Vol. 143, No. 31 — August 1, 2009

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

Publication of Final Decision on the Screening
Assessment of Substances — Batch 4

CAS No. 64325-78-6
CAS No. 1154-59-2
CAS No. 1176-74-5
CAS No. 70776-86-2
CAS No. 68443-10-7
CAS No. 64-67-5
CAS No. 68921-45-9
CAS No. 110-54-3
CAS No. 115-39-9
CAS No. 115-40-2
CAS No. 125-31-5
CAS No. 17321-77-6
CAS No. 62625-32-5
CAS No. 68308-48-5
CAS No. 79357-73-6

Publication of Results of Investigations and
Recommendations for Substances

CAS No. 77-78-1
CAS No. 106-97-8
CAS No. 75-28-5

Publication of final decision on the screening assessment of five substances — Adenosine, N-benzoyl-5′-O-[bis(4-methoxyphenyl) phenylmethyl]-2′-deoxy- (DMTBA), CAS No. 64325-78-6; Benzamide, 3,5-dichloro-N-(3,4-dichlorophenyl)-2-hydroxy-(3,3′,4′,5-tetrachlorosalicylanilide), CAS No. 1154-59-2; Benzoic acid, 2-[(3,5-dibromo-4-hydroxyphenyl)(3,5-dibromo-4-oxo-2,5-cyclohexadien-1-ylidene)methyl]-, ethyl ester (Bromophthalein Magenta E), CAS No. 1176-74-5; 2-Butanone, 4-[[[1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenyl]methyl](3-oxo-3-phenylpropyl)amino]-, [1R-(1α,4αβ,10aα)]- (BODPA), CAS No. 70776-86-2; and Amines, C_18-22-tert-alkyl, ethoxylated (ATAE), CAS No. 68443-10-7 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas DMTBA, 3,3′,4′,5-tetrachlorosalicylanilide, Bromophthalein Magenta E, BODPA and ATAE are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the final Screening Assessment Report conducted on DMTBA, 3,3′,4′,5-tetrachlorosalicylanilide, Bromophthalein Magenta E, BODPA and ATAE 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 DMTBA, 3,3′,4′,5-tetrachlorosalicylanilide, Bromophthalein Magenta E, BODPA and ATAE above 100 kg per calendar year;

Whereas DMTBA, 3,3′,4′,5-tetrachlorosalicylanilide, Bromophthalein Magenta E, BODPA and ATAE 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 the above substances,

Notice therefore is hereby given that the Ministers of the Environment and of Health intend to take no further action on DMTBA, 3,3′,4′,5-tetrachlorosalicylanilide, Bromophthalein Magenta E, BODPA and ATAE at this time under section 77 of the Act.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment of the five substances listed below conducted under section 74 of the Canadian Environmental Protection Act, 1999

CAS RN*	DSL Name
64325-78-6	Adenosine, N-benzoyl-5′-O-[bis(4-methoxyphenyl)phenylmethyl]-2′-deoxy-
1154-59-2	Benzamide, 3,5-dichloro-N-(3,4-dichlorophenyl)-2-hydroxy-
1176-74-5	Benzoic acid, 2-[(3,5-dibromo-4-hydroxyphenyl)(3,5-dibromo-4-oxo-2,5-cyclohexadien-1-ylidene)methyl]-, ethyl ester
70776-86-2	2-Butanone, 4-[[[1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenyl]methyl](3-oxo-3-phenylpropyl)amino]-, [1R-(1α,4αβ,10aα)]-
68443-10-7	Amines, C18-22-tert-alkyl, ethoxylated

*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 Ministerial Challenge, because they met the ecological categorization criteria for persistence (P), bioaccumulation (B) and inherent toxicity to non-human organisms (iT), under paragraph 73(1)(b) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), and were believed to be in commerce in Canada. The substances were not considered to be a high priority for assessment of potential risks to human health.

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 2006 and November 2007 revealed no reports of industrial activity (import or manufacture) with respect to these substances in Canada, equal to or above the reporting threshold of 100 kg, for the specified reporting years of 2005 and 2006. 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. Other sources of entry into the environment have not been identified at this time.

