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Vol. 144, No. 12 — March 20, 2010

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after Screening Assessment of Substances — Batch 9

CAS No. 1314-62-1
CAS No. 7758-01-2
CAS No. 7328-97-4
CAS No. 71032-95-6
CAS No. 475-71-8
CAS No. 1326-05-2
CAS No. 14295-43-3
CAS No. 38465-55-3
CAS No. 58161-93-6
CAS No. 509-34-2
CAS No. 2134-15-8
CAS No. 2379-74-0
CAS No. 41556-26-7
CAS No. 64338-16-5
CAS No. 1309-64-4

Publication of Results of Investigations and Recommendations for Substances

CAS No. 93-15-2
CAS No. 88-12-0

Publication after screening assessment of a substanceVanadium oxide, CAS No. 1314-62-1 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

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

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

Whereas it is proposed to conclude that vanadium oxide 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 vanadium oxide 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, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

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

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

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

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

ANNEX

Summary of the Screening Assessment of Vanadium Oxide

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 vanadium oxide, Chemical Abstracts Service Registry No. 1314-62-1. This substance was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. Vanadium oxide was identified as a high priority as it was considered to pose “greatest potential for exposure” of individuals in Canada and had been classified by the International Agency for Research on Cancer on the basis of carcinogenicity and by the European Commission on the basis of genotoxicity and developmental toxicity. The substance also met the ecological categorization criteria for persistence and inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of vanadium oxide relates to both environmental and human health risks.

According to information submitted under section 71 of CEPA 1999, between 1 000 000 and 10 000 000 kg of vanadium oxide was incidentally produced in Canada in the 2006 calendar year. Some importation activities were reported at a total quantity of between 1 000 000 and 10 000 000 kg in 2006. Between 100 000 to 1 000 000 kg of vanadium oxide was used in 2006.

Measurements of vanadium in environmental media (ambient air, drinking water, surface water and sediment) and food in Canada and elsewhere capture total vanadium, including vanadium oxide. Vanadium is naturally occurring in the environment. In Canada, the major uses of vanadium oxide are in the manufacture of ferrovanadium and as a catalyst in the production of sulphuric acid, for catalytic cracking application, and for catalytic reduction of nitrogen oxide and sulphur emissions from power plants. The major anthropogenic sources of vanadium oxide are the burning of certain fossil fuels and the emissions from oil refineries produced during catalytic processing of oil.

Based principally on the weight-of-evidence-based assessments of international or other national agencies, a critical effect for characterization of risk to human health for vanadium oxide is carcinogenicity. Increased incidences of lung tumours were observed in male and female mice and in male rats following inhalation exposure. Genotoxicity was observed in both in vivo and in vitro assays with vanadium oxide in mammalian cells. Based on lung tumours observed in rats and mice for which modes of induction have not been fully elucidated, it cannot be precluded that vanadium oxide induces tumours via a mode of action involving direct interaction with genetic material.

Repeated-dose studies with vanadium oxide based on oral exposure showed effects in the spleen, liver, kidney and lung as well as on the immune system of rats.

On the basis of the carcinogenic potential of vanadium oxide, for which there may be a probability of harm at any level of exposure, it is proposed to conclude that vanadium oxide 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.

The releases of vanadium oxide into the Canadian environment are due mainly to atmospheric emissions from various industrial activities, in particular fossil fuel combustion. Deposition of vanadium oxide to surrounding terrestrial and aquatic ecosystems then occurs. Because vanadium oxide is soluble, it will dissolve in contact with moisture once in these ecosystems and will yield a variety of dissolved vanadium species depending on the environmental conditions. Vanadium has been demonstrated to have a moderate to high acute and chronic toxicity to aquatic organisms, and a low chronic toxicity to terrestrial organisms.

Site-specific industrial scenarios based on monitoring data were developed for the most important sources of releases of vanadium oxide to the environment. Based on risk quotient analyses, harm to aquatic and terrestrial organisms resulting from exposure to vanadium oxide is unlikely. Hence, it is proposed to conclude that the substance is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. Vanadium oxide does meet the criteria for persistence but does not meet the criteria for bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations.

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

Proposed conclusion

Based on the information available, it is proposed to conclude that vanadium oxide meets one or more of the criteria set out in section 64 of CEPA 1999.

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

Publication after screening assessment of a substancePotassium bromate, CAS No. 7758-01-2 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

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

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

Whereas it is proposed to conclude that potassium bromate 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 potassium bromate 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, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

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

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

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

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

ANNEX

Summary of the Screening Assessment of Potassium Bromate

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 potassium bromate, Chemical Abstracts Service Registry No. 7758-01-2. The substance potassium bromate was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. Potassium bromate was identified as a high priority as it was considered to pose intermediate potential for exposure of individuals in Canada and is classified by other agencies on the basis of carcinogenicity. This substance met the ecological categorization criteria for persistence and inherent toxicity to aquatic organisms, but not for bioaccumulation potential. This assessment focuses principally on information relevant to the evaluation of risks to human health.

According to information reported under section 71 of CEPA 1999, less than 1 000 kg of potassium bromate was imported into Canada in 2006. No Canadian companies reported manufacturing potassium bromate in 2006 and it was not released into the environment in 2006. In Canada, potassium bromate is used in primarily industrial and non-consumer applications.

Based on available information from various sources and results from a survey under section 71 of CEPA 1999, exposure to the general population to potassium bromate in environmental media (e.g. drinking water) and in consumer products is considered to be negligible.

As potassium bromate was classified on the basis of carcinogenicity by international regulatory agencies, carcinogenicity was a key focus for this screening assessment. Kidney tumours, mesotheliomas (testes and peritoneal), and thyroid tumours were all observed after administration of potassium bromate in drinking water. No evidence was available to suggest a carcinogenic potential for potassium bromate via the inhalation or dermal routes. Data from a wide range of genotoxicity studies suggests that potassium bromate is genotoxic in vitro and in vivo. Although the mode of induction of tumours has not been fully elucidated, based on the genotoxicity of potassium bromate, it cannot be precluded that potassium bromate induces tumours via a mode of action involving direct interaction with genetic material.

Exposure to potassium bromate has also been associated with a variety of non-cancer effects in experimental animals. These include reproductive and immunological effects, as well as non-neoplastic effects in the kidney, thyroid, testes, and pituitary gland. Since exposure to potassium bromate is expected to be low and the most sensitive non-cancer effects occurred at a dose level at which pre-neoplastic lesions and tumours were also observed, margins of exposures were not calculated for non-cancer effects.

