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Vol. 143, No. 22 — May 30, 2009
DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after Screening
Assessment of Substances — Batch 6
CAS No. 100-44-7
CAS No. 74-87-3
CAS No. 19800-42-1
CAS No. 85-86-9
CAS No. 6250-23-3
CAS No. 6253-10-7
CAS No. 6300-37-4
CAS No. 21811-64-3
CAS No. 93805-00-6
CAS No. 1229-55-6
CAS No. 3118-97-6
CAS No. 6535-42-8
CAS No. 1937-37-7
CAS No. 6358-57-2
CAS No. 7147-42-4
Publication of Results of Investigations and
Recommendations for Substances
CAS No. 68515-42-4
CAS No. 107-05-1
CAS No. 117-82-8
Publication after screening assessment of a substance — Benzene, (chloromethyl)- (benzyl chloride), CAS No. 100-44-7 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas 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 draft Screening Assessment Report conducted on benzyl chloride pursuant to section 74 of the Act is annexed hereby; and
Whereas it is proposed to conclude that 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 have released a risk management scope document for this substance to initiate discussions with stakeholders on the development of a risk management approach.
Public comment period
As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www. chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 1-800-410-4314 or 819-953-4936 (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.
GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY
Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD
Director General
Chemicals, Air and Water Directorate
On behalf of the Minister of Health
ANNEX
Summary of the Screening Assessment Report 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. The focus of this assessment relates primarily to human health aspects.
According to data submitted in response to section 71 of CEPA 1999, no companies 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 or 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 is also prevalent in the atmospheric emissions from coal- and oil-fired power plants. The principal route of exposure 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 proposed 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.
Based on the information available, it is proposed 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. Benzyl chloride meets the criterion for persistence in air but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.
This substance will be included in the upcoming DSL inventory update initiative. Where relevant, research and monitoring will support verification of assumptions used during the screening assessment.
Proposed conclusion
Based on the information available, it is proposed to conclude that benzyl chloride meets one or more of the criteria set out in section 64 of CEPA 1999.
The draft Screening Assessment Report as well as the proposed risk management scope document for this substance are 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 — 1,2-Benzenedicarboxylic acid, di-C 7-11 -branched and linear alkyl esters (DHNUP), CAS No. 68515-42-4 — specified on the Domestic Substances List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)
Whereas DHNUP 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 a screening assessment conducted on DHNUP pursuant to paragraph 68(b) of the Canadian Environmental Protection Act, 1999 is annexed hereby; and
Whereas it is proposed to conclude that DHNUP 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 DHNUP be added to Schedule 1 to the Act.
Notice is furthermore given that the Ministers of the Environment and of Health have released a risk management scope document for this substance to initiate discussions with stakeholders on the development of a risk management approach.
Public comment period
Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 1-800-410-4314 or 819-953-4936 (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.
GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY
Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD
Director General
Chemicals, Air and Water Directorate
On behalf of the Minister of Health
ANNEX
Summary of the Screening Assessment on 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters
The Ministers of the Environment and of Health have conducted a screening assessment of 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters (DHNUP), Chemical Abstracts Service Registry No. 68515-42-4. This substance was identified in the categorization of the Domestic Substances List (DSL) 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 of 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 was estimated to be completely phased out in Canada subsequent to the 2006 reporting year, whereas annual importation activity was estimated to have declined by over 95%. Phaseout 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 plasticization of electrical and communication wire insulation.
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.
In this screening assessment, exposure scenarios were developed to estimate releases into the aquatic environment from industrial operations and resulting aquatic concentrations. At three industrial sites, the obtained predicted environmental concentrations in water exceeded the predicted no-effect concentrations for sensitive aquatic organisms. This indicates that the substance may cause ecological harm in the aquatic environment. The Government is interested in obtaining additional information on current industrial handling practices for DHNUP, including those associated with management of bulk transport container residues.
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 proposed 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 proposed that DHNUP is entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. 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 DSL inventory update initiative. Where relevant, research and monitoring will support verification of assumptions used during the screening assessment.
Proposed conclusion
Based on the information available, it is proposed to conclude that DHNUP meets one or more of the criteria set out in section 64 of CEPA 1999.
