hazardous properties, including carcinogenicity. Although the likely high hazard of Direct Black 38 is recognized, on the basis of information which indicates that it is not manufactured in or imported into Canada in amounts above the reporting threshold, the likelihood of exposure in Canada is considered to be low; hence the risk to human health is likewise considered to be low and it is concluded that it is a substance that is not entering the environment in a quantity or concentration or under conditions that constitute a danger in Canada to human life or health.

Conclusion

Based on available information, it is concluded that Direct Black 38 does not meet any of the criteria set out in section 64 of CEPA 1999.

Because this substance is listed on the Domestic Substances List, its import and manufacture in Canada are not subject to notification under subsection 81(1). Given the hazardous properties 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 the substance so that new manufacture, import or use of this substance be subject to notification and undergo ecological and human health risk assessments.

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