On the basis of the carcinogenic potential of potassium bromate, for which there may be a probability of harm at any exposure level, it is proposed to conclude that potassium bromate 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 (relatively low quantity in commerce, moderate aquatic toxicity), it is proposed to conclude that potassium bromate 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. Potassium bromate meets the criteria for persistence in water but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

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

Proposed conclusion

Based on the information available, it is proposed to conclude that potassium bromate meets one or more of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment as well as the proposed risk management scope document 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 Benzene, 1,2-dimethoxy-4-(2-propenyl)- (Methyl eugenol), CAS No. 93-15-2 — specified on the Domestic Substances List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Whereas Benzene, 1,2-dimethoxy-4-(2-propenyl)- (also known as methyl eugenol) is a substance identified as high priority for action under the Challenge, published in the Canada Gazette, Part I, on December 9, 2006;

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

Whereas it is proposed to conclude that methyl eugenol 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 methyl eugenol 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, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

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

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

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

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

ANNEX

Summary of the Screening Assessment on Benzene, 1,2-dimethoxy-4-(2-propenyl)-

The Ministers of the Environment and of Health have conducted a screening assessment of Benzene, 1,2-dimethoxy-4(2-propenyl)- (commonly called methyl eugenol), Chemical Abstracts Service Registry No. 93-15-2. Methyl eugenol was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. Methyl eugenol was identified as a high priority as it was considered to pose an intermediate potential for exposure of individuals in Canada and it had been classified by the United States National Toxicology Program on the basis of carcinogenicity. This substance was not considered to be a high priority for assessment of potential risks to the environment as it did not meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to aquatic organisms. Therefore, the assessment focuses principally on information relevant to the evaluation of human health.

Methyl eugenol is an organic substance and is naturally occurring in the essential oils of several plant species. These oils are extracted for use principally as flavour ingredients in food and beverages and as fragrance ingredients and emollients in personal care products. It is a component of a citronella oil-based personal insect repellent registered for use in Canada. Based on information reported pursuant to section 71 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), it was not reported to be manufactured in Canada in 2006, and there was less than 100 kg of the substance imported into the country in the same calendar year.

Methyl eugenol is considered ubiquitous in air and water at very low concentrations. The predominant source of exposure to the general population is expected to result from its naturally occurring presence in food and beverages, with smaller contributions from the use of personal care products and citronella oil-based personal insect repellents.

Based principally on the weight-of-evidence-based assessments of international or other national agencies, a critical effect for the characterization of risk to human health for methyl eugenol is carcinogenicity. In the standard two-year carcinogenicity studies with rats and mice, methyl eugenol induced multiple types of tumours in both males and females in a dose-related manner. Of note, the significantly increased incidences of liver tumours were observed at the lowest dose tested in both rats and mice in the chronic studies. Methyl eugenol was genotoxic in a range of in vivo and in vitro assays, although it was not mutagenic in bacterial cells. Methyl eugenol bound to liver DNA and formed DNA adducts in vivo and in vitro. In addition, methyl eugenol caused gene mutation in the liver of transgenic animals and induced mutation of β-catenin gene in mouse liver tumours. While the mode of induction of tumours has not been fully elucidated, based on genotoxicity of methyl eugenol, it cannot be precluded that methyl eugenol induces tumours via a mode of action involving direct interaction with genetic material.

Methyl eugenol is also associated with non-cancer effects in experimental animals including cytologic alteration, necrosis, hyperplasia, atrophy, organ or body weight changes in rats and mice. The critical non-cancer effect was reduced body weight or body weight gain. With respect to non-cancer effects, comparison of the critical effect level with upper-bounding estimates of exposure to the general population from presence of methyl eugenol in use of personal care products and citronella oil-based personal insect repellents results in margins of exposure that are considered adequate.

On the basis of the carcinogenic potential of methyl eugenol, for which there may be a probability of harm at any exposure level, it is proposed to conclude that methyl eugenol 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 its physical and chemical properties and limited experimental data, methyl eugenol does not meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, both experimental and modelled toxicity data suggest that the substance is only moderately hazardous to aquatic organisms. Given the low quantity in commerce in Canada, the environmental concentration is predicted to be well below the predicted no effect concentration. On the basis of ecological hazard of methyl eugenol, it is proposed to conclude 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.

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

Proposed conclusion

Based on the information available, it is proposed to conclude that Benzene, 1,2-dimethoxy-4-(2-propenyl)- meets one or more of the criteria set out in section 64 of CEPA 1999.

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

Publication after screening assessment of a substanceOxirane, 2,2′,2″,2″′-[1,2-ethanediylidenetetrakis(4,1-phenyleneoxymethylene)]tetrakis-, CAS No. 7328-97-4 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Oxirane, 2,2′,2″,2″′-[1,2-ethanediylidenetetrakis(4,1-phenyleneoxymethylene)]tetrakis- is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on Oxirane, 2,2′,2″,2″′-[1,2-ethanediylidenetetrakis(4,1-phenyleneoxymethylene)]tetrakis- pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Oxirane, 2,2′,2″,2″′-[1,2-ethanediylidenetetrakis(4,1-phenyleneoxymethylene)]tetrakis- 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 Oxirane, 2,2′,2″,2″′-[1,2-ethanediylidenetetrakis(4,1-phenyleneoxymethylene)]tetrakis- 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, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

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

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

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

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

ANNEX

Summary of the Screening Assessment Report of Oxirane, 2,2′,2″,2″′-[1,2-ethanediylidenetetrakis (4,1-phenyleneoxymethylene)]tetrakis-

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 Oxirane, 2,2′,2″,2″′-[1,2-ethanediylidenetetrakis(4,1-phenyleneoxymethyl-ene)]tetrakis- (TGOPE), Chemical Abstracts Service Registry No. 7328-97-4. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

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

The substance TGOPE is a solid epoxy resin that is used in Canada and elsewhere primarily in the manufacture of paints, coatings and adhesives. The substance is not naturally occurring in the environment. It is not reported to be manufactured in Canada; however, between 1 000 and 10 000 kg were imported into the country in 2006.

The potential for exposure of the general population to TGOPE from environmental media is expected to be negligible. There is no expected exposure from food. Exposure to TGOPE from consumer products may occur during use of epoxy adhesives; however, such exposure is expected to be very low. Therefore, exposure of the general population in Canada is expected to be low to negligible.

During the manufacturing process of items containing TGOPE, virtually all of the TGOPE will chemically react and therefore become chemically transformed and unavailable for release. The very small amount of unreacted TGOPE remaining in manufactured items is assumed to be disposed of in landfill sites. About 1.6% of the mass of TGOPE reported to be sold in Canada is estimated to be released to water during industrial processing, 1% is disposed of in landfills in waste products, and no releases are predicted to air and soil. TGOPE has low predicted water solubility (0.06 mg/L). It is essentially non-volatile. It will partition to sediments (57%) if released to surface waters and will remain in soil if released to soil.

Based on its physical and chemical properties and on data from a chemical analogue, TGOPE is not considered to be persistent in the environment, as it is predicted to hydrolyze in water. Modelled bioaccumulation data that take into account metabolic transformation suggest that this substance has a high potential to accumulate in the lipid tissues of organisms. The hydrolysis product of TGOPE is predicted to have a low potential to bioaccumulate but is expected to persist in the environment. Considering the hydrolysis of TGOPE to a transformation product with different characteristics, it does not meet the persistence criteria but does meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

Experimental toxicity data for a chemical analogue suggest that saturated solutions of TGOPE cause acute and chronic harm to aquatic organisms. The hydrolysis product of TGOPE is predicted to have low toxicity to aquatic organisms.