Information received as a result of the above notices issued under paragraph 71(1)(b) of CEPA 1999 and the accompanying questionnaire of November 2007 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 inherently toxic to non-human organisms. They also meet the criteria for both persistence and bioaccumulation as set out in the Persistence and Bioaccumulation Regulations.

Conclusion

Based on available information, and until new information is received indicating that any of these substances is entering or may enter the environment from commercial activity in Canada or other sources, the above five substances are currently not entering, nor are they likely to enter, the environment. Therefore, these substances do not meet the criteria set out in section 64 of CEPA 1999.

As substances listed on the DSL, import and manufacture of these five substances in Canada are not subject to notification under subsection 81(1). Given their hazardous PBiT properties, there is concern that new activities for the above five substances which have not been identified or assessed under the Canadian Environmental Protection Act, 1999 could lead to the substances meeting the criteria set out in section 64 of the Act. Therefore, it is recommended that the above five substances be subject to the Significant New Activity provisions specified under subsection 81(3) of the Act, to ensure that any new manufacture, import or use of these substances in quantities greater than 100 kg/year is notified and that the substances will undergo ecological and human health risk assessments as specified in section 83 of the Act, prior to the substance being introduced into Canada.

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

Publication of final decision on the screening assessment of a substance — Sulfuric acid, diethyl ester (diethyl sulfate), CAS No. 64-67-5 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

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

Whereas a summary of the final Screening Assessment Report conducted on diethyl sulfate pursuant to section 74 of the Act is annexed hereby; and

Whereas diethyl sulfate 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 diethyl sulfate be added to Schedule 1 to the Act.

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

Public comment period on the proposed risk management approach document

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the risk management approach document. More information regarding the proposed risk management approach may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment Report of Sulfuric acid, diethyl ester

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Sulfuric acid, diethyl ester (diethyl sulfate), Chemical Abstracts Service Registry No. 64-67-5. This substance was identified in the categorization of the Domestic SubstancesList as a high priority for action under the Challenge. Diethyl sulfate was identified as presenting an intermediate potential for exposure to individuals in Canada and had been classified by other agencies on the basis of carcinogenicity and genotoxicity. Since the substance did not meet the ecological categorization criteria for bioaccumulation, persistence or inherent toxicity to aquatic organisms, the focus of this assessment relates to human health aspects.

According to data submitted in response to section 71 of CEPA 1999, no companies in Canada reported manufacturing diethyl sulfate in a quantity greater than or equal to the threshold of 100 kg for the 2006 calendar year. However, it was reported that approximately 1 000 kg were imported into Canada for the same year. The responses to the section 71 request indicated that diethyl sulfate is mainly used in Canada as a chemical intermediate in the tissue paper industry. Based on information presented in the available scientific and technical literature, diethyl sulfate may be used as a chemical intermediate in the preparation of a variety of other substances and products, including dyes, fragrances, and quaternary ammonium salts used as surfactants or flocculants in water treatment. It may also be used as an ethylating agent to convert compounds such as phenols and thiols to their corresponding ethyl derivatives in the manufacture of commercial products such as sanitizers and organoclays.

Diethyl sulfate is not a naturally occurring compound. Emissions of diethyl sulfate into the environment are only expected to come from anthropogenic sources. The principal route of exposure for the general population would likely be through inhalation, based on its moderate vapour pressure. However, as diethyl sulfate is used principally in closed systems, releases are likely to be very low and would be rapidly hydrolyzed. Therefore, population exposure in the general environment is expected to be negligible. Consumer exposure to residual diethyl sulfate in products is also expected to be insignificant.

Based on the weight-of-evidence assessments of international and other national agencies and taking into consideration more recent data, the critical effect for the characterization of risks to human health for diethyl sulfate is carcinogenicity. Increased incidences of tumours (principally at the site of administration) were observed in rats and mice exposed via ingestion, dermal application or subcutaneous injection. Tumours were also observed in pups of rats exposed to diethyl sulfate during pregnancy. Diethyl sulfate was also consistently genotoxic in a range of in vivo and in vitro assays and is a strong DNA alkylating agent. While the mode of induction of tumours by diethyl sulfate has not been fully elucidated, it cannot be precluded that the tumours observed in experimental animals have resulted from direct interaction with genetic material.