The draft Screening Assessment Report as well as the proposed risk management scope document for this substance are 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 — 1-Propene-3-chloro- (3-Chloropropene), CAS No. 107-05-1 — specified on the Domestic Substances List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)
Whereas 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 an investigation 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 it is proposed to conclude that 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.
Public comment period
Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 1-800-410-4314 or 819-953-4936 (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.
GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY
Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD
Director General
Chemicals, Air and Water Directorate
On behalf of the Minister of Health
ANNEX
Summary of the Screening Assessment Report 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 of 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 the 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 for 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. Exposures from other media are 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 incidences were observed in dermally exposed mice 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 deaths due to cancer in 3-chloropropene-exposed workers. Thus, in light of the only weak evidence of carcinogenicity, characterization of risk to human health was based on information on non-cancer effects.
Exposure to 3-chloropropene has also 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 and conservatively modelled estimates of exposure via inhalation during use of some personal care products that contain 3-chloropropene, and with 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 proposed 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 exposure concentrations. On the basis of its relatively low ecological hazard, the low concentrations measured historically in Canadian surface water and effluents and the low quantity currently in commerce in Canada, it is proposed 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.
Proposed conclusion
Based on available information, and until new information is received indicating that this substance is entering, or may enter the environment, it is proposed to conclude that the above substance is currently not entering, nor is it likely to enter, the environment as a result of commercial activity in Canada. Therefore, it is proposed to conclude that it does not meet any of the criteria set out in section 64 of CEPA 1999.
As a substance listed on the DSL, import and manufacture of this substance in Canada are not subject to notification under subsection 81(1) of the Act. Given the hazardous properties of this substance, there is concern that new activities for the above substance which have not been identified or assessed could lead to the substance meeting the criteria set out in section 64 of the Act. Therefore, it is recommended that the above substance be subject to the Significant New Activity provisions specified under subsection 81(3) of the Act, to ensure that any new manufacture, import or use of the substance in quantities greater than 100 kg/year is notified and will undergo ecological and human health risk assessments as specified in section 83 of the Act, prior to the substance being introduced into Canada.
The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).
Publication of results of investigations and recommendations for a substance — 1,2-Benzenedicarboxylic acid, bis(2-methoxyethyl) ester (DMEP), CAS No. 117-82-8 — specified on the Domestic Substances List — (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)
Whereas DMEP 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 an investigation conducted on DMEP 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 DMEP above 100 kg per calendar year;
Whereas it is proposed to conclude that DMEP 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 DMEP,
Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on DMEP at this time.
Public comment period
Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 1-800-410-4314 or 819-953-4936 (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.
GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY
Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD
Director General
Chemicals, Air and Water Directorate
On behalf of the 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.
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 proposed 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.
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 proposed 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.
Proposed conclusion
Based on available information, and until new information is received indicating that this substance is entering, or may enter the environment, it is proposed to conclude that the above substance is currently not entering, nor is it likely to enter, the environment as a result of commercial activity in Canada. Therefore, it is proposed to conclude that it does not meet any of the criteria set out in section 64 of CEPA 1999.
As DMEP is listed on the DSL, its import and manufacture in Canada are not subject to notification under subsection 81(1) of the Act. Given the hazardous properties of this substance, there is concern that new activities that have not been identified or assessed could lead to DMEP meeting the criteria set out in section 64 of the Act. Therefore, it is proposed that DMEP be subjected to the Significant New Activity provisions specified under subsection 81(3) of the Act, to ensure that new manufacture, import or use of DMEP is notified and will undergo ecological and human health risk assessments, as specified in section 83 of the Act, prior to its introduction into Canada.
The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).
Publication after screening assessment of a substance — Methane, chloro- (Methyl chloride), CAS No. 74-87-3 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas 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 draft Screening Assessment Report conducted on methyl chloride pursuant to section 74 of the Act is annexed hereby; and
Whereas it is proposed to conclude that 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.
Public comment period
As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www. chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 1-800-410-4314 or 819-953-4936 (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.
GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY
Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD
Director General
Chemicals, Air and Water Directorate
On behalf of the 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 to human health risks.
Based on empirical and modelled data for persistence in air, water, soil and sediment, methyl chloride is expected to be persistent in the environment. However, experimental and modelled data indicate that this substance does not have a high potential to accumulate in the environment. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.
According to information provided by Statistics Canada, 1 049 000 kg of methyl chloride were imported into Canada in 2006.