For this screening assessment, a conservative site-specific exposure scenario was selected in which an industrial operation discharges TGOPE into the aquatic environment. The predicted environmental concentration in water was below the predicted no-effect concentration for pelagic aquatic organisms.

With regard to human health, while limited toxicity data for TGOPE were identified, the genotoxicity assays identified for TGOPE indicate mutagenic potential in vitro. In addition, structural analogues of TGOPE were found to have carcinogenic potential in experimental animals and direct-acting mutagenic potential in a range of in vitro essays and mixed results in vivo assays. Therefore, given the positive results for genotoxicity of TGOPE, and the collective evidence from genotoxicity and carcinogenicity data for the analogues of TGOPE, it is considered that TGOPE may cause harm at any level of exposure.

On the basis of the carcinogenic potential of TGOPE, for which there may be a probability of harm at any level of exposure, it is proposed to conclude that TGOPE 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 to conclude that TGOPE 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. TGOPE does not meet the persistence criteria but does meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

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

Proposed conclusion

Based on the information available, it is proposed to conclude that Oxirane, 2,2′,2″,2″′-[1,2-ethanediylidenetetrakis (4,1-phenyleneoxymethylene)]tetrakis- meets one or more of the criteria set out in section 64 of CEPA 1999.

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

Publication after screening assessment of a substance2-Naphthalenesulfonic acid, 7-[[4,6-bis[[3-(diethylamino) propyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3[[4-(phenylazo)phenyl]azo]-, monoacetate (salt), CAS No. 71032-95-6 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 2-Naphthalenesulfonic acid, 7-[[4,6-bis[[3-(diethylamino)propyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy3-[[4-(phenylazo)phenyl]azo]-, monoacetate (salt) is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on 2-Naphthalenesulfonic acid, 7-[[4,6-bis[[3-(diethylamino)propyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy3-[[4-(phenylazo)phenyl]azo]-, monoacetate (salt) pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that 2-Naphthalenesulfonic acid, 7-[[4,6-bis[[3-(diethylamino)propyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-(phenylazo)phenyl]azo]-, monoacetate (salt) 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 2-Naphthalenesulfonic acid, 7-[[4,6-bis[[3-(diethylamino)propyl]amino]-1,3,5-triazin-2-yl] amino]-4-hydroxy-3-[[4-(phenylazo)phenyl]azo]-, monoacetate (salt) 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, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

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

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

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

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

ANNEX

Summary of the Screening Assessment Report of 2-Naphthalenesulfonic acid, 7-[[4,6-bis[[3-(diethylamino) propyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-(phenylazo)phenyl]azo]-, monoacetate (salt)

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on 2-Naphthalenesulfonic acid, 7-[[4,6-bis[[3-(diethylamino)propyl] amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-(phenylazo) phenyl]azo]-, monoacetate (salt) [NDTHPM], Chemical Abstracts Service Registry No. 71032-95-6. This substance was identified as a high priority for screening assessment and included in the Challenge because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

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

The substance NDTHPM is a synthetic cationic direct (azo) dye that is used as a colourant primarily for paper. The substance does not naturally occur in the environment. As a result of an industry survey conducted pursuant to section 71 of CEPA 1999, no companies reported manufacturing or using NDTHPM in Canada above reporting thresholds in 2006. However, data that were submitted confirmed that this substance was imported into Canada in a total quantity between 100 and 1 000 kg in both 2005 and 2006. The quantity of NDTHPM imported into Canada, along with its intended use, indicate that it could be released into the Canadian environment.

Based on reported use patterns and certain assumptions related to dyes in general, a large proportion of the substance is predicted to end up in landfills or be incinerated (~37%). Approximately 11% is estimated to be released to wastewater, while the remaining mass (~52%) is estimated to be transferred to recycling activities. The substance NDTHPM is anticipated to be highly soluble in water, based on data for a structural analogue. However, given the positive and negative charges that exist on the molecule in solution (pH 6–9),like other ionic dyes, it will have an affinity for solid particles due to electrostatic interactions. Thus, it may settle in bed sediments to some degree and if present in soil, will tend to remain there.

Predicted data suggest that NDTHPM will persist in aerobic environments (water, soil and sediment). Degradation of azo dyes 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’s structural analogue, as well as other physical and chemical properties (e.g. low experimental log Dow, charged nature, large molecular size), suggests that NDTHPM has a low potential to accumulate in the lipid tissues of organisms. Therefore, this substance meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental acute and chronic aquatic toxicity values for NDTHPM and a structural analogue indicate that this substance is not expected to cause acute harm to aquatic organisms at low concentrations.

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

The potential for exposure of the general population to NDTHPM from environmental media is expected to be negligible. There is no expected exposure to NDTHPM from food. Exposure to NDTHPM from consumer products (e.g. non-food paper products containing NDTHPM dye) is expected to be negligible by dermal route of exposure and low for incidental events such as mouthing by toddlers. No empirical health effects information was identified for NDTHPM; however, given the known genotoxicity and carcinogenicity of the potential azo cleavage product (4-aminoazobenzene), it is proposed to conclude that NDTHPM is a substance for which there may be a probability of harm at any level of exposure. Therefore, based on the information available, it is proposed to conclude that NDTHPM 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 to conclude that NDTHPM is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. The substance NDTHPM meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

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

Proposed conclusion

Based on the information available, it is proposed to conclude that 2-Naphthalenesulfonic acid, 7-[[4,6-bis[[3-(diethylamino)propyl] amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-(phenylazo) phenyl]azo]-, monoacetate (salt) meets one or more of the criteria set out in section 64 of CEPA 1999.

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

Publication after screening assessment of five substances — Benzo[h]benz[5,6]acridino[2,1,9,8-klmna]acridine-8,16-dione, CAS No. 475-71-8; Spiro[isobenzofuran-1(3H),9′-[9H]xanthen]-3-one, 2′,4′,5′,7′-tetrabromo-3′,6′-dihydroxy-, lead salt, CAS No. 1326-05-2; Benzo[b]thiophen-3(2H)-one, 4,7-dichloro-2-(4,7-dichloro-3-oxobenzo[b]thien-2(3H)-ylidene)-, CAS No. 14295-43-3; Nickel, bis[1-[4-(dimethylamino)phenyl]-2-phenyl-1,2-ethenedithiolato(2-)-S,S']-, CAS No. 38465-55-3 and Benzoic acid, 4-[1-[[(2,4-dichlorophenyl)amino]carbonyl]-3,3-dimethyl-2-oxobutoxy]-, CAS No. 58161-93-6 specified on the Domestic Substances List (subsection 77(1)of the Canadian Environmental Protection Act, 1999)