On the basis of the carcinogenic potential of diethyl sulfate, for which there may be a probability of harm at any exposure level, it is concluded that diethyl sulfate is a substance that is entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

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

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

Conclusion

Based on the information available, it is concluded that diethyl sulfate meets one or more of the criteria set out in section 64 of CEPA 1999.

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

Publication of results of investigations and recommendations for the substance — Sulfuric acid, dimethyl ester (dimethyl sulfate), CAS No. 77-78-1 — specified on the Domestic Substances List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Whereas a summary of the final Screening Assessment Report conducted on dimethyl sulfate pursuant to paragraph 68(b) of the Canadian Environmental Protection Act, 1999 is annexed hereby; and

Whereas dimethyl sulfate 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 intend to recommend to Her Excellency the Governor in Council that dimethyl sulfate be added to Schedule 1 to the Act.

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

Public comment period on the proposed risk management approach document

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the risk management approach document. More information regarding the proposed risk management approach may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment Report of Sulfuric acid, dimethyl ester

The Ministers of the Environment and of Health have conducted a screening assessment of Sulfuric acid, dimethyl ester (dimethyl sulfate), Chemical Abstracts Service Registry No. 77-78-1. This substance was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. Dimethyl sulfate was identified as presenting an intermediate potential for exposure to individuals in Canada and had been classified by other agencies on the basis of carcinogenicity and genotoxicity. Since dimethyl sulfate did not meet the criteria for bioaccumulation or inherent toxicity to aquatic organisms, the focus of this assessment relates to human health aspects.

According to data submitted in response to a notice issued under section 71 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), no companies in Canada reported manufacturing dimethyl sulfate in a quantity greater than or equal to the threshold of 100 kg for the 2006 calendar year. However, it was reported that approximately 1 000 kg were imported into Canada in that year. The response to the section 71 notice request indicated that dimethyl sulfate is mainly used in Canada as an intermediate by the pharmaceutical industry. Based on information presented in the available scientific and technical literature, dimethyl sulfate may also be applied as a methylating agent to convert compounds such as phenols and amines to their methyl derivatives in the production of products such as dyes, fragrances, surfactants, and water/sewage treatment flocculants. Other products, such as photographic chemicals, can also be produced through the alkylation of dimethyl sulfate using nitrogen, oxygen and/or sulphur.

Emissions of dimethyl sulfate into the ambient environment are expected to come primarily from anthropogenic sources. Dimethyl sulfate may also be formed in atmospheric emissions from facilities burning fossil fuels containing sulfur. The principal route of exposure for the general population will likely be through inhalation of ambient air; exposure from other media is likely negligible. Consumer exposure to residual dimethyl sulfate in products is also expected to be insignificant.

Based principally on weight-of-evidence assessments of international and other national agencies, the critical effect for the characterization of risks to human health is carcinogenicity. Increased incidences of tumours were observed in multiple species of experimental animals exposed via inhalation or subcutaneous injection. Tumours were also observed in pups of rats exposed to dimethyl sulfate during pregnancy. Dimethyl sulfate was also consistently genotoxic in a range of in vivo and in vitro assays and is a strong DNA alkylating agent. While the mode of induction of tumours by dimethyl sulfate has not been fully elucidated, it cannot be precluded that the tumours observed in experimental animals have resulted from direct interaction with genetic material.

On the basis of the carcinogenic potential of dimethyl sulfate, for which there may be a probability of harm at any exposure level, it is concluded that dimethyl sulfate is a substance that is entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

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

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

Conclusion

Based on the information available, it is concluded that dimethyl sulfate meets one or more of the criteria set out in section 64 of CEPA 1999.