The most important industrial use of methyl chloride is 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, the 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 inhalation bioassay in rodents the number of renal tumours was 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 kidneys 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.
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.
Proposed conclusion
Based on the information available, it is proposed to conclude that methyl chloride does not meet any of the criteria set out in section 64 of CEPA 1999.
The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).
Publication after screening assessment of seven substances — Phenol, 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]- (Disperse Orange 29), CAS No. 19800-42-1; 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]- (Solvent Red 23), CAS No. 85-86-9; Phenol, 4-[[4-(phenylazo)phenyl]azo]- (Disperse Yellow 23), CAS No. 6250-23-3; Phenol, 4-[[4-(phenylazo)-1-naphthalenyl]azo]- (Disperse Orange 13), CAS No. 6253-10-7; Phenol, 2-methyl-4-[[4-(phenylazo)phenyl]azo]- (Disperse Yellow 7), CAS No. 6300-37-4; Phenol, 4,4 ′ -[1,4-phenylenebis(azo)]bis- (Disperse Yellow 68), CAS No. 21811-64-3 and Phenol, 4-[[2-methoxy-4-[(2-methoxyphenyl)azo]-5-methylphenyl]azo]- (MMMP), CAS No. 93805-00-6 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas Disperse Orange 29, Solvent Red 23, Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and MMMP are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the draft Screening Assessment Report conducted on Disperse Orange 29, Solvent Red 23, Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and MMMP pursuant to section 74 of the Act is annexed hereby; and
Whereas it is proposed to conclude that Disperse Orange 29, Solvent Red 23, Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and MMMP do 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 Disperse Orange 29, Solvent Red 23, Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and MMMP at this time under section 77 of the Act.
Public comment period
As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www. chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 1-800-410-4314 or 819-953-4936 (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.
GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY
Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD
Director General
Chemicals, Air and Water Directorate
On behalf of the Minister of Health
ANNEX
Summary of the Screening Assessment on Disperse Orange 29, Solvent Red 23, Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and MMMP
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 seven disazo dyes (i.e. dyes with two azo groups) listed in Table 1. These substances were identified as high priorities for screening assessment and were 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 seven 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 (DSL). Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.
Table 1. Disazo dyes included in this assessment
|
Domestic Substances List Name |
CAS RN1 |
|---|---|
|
Phenol, 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]- |
19800-42-1 |
|
2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]- |
85-86-9 |
|
Phenol, 4-[[4-(phenylazo)phenyl]azo]- |
6250-23-3 |
|
Phenol, 4-[[4-(phenylazo)-1-naphthalenyl]azo]- |
6253-10-7 |
|
Phenol, 2-methyl-4-[[4-(phenylazo)phenyl]azo]- |
6300-37-4 |
|
Phenol, 4,4′-[1,4-phenylenebis(azo)]bis- |
21811-64-3 |
|
Phenol, 4-[[2-methoxy-4-[(2-methoxyphenyl)azo]-5-methylphenyl]azo]- |
93805-00-6 |
|
1 Chemical Abstracts Service Registry Number |
These seven disazo dyes are organic substances that are used in Canada primarily as colourants — pigments, stains, dyes or inks. Six of these substances are used primarily as textile dyes, but Solvent Red 23 (85-86-9) is used primarily in oils, fats and waxes, but also in alcoholic, ester and hydrocarbon solvents, in polystyrene, in cosmetics and as an indicator. It is also used as a pesticide colourant. The seven disazo dyes are not naturally produced in the environment. None are reported to be manufactured in Canada; however, between 1 000 and 10 000 kg of two of these dyes (19800-42-1 and 85-86-9) were imported into the country in 2005 and 2006, either in products or for use in the manufacturing of various coloured products. The other 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 Canada’s notices of intent. However, the threshold of 100 kg is used throughout this screening assessment to represent the highest potential quantity of these substances that could be in use below the reporting threshold.