Whereas substances benzo[h]benz[5,6]acridino[2,1,9,8-klmna] acridine-8,16-dione; spiro[isobenzofuran-1(3H),9′-[9H]xanthen]-3-one, 2′,4′,5′,7′-tetrabromo-3′,6′-dihydroxy-, lead salt; benzo[b] thiophen-3(2H)-one, 4,7-dichloro-2-(4,7-dichloro-3-oxobenzo[b] thien-2(3H)-ylidene)-; nickel, bis[1-[4-(dimethylamino)phenyl]-2-phenyl-1,2-ethenedithiolato(2-)-S,S']- and benzoic acid, 4-[1-[[(2,4-dichlorophenyl)amino]carbonyl]-3,3-dimethyl-2-oxobutoxy]- are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

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

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

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

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

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

Public comment period

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

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

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

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

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

ANNEX

Summary of the Draft Screening Assessment of the Five Substances Listed Below

CAS RN*

DSL Name

475-71-8

Benzo[h]benz[5,6]acridino[2,1,9,8-klmna]acridine-8,16-dione

1326-05-2

Spiro[isobenzofuran-1(3H),9′-[9H]xanthen]-3-one, 2′,4′,5′,7′-tetrabromo-3′,6′-dihydroxy-, lead salt

14295-43-3

Benzo[b]thiophen-3(2H)-one, 4,7-dichloro-2-(4,7-dichloro3-oxobenzo
[b]thien-2(3H)-ylidene)-

38465-55-3

Nickel, bis[1-[4-(dimethylamino)phenyl]-2-phenyl-1,2-ethenedithiolato(2-)-S,S']-

58161-93-6

Benzoic acid, 4-[1-[[(2,4-dichlorophenyl)amino]carbonyl]3,3-dimethyl-
2-oxobutoxy]-

*CAS RN = Chemical Abstracts Service Registry Number

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

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

Results from notices issued under paragraph 71(1)(b) of CEPA 1999 in March 2009 revealed no reports of industrial activity (import or manufacture) with respect to these substances in Canada, equal or above the reporting threshold of 100 kg, for the 2006 reporting year. These results suggest that these substances are currently not in use above the specified reporting threshold, and therefore the likelihood of exposure to these substances in Canada resulting from commercial activity is low.

Information received as a result of the above notices issued under paragraph 71(1)(b) of CEPA 1999 and the accompanying questionnaire of March 2009 also revealed no significant new data relevant to the PBiT properties of these five substances. Given the lack of any significant commercial activity for these substances, no additional efforts have been made to collect or analyze information relevant to the persistence, bioaccumulation and ecological effects of these five substances beyond what was done for categorization. Therefore, the decisions on PBiT properties made during categorization remain unchanged. The substances are considered to be highly hazardous to non-human organisms. They also meet the criteria for both persistence and bioaccumulation as set out in the Persistence and Bioaccumulation Regulations.

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

Proposed conclusion

Based on available information, it is proposed to conclude that benzo[h]benz[5,6]acridino[2,1,9,8-klmna]acridine-8,16-dione; spiro [isobenzofuran-1(3H),9′-[9H]xanthen]-3-one, 2′,4′,5′,7′-tetrabromo-3′,6′-dihydroxy-, lead salt; benzo[b]thiophen-3(2H)-one, 4,7-dichloro-2-(4,7-dichloro-3-oxobenzo[b]thien-2(3H)-ylidene)-; nickel, bis[1-[4-(dimethylamino)phenyl]-2-phenyl-1, 2-ethenedithiolato(2-)-S,S']- and benzoic acid, 4-[1-[[(2,4-dichlorophenyl)amino]carbonyl]-3,3-dimethyl-2-oxobutoxy]- 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 is subject to notification and undergo ecological and human health risk assessments. In addition and where relevant, research and monitoring will support verification of assumptions used during this screening assessment.

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

Publication after screening assessment of a substanceSpiro[isobenzofuran-1(3H),9′-[9H]xanthen]-3-one, 3′,6′-bis(diethylamino)- (Solvent Red 49), CAS No. 509-34-2 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Spiro[isobenzofuran-1(3H),9′-[9H]xanthen]-3-one, 3′,6′-bis(diethylamino)- (also known as Solvent Red 49) is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on Solvent Red 49 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 49 above 100 kg per calendar year;

Whereas it is proposed to conclude that Solvent Red 49 does not meet any of the criteria set out in section 64 of the Act; and

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

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on Solvent Red 49 at this time under section 77 of the Act.

Public comment period

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

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

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

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

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

ANNEX

Summary of the Screening Assessment of Spiro[isobenzofuran-1(3H),9′-[9H]xanthen]-3-one, 3′,6′-bis(diethylamino)-

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 Spiro[isobenzofuran-1(3H),9′-[9H]xanthen]-3-one, 3′,6′-bis(diethylamino)- (Solvent Red 49), Chemical Abstracts Service Registry No. 509-34-2. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance Solvent Red 49 was not considered to be a high priority for assessment of potential risks to human health, based on the application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses principally on information relevant to the evaluation of ecological risks.

In 2006, no companies reported importing or manufacturing the substance above the reporting threshold of 100 kg/year. No company reported using the substance above the reporting threshold of 1 000 kg/year in 2006; however, five companies reported a stakeholder interest in Solvent Red 49.

Since there were no reports of use, import or manufacture of Solvent Red 49 in Canada in 2006 at or above the reporting thresholds specified in the notice published under section 71 of CEPA 1999, releases of this substance to the Canadian environment are expected to be very low. As a conservative measure, it was assumed that 100 kg/year were used in both industrial and consumer use scenarios.

Solvent Red 49 shows high modelled water solubilities and a low octanol-water partitioning coefficient. It is present in the environment primarily as a zwitterion (i.e. both positive and negative charges present) that is not volatile, is rather chemically stable, and is expected to have a tendency to partition to sediments if released to surface waters, and adsorb to soils if released to land. This behaviour is mainly governed by electrostatic interactions.

Based on its physical and chemical properties, Solvent Red 49 is expected to be persistent in water, soil and sediment. However, new experimental data relating to its solubility in octanol and water and empirical bioaccumulation data for a chemical analogue suggest that this dye has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, new experimental toxicity data for a chemical analogue, as well as new toxicity predictions that take into account revised estimates of bioaccumulation potential, suggest that the substance is likely to have only a moderate potential for toxicity to aquatic organisms.

For this screening assessment, two very conservative exposure scenarios were considered involving both industrial use and consumer use, which would result in discharges of Solvent Red 49 into the aquatic environment. The highest predicted environmental concentration in water, which was for the industrial use scenario, was more than two orders of magnitude below the predicted no-effect concentration calculated for sensitive aquatic biota.

Although the potential hazard to human health is recognized for Solvent Red 49, there were no reports of use, import or manufacture of Solvent Red 49 in Canada in 2006 at or above the reporting thresholds specified in the notice published under section 71 of CEPA 1999. The likelihood of exposure to the general population is therefore low; hence, the risk to human health is likewise considered to be low. Therefore, it is proposed to conclude that Solvent Red 49 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.