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

Publication of final decision on the screening assessment of a substance — Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene (BNST), CAS No. 68921-45-9 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

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

Whereas a summary of the final Screening Assessment Report conducted on BNST pursuant to section 74 of the Act is annexed hereby;

Whereas BNST meets one or more of the criteria set out in section 64 of the Act; and

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

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

Notice therefore is further given that the Ministers of the Environment and of Health propose the implementation of virtual elimination of BNST under subsection 65(3) of the Act.

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

Public comment period on the proposed risk management approach document

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the risk management approach document. More information regarding the proposed risk management approach may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment Report of Benzenamine, N-phenyl-,
reaction products with styrene and 2,4,4-trimethylpentene

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 Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene (BNST) Chemical Abstracts Service Registry No. 68921-45-9. This substance was identified as a high priority for screening assessment and was 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 BNST was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

The substance BNST is an organic substance that is not naturally produced in the environment. Between 100 001 and 1 000 000 kg of BNST were imported into Canada in 2006, and between 1 000 000 and 10 000 000 kg were manufactured in 2006. The quantity of BNST that is manufactured and imported into Canada, along with the dispersive uses of this substance, indicate that significant quantities could be released into the Canadian environment.

The majority of BNST that is manufactured in Canada is exported. Of the amount imported and used in Canada, it is estimated that 98.3% is chemically transformed, combusted, incinerated or re-used during use and following disposal. Small proportions are estimated to be released during use to sewer (0.9%) and soil (0.6%). A total of 0.2% is expected to end up in waste disposal sites. Approximately 0.2% is expected to be released to sewers during cleaning of containers used to transport additive packages containing BNST.

The substance BNST has very low solubility in water, has low volatility and has a tendency to partition to particles and lipids (fat) of organisms because of its hydrophobic nature. For these reasons, BNST will likely be found mostly in soil and sediments. It is not expected to be present in large amounts in other media. It is also not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, BNST is not anticipated to degrade quickly in the environment. It is expected to be persistent in water, soil and sediments. The substance BNST also has the potential to accumulate in organisms and may biomagnify in trophic food chains. The substance has been determined to meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, acute aquatic toxicity estimates indicate that the substance may be moderately to highly hazardous to aquatic organisms.

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

Based on the information presented in this screening assessment, it is concluded that BNST is entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity.

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

Conclusion

Based on the information available, it is concluded that BNST meets one or more of the criteria set out in section 64 of CEPA 1999. The substance BNST is persistent and bioaccumulative in accordance with the regulations, its presence in the environment results primarily from human activity, and it is not a naturally occurring radionuclide or a naturally occurring inorganic substance.

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

Publication of final decision on the screening assessment of a substance — Hexane (n-hexane), CAS No. 110-54-3 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

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

Whereas a summary of the final Screening Assessment Report conducted on n-hexane pursuant to section 74 of the Act is annexed hereby; and

Whereas n-hexane 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 intend to take no further action on n-hexane at this time under section 77 of the Act.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment Report of n-hexane

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 n-hexane, Chemical Abstracts Service Registry No. 110-54-3. This substance was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge, as it was considered to pose greatest potential for exposure to individuals in Canada and had been classified by the European Commission on the basis of reproductive toxicity. The substance did not meet the ecological categorization criteria for persistence or bioaccumulation potential. Therefore, the focus of this assessment of n-hexane relates to human health risks.

The substance n-hexane is a naturally occurring component of crude oil and natural gas and is present in refined petroleum products such as motor fuels. According to data submitted in CEPA 1999 section 71 responses, over 5 billion kilograms of n-hexane were manufactured and 10–100 million kilograms of n-hexane were imported into Canada in 2006. Although the section 71 survey did not apply to activities of n-hexane in fuel, both reported quantities included activities related to fuel.

The physical and chemical properties of n-hexane make this substance ideal for many uses and applications. It is used as a solvent, a formulation component, a chemical intermediate, a processing aid, and a dispersant in various chemical processes. Another major use of n-hexane besides its use in petroleum is in food processing as a solvent for extraction of vegetable oils. A wide variety of products known to contain n-hexane in Canada include adhesives, sealants, binders, fillers, lubricants, paints and coatings, rubber and rubber cements, brake cleaners, and degreasers.