Based on reported use patterns in Canada and certain assumptions, it is expected that most of the disazo dyes which are used in Canada would end up in waste disposal sites. A significant amount would, however, be estimated to be released to sewer water (14.8%). These seven disazo dyes are not expected to be soluble in water or volatile, but are expected to adsorb on particles because of their hydrophobic nature. For these reasons and because these dyes are heavier than water, after release to water they will likely end up mostly in sediments, and possibly to a much lesser extent in agricultural soil that has been amended with sewage sludge. In addition, between 100 kg and 1 000 kg per year of Solvent Red 23 may be released to air and soil, as a component of an agricultural pesticide. The seven disazo dyes are not 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 seven disazo dyes are expected to be persistent in soil 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 seven 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 seven disazo dyes (including 6250-23-3, 6253-10-7, 6300-37-4, 21811-64-3 and 93805-00-6, which are not reported to be in Canadian commerce above the 100 kg threshold) after primary treatment into the aquatic environment. The predicted environmental concentration in water was below predicted no-effect concentrations calculated for sensitive aquatic species.
These substances will be included in the upcoming DSL inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.
Proposed conclusion
Based on the information available, it is proposed to conclude that Disperse Orange 29, Solvent Red 23, Disperse Yellow 23, Disperse Orange 13, Disperse Yellow 7, Disperse Yellow 68 and MMMP do not meet any of the criteria set out in section 64 of CEPA 1999.
The draft Screening Assessment Report for these substances is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).
Publication after screening assessment of three substances — 2-Naphthalenol, 1-[(2-methoxyphenyl)azo]- (Solvent Red 1), CAS No. 1229-55-6; 2-Naphthalenol, 1-[(2,4-dimethylphenyl)azo]- (Solvent Orange 7), CAS No. 3118-97-6 and 1-Naphthalenol, 4-[(4-ethoxyphenyl)azo]- (Solvent Red 3), CAS No. 6535-42-8 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas Solvent Red 1, Solvent Orange 7 and 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 draft Screening Assessment Report conducted on Solvent Red 1, Solvent Orange 7 and Solvent Red 3 pursuant to section 74 of the Act is annexed hereby; and
Whereas it is proposed to conclude that 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,
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.
Public comment period
As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www. chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 1-800-410-4314 or 819-953-4936 (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.
GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY
Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD
Director General
Chemicals, Air and Water Directorate
On behalf of the Minister of Health
ANNEX
Summary of the Screening Assessment on 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; and
— 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 a high priority 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 are believed to be in commerce in Canada.
These substances were not considered to be a high priority for assessment of potential risks to human health, based upon 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 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. However the threshold of 100 kg was used throughout this screening assessment to capture the highest 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 or to be volatile; 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 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, 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 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 a chemical analogue suggest that these three monoazo solvent dyes do not cause acute harm to aquatic organisms exposed to low concentrations.
For this screening assessment, a very conservative cumulative exposure scenario was 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 concentration in water was below predicted no-effect concentrations calculated for sensitive aquatic species.
These substances will be included in the upcoming DSL inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.
Proposed conclusion
Based on the information available, it is proposed to conclude that 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.
The draft Screening Assessment Report for these substances is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).
Publication after screening assessment of two substances — 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), CAS No. 1937-37-7 and 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(1) of the Canadian Environmental Protection Act, 1999)
Whereas Direct Black 38 and Acid Red 111 are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the draft Screening Assessment Report conducted on Direct Black 38 and Acid Red 111 pursuant to section 74 of the Act is annexed hereby; and
Whereas it is proposed to conclude that Direct Black 38 and Acid Red 111 do 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 Direct Black 38 and Acid Red 111 at this time under section 77 of the Act.
Public comment period
As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www. chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 1-800-410-4314 or 819-953-4936 (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.
GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY
Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD
Director General
Chemicals, Air and Water Directorate
On behalf of the Minister of Health
ANNEX
Summary of the Screening Assessment Report of Direct Black 38 and Acid Red 111
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 following two substances:
— 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; and
— 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), Chemical Abstracts Service Registry No. 6358-57-2.
These substances were identified as a high priority for screening assessment and included in the Challenge because they were initially found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms.
Neither Direct Black 38 nor Acid Red 111 were 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 (DSL). Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.
Direct Black 38 and Acid Red 111 are synthetic dye colourants that are used 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 paper, leather, plastics, inks, wood (Direct Black 38 and Acid Red 111) and paints (Acid Red 111). These chemicals are not naturally produced in the environment. However, no companies reported manufacturing, importing or using Direct Black 38 in Canada above the reporting thresholds in 2005 or 2006. With respect to Acid Red 111, companies reported the import of between 100 and 1 000 kg of this substance into Canada in 2005 and 2006.