Based on the information available, it is proposed to conclude that Solvent Red 49 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. Solvent Red 49 meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

Proposed conclusion

Based on available information, it is proposed to conclude that Spiro[isobenzofuran-1(3H),9′-[9H]xanthen]-3-one, 3′,6′-bis(diethylamino)- 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 the substance meeting the criteria set out in section 64 of the Act. Therefore, it is recommended to amend the Domestic Substances List, under subsection 87(3) of the Act, to indicate that subsection 81(3) of the Act applies with respect to this substance so that new manufacture, import or use of the substance is subject to notification and undergo ecological and human health risk assessments. In addition and where relevant, research and monitoring will support verification of assumptions used during this screening assessment.

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

Publication after screening assessment of a substanceBenzoic acid, 2,3,4,5-tetrachloro-6-(2,4,5,7-tetrabromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)- (Solvent Red 48), CAS No. 2134-15-8 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Benzoic acid, 2,3,4,5-tetrachloro-6-(2,4,5,7-tetrabromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)- (also known as Solvent Red 48) is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on Solvent Red 48 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Solvent Red 48 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 Solvent Red 48 at this time under section 77 of the Act.

Public comment period

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

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

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

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

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

ANNEX

Summary of the Screening Assessment Report of Benzoic acid, 2,3,4,5-tetrachloro-6-(2,4,5,7-tetrabromo6-hydroxy-3-oxo-3H-xanthen-9-yl)-

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 Benzoic acid 2,3,4,5-tetrachloro-6-(2,4,5,7-tetrabromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)- (Solvent Red 48), Chemical Abstracts Service Registry No. 2134-15-8. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance Solvent Red 48 was not considered to be a high priority for assessment of potential risks to human health, based on the application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Solvent Red 48 is an organic substance that may be used as a dye in Canada in various applications including in personal-care products and in drugs. Based on the survey conducted under section 71 of CEPA 1999, no companies reported importing or manufacturing the substance above the reporting threshold of 100 kg/year, and no use of the substance was reported above the reporting threshold of 1 000 kg/year in 2006. However, two companies reported a stakeholder interest in Solvent Red 48.

Since there was no reporting of use, import or manufacture of Solvent Red 48 in Canada in 2006 at or above the reporting thresholds specified in the notice published under section 71 of CEPA 1999, releases of this substance to the Canadian environment are expected to be very low. As a conservative measure, it was assumed that 100 kg per year were used in both industrial and consumer use scenarios.

Based on available information, including a survey under section 71 of CEPA 1999, exposure of the general population to Solvent Red 48 from environmental media (ambient and indoor air, drinking water, soil, and sediment) is expected to be negligible. The general population of Canada may be exposed to Solvent Red 48 from use of certain cosmetics, including some personal care products, as it is an ingredient in some products on the Canadian market.

Solvent Red 48 is expected to have a high water solubility and a low octanol-water distribution coefficient. It would be present in the environment primarily as a di-anion that is not volatile, is rather chemically stable, and is expected to have a tendency to partition to sediments if released to surface waters, and to remain in soils if released to land. This behaviour is mainly governed by electrostatic interactions.

Based on its physical and chemical properties, Solvent Red 48 is expected to be persistent in water, soil and sediment. With its relatively large molecular size and weight and low octanol-water distribution coefficient, modelled results suggest that this substance is not bioaccumulative. The substance therefore meets the criteria for persistence in water, soil and sediment, but does not meet the criteria for bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations. In addition, newly identified experimental toxicity data for a chemical analogue, as well as new toxicity predictions that take into account revised estimates of bioaccumulation potential, suggest that the substance is likely to have a moderate to high potential for toxicity to sensitive aquatic organisms.

For this screening assessment, two very conservative exposure scenarios were considered involving both industrial use and consumer use, which result in discharges of Solvent Red 48 into the aquatic environment. The highest predicted environmental concentration in water, which was for the industrial use scenario, was almost two orders of magnitude below the predicted no-effect concentration calculated for sensitive aquatic biota.

Solvent Red 48 was not identified as posing a high hazard to human health. Based on consideration of the hazard profile of Solvent Red 48, upper-bounding estimates of exposure to cosmetics, including some personal care products containing this substance, and toxicokinetics of the substance, a concern for human health was not identified.

Based on the information available, it is proposed to conclude that Solvent Red 48 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 to conclude that Solvent Red 48 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. Solvent Red 48 meets the criteria for persistence, but does not meet the criteria for bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations.

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

Proposed conclusion

Based on the information available, it is proposed to conclude that Benzoic acid, 2,3,4,5-tetrachloro-6-(2,4,5,7-tetrabromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)- does not meet any of the criteria set out in section 64 of CEPA 1999.

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

Publication after screening assessment of a substanceBenzo[b]thiophen-3(2H)-one, 6-chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methyl- (Pigment Red 181), CAS No. 2379-74-0 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Benzo[b]thiophen-3(2H)-one, 6-chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methyl- (also known as Pigment Red 181) is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on Pigment Red 181 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Pigment Red 181 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 Pigment Red 181 at this time under section 77 of the Act.

Public comment period

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

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

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

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

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

ANNEX

Summary of the Screening Assessment of Benzo[b]thiophen-3(2H)-one, 6-chloro-2-(6-chloro-4-methyl-3oxobenzo[b]thien-2(3H)-ylidene)-4-methyl-

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 Benzo[b]thiophen-3(2H)-one, 6-chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methyl-, Chemical Abstracts Service Registry No. 2379-74-0. This substance, also known as Pigment Red 181, was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance Pigment Red 181 was not considered to be a high priority for assessment of potential risks to human health, based on the application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses principally on information relevant to the evaluation of ecological risks.

Pigment Red 181 is a special-purpose pigment for polystyrene and similar polymers. It is also used in personal care products. The substance does not naturally occur in the environment. It is not reported to be manufactured in Canada; however, between 100 and 1 000 kg of the pigment were imported into the country in 2006, both as an industrial chemical and in imported coloured products.

Based on reported use patterns in Canada and on certain assumptions, most of the substance is exported from Canada in finished products, and the portion that remains in Canada is believed to be released ultimately to wastewater either during the manufacture of coloured items or after consumer use of such items. There are no releases predicted to air and soil. Pigment Red 181 presents very low experimental solubilities in water and low solubility in octanol. It is present in the environment primarily as micro-particulate matter that is not volatile and is relatively chemically stable, and it has a tendency to partition by gravity to sediments if released to surface waters, and to soils if released to terrestrial environments.

Based on its physical and chemical properties, Pigment Red 181 is expected to be persistent in water, soil and sediment. New experimental data relating to its solubility in octanol and water suggest that this pigment has a low potential to accumulate in the lipid tissues of organisms. The substance meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, new toxicity predictions that take into account revised estimates of bioaccumulation potential suggest that saturated solutions of the substance do not cause acute harm to aquatic organisms.