The substance n-hexane has been measured in ambient and indoor air in Canada, and the major route of exposure to n-hexane by the general population of Canada, is expected to be inhalation. Exposure from other media (drinking water, soil) and food was estimated not to contribute significantly to total exposures.

Products containing n-hexane are used primarily for professional purposes and exposure to n-hexane by the general population from these sources is expected to be minimal and infrequent.

The critical effect level for repeated-dose toxicity via inhalation was based not only on nervous system effects in a 24-week rat inhalation study but also on increased number of resorptions in a mouse developmental toxicity study. The margin of exposure between the critical effect level for inhalation and the upper-bounding exposure estimate for n-hexane is considered to be adequately protective.

The critical effect level for repeated-dose toxicity via the oral route was based on adverse effects in heart muscle and related parameters in a 30-day rat study. Comparison of the critical effect level for repeated dose effects via the oral route and the upper-bounding estimate of daily intake of n-hexane by the general population in Canada, yields a margin of exposure that is considered to be adequately protective.

Based on the available information on its potential to cause harm to human health and the resulting margins of exposure for repeated-dose effects, it is concluded that n-hexane is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

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

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

Conclusion

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

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

Publication of final decision on the screening assessment of a substance — Phenol, 4,4′ -(3H-2,1-benzoxathiol-3-ylidene)bis[2,6-dibromo-, S,S-dioxide (Bromophenol Blue), CAS No. 115-39-9 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

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

Whereas a summary of the final Screening Assessment Report conducted on Bromophenol Blue pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Bromophenol Blue 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 intend to take no further action on Bromophenol Blue at this time under section 77 of the Act.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment on Phenol,
4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2,6-dibromo-, S,S-dioxide

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2,6-dibromo-, S,S-dioxide (Bromophenol Blue), Chemical Abstracts Service Registry No. 115-39-9. 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 Bromophenol Blue was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Bromophenol Blue is an organic substance that can be used as an analytical reagent in laboratories. This substance was not in commerce in significant quantities in Canada in 2006, indicating that its release to the Canadian environment is likely very low. Based on possible uses of this substance, it could end up in water bodies or landfills. Since Bromophenol Blue is highly soluble in water, is not volatile and does not have a tendency to bind to particles, it could be found in surface water, and possibly in groundwater following leaching through soil.

Based on its physical and chemical properties, Bromophenol Blue does not degrade quickly in the environment and is expected to be persistent in water and soil. Bromophenol Blue does not have the potential to accumulate in organisms. This substance has been determined to meet the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, it is not highly hazardous to aquatic organisms (LC₅₀/EC₅₀ > 1 mg/L).

For this screening assessment, a highly conservative exposure scenario was selected in which a facility (user of the substance) discharges Bromophenol Blue into the aquatic environment. The predicted environmental concentration in water was many orders of magnitude below predicted no-effect concentrations calculated for fish, daphnids and algae. Thus, this substance is not believed to cause ecological harm in the aquatic environment.

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

Conclusion

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

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

Publication of final decision on the screening assessment of a substance — Phenol, 4,4′-(3H-2,1-benzoxathiol-3-ylidene) bis[2-bromo-6-methyl-, S,S-dioxide (Bromcresol Purple), CAS No. 115-40-2 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

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

Whereas a summary of the final Screening Assessment Report conducted on Bromcresol Purple pursuant to section 74 of the Act is annexed hereby; and

Whereas Bromcresol Purple 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 intend to take no further action on Bromcresol Purple at this time under section 77 of the Act.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment on Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)
bis[2-bromo-6-methyl-, S,S-dioxide

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2-bromo-6-methyl-, S,S-dioxide (Bromcresol Purple), Chemical Abstracts Service Registry No. 115-40-2. This substance was identified as a high priority for screening assessment and included in the Challenge because it had originally 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 Bromcresol Purple was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Bromcresol Purple is an organic substance used mainly as an analytical reagent in laboratories. This substance was not in commerce in significant quantities in Canada in 2006, indicating that its release to the Canadian environment is likely very low. Based on possible uses of this substance, if released, it would most likely be to water bodies or landfills. Since Bromcresol Purple is expected to be soluble in water, is not volatile and does not have a tendency to bind to particles (based on data for an analogue chemical), it could be found in surface water and possibly in groundwater following leaching through soil.