These substances are azo dyes with two sulfonic acid groups that impart high water solubility to these substances. Given that dyes have an inherently high affinity to substrates, a large proportion is generally removed during sewage treatment as a result of the substances being adsorbed to sludge.
Information on selected analogue acid dyes (i.e. also disulfonated), as well as results of QSAR modelling, suggest that Direct Black 38 and Acid Red 111 would be present in aerobic environments as chemically stable substances and thus they would generally be expected to persist in the environment. Degradation of Direct Black 38 and 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 metabolites being formed as a result of cleavage of their azo bonds. However, in these situations exposure to aquatic organisms would be limited. The high water solubility of these substances, as well as other physical and chemical properties (e.g. large molecular size), suggest that they likely have a low potential to accumulate in the lipid tissues of organisms. These substances are persistent but not bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations.
Based on reported use patterns and certain assumptions, releases of these dyes to the Canadian environment during the formulation and consumer use of products containing these substances are estimated to be 14.6% (all of which goes to sewers), while 85.4% of the quantity in commerce is expected to be transferred to waste disposal sites. For this screening assessment, a conservative exposure scenario was selected in which an industrial operation discharges both of these substances into the aquatic environment through a single sewage treatment plant. The combined predicted environmental concentration in water of these substances was 0.03 mg/L. This concentration was below the predicted no-effect concentration for sensitive aquatic organisms, resulting in a risk quotient of much lower than 1.
These substances will be included in the DSL inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.
Proposed conclusion
Based on the information available, it is proposed to conclude that Direct Black 38 and Acid Red 111 do not meet the criteria set out in section 64 of CEPA 1999.
The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).
Publication after screening assessment of a substance — Butanamide, 2,2′-[(3,3′-dimethoxy[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxo-(BPAOPB), CAS No. 7147-42-4 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas BPAOPB is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the draft Screening Assessment Report conducted on BPAOPB pursuant to section 74 of the Act is annexed hereby; and
Whereas it is proposed to conclude that BPAOPB 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 BPAOPB at this time under section 77 of the Act.
Public comment period
As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www. chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 1-800-410-4314 or 819-953-4936 (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.
GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY
Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD
Director General
Chemicals, Air and Water Directorate
On behalf of the Minister of Health
ANNEX
Summary of the Screening Assessment Report of Butanamide, 2,2′-[(3,3′-dimethoxy[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis [N-(2-methylphenyl)-3-oxo-
Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Butanamide, 2,2′-[(3,3′-dimethoxy[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis [N-(2-methylphenyl)-3-oxo- (BPAOPB), Chemical Abstracts Service Registry No. 7147-42-4. This substance was identified as a high priority for screening assessment and included in the Challenge because it was initially 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 by Health Canada for categorization of substances on the Domestic Substances List (DSL). Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.
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. The substance is not naturally produced in the environment. Fewer than four companies reported manufacturing between 100 and 1 000 kg of BPAOPB in Canada in 2006, while no imports or uses were reported for that year.
Based on reported use patterns and certain assumptions, releases of BPAOPB to the Canadian environment resulting from its manufacture are estimated to be 0.1% to air and 4% to sewers. It is estimated that 2% is transferred to waste disposal sites. There are no experimental data available on the physical and chemical properties of this substance. Given the data available for other pigments identified as 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 will likely be found in sediments if released to surface waters, and will tend to remain in soils if released to terrestrial environments.
Modelled data suggest that little degradation of this substance would occur in the environment. Model-generated bioaccumulation estimates that are based on experimental data for the solubility in octanol and water of pigments identified as analogues, as well as the fact that BPAOPB is a very large molecule, suggest that this pigment likely has a low potential to accumulate in the lipid tissues of organisms. Therefore, BPAOPB is persistent but not bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for other pigments identified as analogues suggest that saturated solutions of the substance do not cause acute harm to aquatic organisms.
For this screening assessment, a conservative exposure scenario was selected in which an industrial operation discharges BPAOPB into the aquatic environment. The predicted environmental concentration in water (0.006 mg/L) was below the predicted no-effect concentration for sensitive aquatic organisms (0.76 mg/L), resulting in a risk quotient of much lower than 1.
This substance will be included in the DSL inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.
Proposed conclusion
Based on the information available, it is proposed to conclude that BPAOPB does not meet any of the criteria set out in section 64 of CEPA 1999.
The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).
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