For this screening assessment, two conservative exposure scenarios were used. In one scenario, an industrial operation (user of the pigment) discharges Pigment Red 181 into the aquatic environment. In the second scenario, use of Pigment Red 181 in cosmetics by consumers results in the release of the substance to the aquatic environment. In both scenarios, the predicted environmental concentration in water was below predicted no-effect concentrations calculated for sensitive aquatic organisms.

Based on available information, and a survey under section 71 of CEPA 1999, exposure of the general population to Pigment Red 181 from environmental media (ambient and indoor air, drinking water, soil and sediment) is expected to be negligible. The general population of Canada may be exposed to Pigment Red 181 from use of cosmetics, including some personal care products, as it is an ingredient in some products on the Canadian market.

Pigment Red 181 was not identified as posing a high hazard to human health. Based on consideration of the hazard profile of Pigment Red 181 and upper-bounding estimates of exposure to cosmetics, including some personal care products containing this substance, and toxicokinetics of the substance, a concern for human health was not identified.

Based on the information available, it is proposed to conclude that Pigment Red 181 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 to conclude that Pigment Red 181 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. Pigment Red 181 meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

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

Proposed conclusion

Based on the information available, it is proposed to conclude that Benzo[b]thiophen-3(2H)-one, 6-chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methyl- does not meet any of the criteria set out in section 64 of CEPA 1999.

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

Publication after screening assessment of a substanceDecanedioic acid, bis(1,2,2,6,6-pentamethyl-4-piperidinyl) ester, CAS No. 41556-26-7 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Decanedioic acid, bis(1,2,2,6,6-pentamethyl4-piperidinyl) ester is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on Decanedioic acid, bis(1,2,2,6,6-pentamethyl4-piperidinyl) ester pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Decanedioic acid, bis(1,2,2,6,6-pentamethyl-4-piperidinyl) ester 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 Decanedioic acid, bis(1,2,2,6,6-pentamethyl-4-piperidinyl) ester at this time under section 77 of the Act.

Public comment period

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

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

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

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

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

ANNEX

Summary of the Screening Assessment Report of Decanedioic acid, bis(1,2,2,6,6-pentamethyl-4-piperidinyl) ester

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Decanedioic acid, bis(1,2,2,6,6-pentamethyl-4-piperidinyl) ester (PEDA), Chemical Abstracts Service Registry No. 41556-26-7. This substance was identified as a high priority for screening assessment and included in the Challenge because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

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

The substance PEDA is an organic substance that is used in Canada and elsewhere in paint and coatings for automobiles, as a component of polymers and as a photosensitive agent. Although the products are not intended to be used by the general population, the following consumer products were identified in the Canadian consumer market as containing PEDA: automobile interior protectants, waterborne semi-transparent stain products, aerosol solvent-borne paints and sealants.

The substance does not naturally occur in the environment. A total of 54 202 kg of PEDA was imported into Canada and 9 541 kg were used in 2006. The quantity of PEDA imported into Canada, along with the potentially dispersive uses of this substance, indicate that it could be released into the Canadian environment.

Based on reported use patterns and certain assumptions, the majority of the substance ends up in waste disposal sites (71.7%) with a lesser amount going to recycling (15.1%). Smaller proportions are estimated to be lost to wastewater (6.2%), paved/ unpaved land surfaces (3.8%), incineration (2.2%) and export (1%).

The substance protonates in water completely, such that the only form present in water is the positively charged form. The primary dissociation constant of the substance (pKa1 = 10.03; base form) indicates that there is complete protonation of the substance at ambient pHs (6–9). Therefore, as PEDA will exist predominantly as charged species in water at environmentally relevant pHs, being present as a protonated cation, the assessment was made on the cation, recognizing that the conclusion of persistence, bioaccumulation and toxicity are based on the cation.

Based on experimental and modelled physical and chemical properties, the charged form of the substance is moderately soluble in water, is non-volatile and is unlikely to partition in significant amounts to particles and lipids (fat) of organisms because of its charged nature and large molecular size. For these reasons, PEDA will be found mostly in water and in soil, depending upon the medium to which it is released. It is not expected to be significantly present in other media.

Based on an atmospheric oxidation half-life of 0.067 days, PEDA is expected to rapidly oxidize in air. Model results indicate that PEDA may undergo relatively rapid primary biodegradation in air, but biodegradation modelling results indicate that in both water and soil, as well as in sediments, the ultimate biodegradation half-life of PEDA is likely to be greater than 182 days and 365 days respectively. It is, therefore, persistent in water, soil and sediments. PEDA was initially categorized as bioaccumulative based on model predictions for the neutral ion; however, recent measured and modelling results that take into consideration the presence of the charged form of the compound indicate that PEDA does not have the potential to accumulate to a significant extent in aquatic organisms or biomagnify in trophic food chains. The substance has therefore been determined to meet the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

Empirical acute toxicity data indicate that PEDA has the potential to cause adverse effects to aquatic organisms at relatively low concentrations. However, no empirical chronic effects data were available for this substance. Modelled chronic data (esters) based on results that take into account the charged character of the substance, suggest that PEDA is moderately to highly toxic to aquatic organisms.

For this screening assessment, two very conservative exposure scenarios were selected to predict the environmental concentrations of PEDA in Canada; one to predict the potential industrial emissions of the substance to the aquatic environment, and the other to quantify the level of aquatic exposure to a substance released from consumer products. Risk quotient analysis comparing the predicted environmental concentration (PEC) associated with industrial releases with a predicted no-effect concentration (PNEC) resulted in a risk quotient value of 0.02 to 0.46. The PEC for the consumer release was below the PNEC calculated for sensitive aquatic life. These results suggest that releases of PEDA are not likely to be harming the aquatic environment.

With regard to human health, no measured concentrations of PEDA in environmental media were identified in Canada or elsewhere. No information with regards to the presence of PEDA in foods was identified. Exposure of the Canadian population to this substance from environmental media is expected to be negligible according to estimates based on the quantity of PEDA in Canadian commerce in 2006. Exposures to PEDA resulting from its use in food packaging applications are expected to be negligible. Estimates of exposure to PEDA from its use in consumer products were derived.

Limited empirical data related to health effects were available for PEDA. The quantitative structure-activity relationship model predictions for carcinogenicity, genotoxicity, reproductive and developmental toxicity were mixed. Information on analogues of PEDA indicates potential effects on the liver and nervous system in experimental animals.

Based on the information available, the margins of exposure between upper-bounding estimates of exposure from use of consumer products and levels associated with effects in experimental animals observed in studies with analogues of PEDA are considered to be adequately protective.

Given the information presented in this draft screening assessment, it is proposed to conclude that PEDA 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.

Therefore, it is proposed to conclude that PEDA 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 information available, PEDA meets the criteria for persistence but does not meet the criteria for bioaccumulation as set out in the Persistence and Bioaccumulation Regulations.

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

Proposed conclusion

Based on the information available, it is proposed to conclude that Decanedioic acid, bis(1,2,2,6,6-pentamethyl-4-piperidinyl) ester does not meet any of the criteria set out in section 64 of CEPA 1999.