Based on its physical and chemical properties, Bromcresol Purple does not degrade quickly in the environment and is expected to be persistent in water and soil. Based on currently available information, Bromcresol Purple does not have the potential to accumulate in organisms. This substance has been determined to meet the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, it is not highly hazardous to aquatic organisms (LC₅₀/EC₅₀ > 1 mg/L).

For this screening assessment, a highly conservative exposure scenario was selected in which a facility (user of the substance) discharges Bromcresol Purple into the aquatic environment. The predicted environmental concentration (PEC) in water was many orders of magnitude below predicted no-effect concentrations (PNECs) calculated for fish, daphnids and algae. Thus, this substance is not believed to cause ecological harm in the aquatic environment.

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

Conclusion

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

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

Publication of final decision on the screening assessment of a substance — Phenol, 4,4′-(3H-2,1-benzoxathiol-3-ylidene)bis[2,5-dimethyl-, S,S-dioxide (Xylenol Blue), CAS No. 125-31-5 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

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

Whereas a summary of the final Screening Assessment Report conducted on Xylenol Blue pursuant to section 74 of the Act is annexed hereby; and

Whereas Xylenol Blue 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 intend to take no further action on Xylenol Blue at this time under section 77 of the Act.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment on
Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2,5-dimethyl-, S,S-dioxide

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Phenol, 4,4'- (3H-2,1-benzoxathiol-3-ylidene)bis[2,5-dimethyl-, S,S-dioxide (Xylenol Blue), Chemical Abstracts Service Registry No. 125-31-5. This substance was identified as a high priority for screening assessment and included in the Challenge because it had originally 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 Xylenol Blue was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Xylenol Blue is an organic substance used mainly as an analytical reagent in laboratories. This substance was likely not in commerce in Canada in 2006, indicating that its release to the Canadian environment is likely very low. Based on possible uses of this substance, it could end up in water bodies or landfills. Since Xylenol Blue is expected to be highly soluble in water, is not volatile and does not have a tendency to bind to particles (based on data for an analogue chemical); if released to water or soil, Xylenol Blue could be found in surface water and possibly in groundwater following leaching through soil.

Based on its physical and chemical properties, Xylenol Blue does not degrade quickly in the environment and is expected to be persistent in water and soil. Based on currently available information, Xylenol Blue does not have the potential to accumulate in organisms. This substance has been determined to meet the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, currently available information indicates that it is not highly hazardous to aquatic organisms (LC₅₀/EC₅₀ > 1 mg/L).

For this screening assessment, a highly conservative exposure scenario was selected in which a facility (user of the substance) discharges Xylenol Blue into the aquatic environment. The predicted environmental concentration (PEC) in water was many orders of magnitude below predicted no-effect concentrations (PNECs) calculated for fish, daphnids and algae. Thus, this substance is not believed to cause ecological harm in the aquatic environment.

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

Conclusion

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

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

Publication of final decision on the screening assessment of a substance — 5H-Dibenz[b,f]azepine-5-propanamine, 3-chloro-10,11-dihydro-N,N-dimethyl-, monohydrochloride (clomipramine hydrochloride), CAS No. 17321-77-6 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

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

Whereas a summary of the final Screening Assessment Report conducted on clomipramine hydrochloride pursuant to section 74 of the Act is annexed hereby; and

Whereas clomipramine hydrochloride 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 intend to take no further action on clomipramine hydrochloride at this time under section 77 of the Act.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment on 5H-Dibenz[b,f]azepine-5-propanamine,
3-chloro-10,11-dihydro-N,N-dimethyl-, monohydrochloride

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 5H-Dibenz[b,f]azepine-5-propanamine, 3-chloro-10,11-dihydro-N,N-dimethyl-, monohydrochloride (Clomipramine hydrochloride), Chemical Abstracts Service Registry Number (CAS RN) 17321-77-6. Clomipramine hydrochloride was identified as a high priority for screening assessment and included in the Challenge because it was initially found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada. Few data are available for clomipramine hydrochloride and many of the measured and predicted values used in this screening assessment are for the related compound, clomipramine (CAS RN 303-49-1).