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

Publication after screening assessment of a substance7-Oxa-3,20-diazadispiro[5.1.11.2]heneicosan-21-one, 2,2,4,4-tetramethyl-, CAS No. 64338-16-5 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 7-Oxa-3,20-diazadispiro[5.1.11.2]heneicosan-21-one, 2,2,4,4-tetramethyl- is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on 7-Oxa-3,20-diazadispiro[5.1.11.2]heneicosan-21-one, 2,2,4,4-tetramethyl- pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that 7-Oxa-3,20-diazadispiro[5.1.11.2]heneicosan-21-one, 2,2,4,4-tetramethyl- 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 7-Oxa-3,20-diazadispiro[5.1.11.2]heneicosan-21-one, 2,2,4,4-tetramethyl- at this time under section 77 of the Act.

Public comment period

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

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

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

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

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

ANNEX

Summary of the Screening Assessment Report of 7-Oxa-3,20-diazadispiro[5.1.11.2]heneicosan-21-one, 2,2,4,4-tetramethyl-

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 7-Oxa-3,20-diazadispiro[5.1.11.2]heneicosan-21-one, 2,2,4,4-tetramethyl- (ODHO), Chemical Abstracts Service Registry No. 64338-16-5. This substance was identified as a high priority for screening assessment and included in the Challenge because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

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

The substance ODHO is an organic substance that is used to protect plastic polymers and industrial materials from photochemical degradation. The substance does not occur naturally in the environment. Surveys conducted under section 71 of CEPA 1999 determined that, in 2005 and 2006, ODHO was not manufactured in Canada in quantities equal to or greater than 100 kg; however, in both years, imports of the substance into Canada were in the range of 100–1 000 kg/year.

A predicted acid dissociation constant (pKa) value of greater than 9 for the amine suggests that ODHO will exist almost entirely as a charged molecule in the environmentally relevant pH range of 6 to 9, with the substance existing primarily as a protonated cation and acting as a weak base. Therefore, when released to the environment, ODHO is expected to partition predominantly into water, although partitioning to soil, and to a lesser extent sediment, may also occur depending on the compartment of release.

With a predicted atmospheric oxidation half-life of 0.11 day, ODHO is expected to be rapidly oxidized in air. Biodegradation modelling predicts that ODHO in water, soil and sediment will undergo primary biodegradation in less than 182 days, but the identities of the degradation products are not known. However, ultimate biodegradation modelling indicates that complete mineralization will occur only slowly, and the substance and/or its degradation products may therefore persist in water, soil and sediment. Based on the available data, ODHO meets the persistence criteria in water, soil and sediment (half-lives in soil and water ≥ 182 days and half-life in sediment ≥ 365 days), but does not meet the criterion for air (half-life criterion of ≥ 2 days) as set out in the Persistence and Bioaccumulation Regulations.

The substance ODHO was initially categorized as potentially bioaccumulative based on model predictions for the neutral compound. However, given the evidence for molecular charge at ambient pHs (6–9), as well as a new measured bioconcentration factor of about 4.0 and new predicted bioaccumulation and bioconcentration factors (BAF/BCF) ranging from 12.8 to 1 580 that take into account the fact that the charged form is expected to predominate, it is considered unlikely that ODHO will accumulate in large amounts in organisms. Therefore, it is considered not to meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

Empirical data suggest that ODHO has a moderate to low potential for acute toxicity in aquatic organisms. However, no empirical data are available on possible effects following long-term exposure, an issue of importance given the evidence for stability of the substance in the environment. For this reason, predicted data were also considered in evaluating the potential for toxicity. The results suggest that ODHO will generally have moderate toxicity to aquatic organisms and that the charged form that is likely to predominate at environmental pH 6 to 9 will be less toxic than the neutral compound. However, a lowest chronic toxicity estimate of 0.3 mg/L for the charged form to algae is considered to indicate that ODHO may have the potential to cause adverse effects following long-term exposure of aquatic organisms to relatively low concentrations in the environment.

The substance ODHO meets the criteria for persistence and is predicted to be potentially harmful to sensitive aquatic species exposed for long periods at low concentrations. However, the substance is considered to have low exposure potential based on relatively low import volumes and information indicating that when added to plastics and coatings during processing operations, it becomes chemically reacted into the matrix material thereby reducing the potential for release into the environment from finished products.

A risk quotient analysis, integrating a conservative predicted environmental concentration (PEC) with a conservative predicted no-effect concentration (PNEC) resulted in a risk quotient (PEC/PNEC) value of 0.4, indicating that current estimated exposure concentrations of ODHO in water are unlikely to cause ecological harm at the current and foreseeable level of use in Canada.

With regard to human health, no measured concentrations of ODHO in environmental media were identified in Canada and elsewhere. However, the potential for exposure of the general population to ODHO from environmental media is expected to be negligible according to estimates based on the quantity of ODHO in Canadian commerce in 2006. No information with regard to the presence of ODHO in foods was identified. Exposure from food, if any, would be negligible. No consumer products were identified in Canada that contain ODHO.

There are very limited toxicological data available for ODHO, and quantitative structure activity relationship (QSAR) programs for carcinogenicity, genotoxicity, and reproductive and developmental toxicity did not generate predictions in most cases. The confidence in the toxicity database is considered to be low due to the limited available data for ODHO or its analogues.

Since exposure of the general population to ODHO in Canada is expected to be negligible, and since ODHO was not identified as posing a high hazard to human health based on the limited information available, it is proposed to conclude that ODHO 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.

It is further proposed to conclude that ODHO 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. ODHO meets the criteria for persistence but does not meet the criteria for bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations.

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

Proposed conclusion

Based on the information available, it is proposed to conclude that 7-Oxa-3,20-diazadispiro[5.1.11.2]heneicosan-21-one, 2,2,4,4-tetramethyl- does not meet any of the criteria set out in section 64 of CEPA 1999.

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

Publication of results of investigations and recommendations for a substance 2-Pyrrolidinone, 1-ethenyl-, CAS No. 88-12-0 — specified on the Domestic Substances List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Whereas 2-Pyrrolidinone, 1-ethenyl-is a substance identified as high priority for action under the Challenge, published in the Canada Gazette, Part I, on December 9, 2006;

Whereas the summary of the draft Screening Assessment conducted on 2-Pyrrolidinone, 1-ethenyl- pursuant to paragraph 68(b) of the Canadian Environmental Protection Act, 1999 is annexed hereby; and

Whereas it is proposed to conclude that 2-Pyrrolidinone, 1-ethenyl- 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 2-Pyrrolidinone, 1-ethenyl- at this time.

Public comment period

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

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

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

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

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

ANNEX

Summary of the Screening Assessment on 2-Pyrrolidinone, 1-ethenyl-

The Ministers of the Environment and of Health have conducted a screening assessment of 2-Pyrrolidone, 1-ethenyl- (1-vinyl-2-pyrrolidone, abbreviated as NVP), Chemical Abstracts Service Registry No. 88-12-0. The substance NVP was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. NVP was identified as a high priority as it was classified by the European Commission on the basis of carcinogenicity. The substance did not meet the ecological categorization criteria for persistence, bioaccumulation potential or inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of NVP relates primarily to human health risks.

According to information submitted under section 71 of CEPA 1999, NVP was not manufactured by any company in Canada in the calendar year 2006 above the 100 kg reporting threshold. However, approximately 10 000–100 000 kg of the substance was imported in 2006. The major use of NVP is the industrial manufacturing of NVP-derived polymers, with the principal source of exposure of the general population thought to be through personal care products.

NVP-derived polymers are used in the personal care products industry. The polymers function as thickeners, dispersing agents and binders in cosmetics, and as a stiffener in hair grooming products. Polymerized NVP has many uses in the pharmaceutical industry. The polymer is used as a binding agent for tablets and in film coatings of capsules to aid ingestion. NVP-derived polymers function as stabilizers for enzymes and heat-sensitive drugs as well as crystallization inhibitors in liquid medications. Industrial uses of NVP include the manufacturing of UV curable inks and coatings. NVP is used as a formulant in 11 pesticides registered for commercial use in Canada.

As NVP was classified on the basis of carcinogenicity by other national and international agencies, carcinogenicity was a key focus for this screening assessment. In a chronic carcinogenicity study, rats exposed to NVP by inhalation showed dose-related increased incidences of hepatocellular carcinoma and nasal cavity adenomas and adenocarcinomas as well as increases in squamous carcinomas of the larynx at the highest dose tested. Neoplastic changes were also seen in female rats exposed to NVP by inhalation for 3 months followed by 21 months of recovery. However, no long-term study investigating exposure to NVP in other species or via the oral or dermal routes of exposures was identified. Consideration of the available information regarding genotoxicity and the conclusions of other agencies indicate that NVP is not likely to be mutagenic. Accordingly, a threshold approach is used to assess risk to human health.

Non-neoplastic effects based on inhalation exposure in repeated-dose studies were observed at the same critical effect level as the neoplastic effects, and the liver and respiratory tract of rats and mice were identified as the target organs. The margin between upper-bounding estimates of exposure from acute and chronic exposure to personal care products and the critical effect level is considered to be adequately protective to account for data gaps and uncertainties in the human health assessment for both cancer and non-cancer effects.

Chronic exposure to NVP from pharmaceuticals is lower than exposure to NVP from personal care (cosmetic) products.

Based on the available information on the potential to cause harm to human health and the resulting margins of exposure, it is proposed to conclude that NVP is a substance that is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

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

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

Proposed conclusion

Based on the information available, it is proposed to conclude that 2-Pyrrolidinone, 1-ethenyl- does not meet any of the criteria set out in section 64 of CEPA 1999.

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

Publication after screening assessment of a substance— Antimony oxide, CAS No. 1309-64-4 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

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

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

Whereas it is proposed to conclude that antimony oxide 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 antimony oxide at this time under section 77 of the Act.

Public comment period

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

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

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

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

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

ANNEX

Summary of the Screening Assessment of Antimony Oxide

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 antimony oxide, Chemical Abstracts Service Registry No. 1309-64-4. The substance antimony oxide was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. Antimony oxide was identified as a high priority as it was considered to pose “greatest potential for exposure” of individuals in Canada and is classified by other agencies on the basis of carcinogenicity; in addition, this substance met the ecological categorization criteria for persistence. The focus of this assessment of antimony oxide relates to both human health and ecological risks.

According to information reported under section 71 of CEPA 1999, between 1 000 000 and 10 000 000 kg of antimony oxide were manufactured in Canada in 2006. In addition, Canadian companies reported importing over 1 850 000 kg and using approximately 3 270 000 kg in that year. Between 1 000 and 10 000 kg of antimony oxide were released into the environment in 2006, with the majority released to landfill sites. In Canada, antimony oxide is used primarily as a plastic catalyst in manufacturing polyethylene terephthalate and as a synergist with halogenated compounds to provide flame retardancy properties. Flame retardants are used in a variety of household items, including furniture upholstery, carpets, mattress covers and other textiles.

Based on available information on concentrations of antimony in environmental media (soil, drinking water, ambient air) and food, as well as results for antimony oxide from a survey under section 71 of CEPA 1999, the general population is expected to be exposed primarily to antimony oxide from household items containing flame retardants. However, the total exposure level to antimony oxide resulting from household products and environmental media identified in this screening assessment is expected to be low.

As antimony oxide was classified on the basis of carcinogenicity by international regulatory agencies, carcinogenicity was a key focus for this screening assessment. Lung tumours were observed in female but not male rats exposed to the highest concentrations of antimony oxide tested in one-year inhalation bioassays. No evidence was available to suggest carcinogenic potential for antimony oxide via the oral route. Collective evidence from genotoxicity studies suggests that antimony oxide is not likely to be mutagenic but may exert some clastogenic effects in vitro. The mode of action for induction of tumours proposed by other regulatory agencies links to local inflammatory response and pulmonary overload. Although the mode of induction of tumours is not fully elucidated, the tumours observed are not considered to have resulted from direct interaction with genetic material. Therefore, a threshold approach is used to characterize risk to human health.

There was some evidence for adverse effects on fertility in limited animal developmental and reproductive toxicity studies, as well as in epidemiological studies. The critical effect concentration for non-cancer effects was based on an increase in lung weight, pulmonary changes and no significant increase incidence of lung tumours in female rats exposed to antimony oxide for a year. For the oral route, the critical effect level was based on histopathological changes of the liver and an increase of serum glutamic oxalacetic transaminase in male rats administered antimony oxide for 24 weeks. The critical effect levels were also below the levels where reproductive and developmental toxicity may occur. The margins between upper-bounding estimates of exposure to antimony oxide from environmental media, based on antimony, and use of household items, and levels associated with effects in experimental animals are considered to be adequately protective to account for uncertainties in the health effects and exposure database.

On the basis of the adequacy of the margins between conservative estimates of exposure to antimony oxide and critical effect levels in experimental animals, it is proposed to conclude that antimony oxide 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.

Antimony oxide is released into the Canadian environment mainly as a result of its use as a flame retardant and as atmospheric emissions from fossil-fuel combustion and non-ferrous metal production. Following these emissions, deposition to surrounding terrestrial and aquatic ecosystems occurs. Because antimony oxide has a certain solubility, it will dissolve in contact with moisture once in these ecosystems and will yield a variety of dissolved antimony species depending on the environmental conditions. Antimony has been demonstrated to have a moderate potential to cause harm to aquatic, soil and sediment organisms.

Site-specific industrial scenarios based on monitoring data were developed for the most important sources of releases of antimony oxide to the environment. Modelled exposure aquatic concentrations were also estimated mainly for the plastics industry from the use of antimony oxide as a flame retardant. Based on a risk quotient analysis, harm to aquatic and terrestrial organisms resulting from exposure to antimony oxide is unlikely. Hence, it is proposed to conclude that the substance is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. Antimony oxide does meet the criteria for persistence but does not meet the criteria for bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations.

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

Proposed conclusion

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

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