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

Clomipramine hydrochloride is an organic substance that is used as a pharmaceutical product for humans and animals. The substance is not naturally produced in the environment. The available information indicates that, in 2006, clomipramine hydrochloride was not manufactured in Canada in quantities equal to or greater than the reporting threshold of 100 kg; however, one company reported importing the substance in the range of 100 to 1 000 kg per year and a second reported importing it in an amount below the threshold quantity of 100 kg. In addition, several Canadian companies identified themselves as having a stakeholder interest in the substance. Overall, it would appear that clomipramine hydrochloride is not present in large quantities in Canadian commerce and, therefore, potential releases of the substance to the Canadian environment are considered to be low. In addition, based on reported use patterns and other information, most of the substance (97%) is expected to be chemically transformed (metabolized) during use, with only a small proportion of the original compound released into wastewaters (2.5%) and soil (0.5%).

Experimental and predicted values of greater than nine for the acid dissociation constant (pK_a) suggest that ionization of clomipramine hydrochloride is almost complete at typical pH values in the environment, with the ionized form acting as a weak base. Therefore, clomipramine hydrochloride entering the environment is expected to reside predominantly in water, although some partitioning to sediment and/or soil may also occur depending on the compartment of release.

Based on ultimate degradation results from several quantitative structure-activity relationship (QSAR) models, clomipramine hydrochloride meets persistence criteria (half-life ≥ 182 days in water and soil and > 365 days in sediment) as set out in the Persistence and Bioaccumulation Regulations.

Clomipramine hydrochloride was categorized as bioaccumulative based on model predictions for the neutral compound. However, given the evidence for ionization and metabolism, as well as predicted bioaccumulation and bioconcentration factors (BAF/ BCF) ranging from 7 to 155 for the ionized form expected to predominate at environmental pH (6 to 9), it is considered unlikely to accumulate to significant levels in organisms and, therefore, does not meet bioaccumulation criteria in the Persistence and Bioaccumulation Regulations.

Clomipramine hydrochloride is predicted to have moderate to high aquatic toxicity (acute LC₅₀ values for the ionized form range from < 1–10 mg/L) and therefore is considered to be potentially hazardous to aquatic organisms. Experimental data indicate that clomipramine hydrochloride has low mammalian toxicity. A risk quotient analysis, integrating a conservative predicted environmental concentration (PEC) with a predicted no-effect concentration (PNEC) resulted in a risk quotient (PEC/PNEC) value of 0.03, indicating that concentrations of clomipramine hydrochloride in water are unlikely to cause adverse effects to populations of pelagic organisms in Canada.

While clomipramine hydrochloride meets the criteria for persistence and is predicted to be potentially hazardous to aquatic species, given the low quantities in commerce and its dispersive uses, it is considered to have low exposure potential and to present a negligible risk to the Canadian environment.

Therefore, it is concluded that clomipramine hydrochloride is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

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

Conclusion

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

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

Publication of final decision on the screening assessment of a substance — Phenol, 4,4′-(3H-1,2-benzoxathiol-3-ylidene)bis[2,6-dibromo-3-methyl-, S,S-dioxide, monosodium salt (PBTBO), CAS No. 62625-32-5 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

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

Whereas a summary of the final Screening Assessment Report conducted on PBTBO pursuant to section 74 of the Act is annexed hereby; and

Whereas PBTBO 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 intend to take no further action on PBTBO at this time under section 77 of the Act.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment on Phenol, 4,4'-(3H-1,2-benzoxathiol-3-ylidene)bis[2,6-dibromo-3-methyl-, S,S-dioxide, monosodium salt

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Phenol, 4,4'-(3H-1,2-benzoxathiol-3-ylidene)bis[2,6-dibromo-3-methyl-, S,S-dioxide, monosodium salt (PBTBO), Chemical Abstracts Service Registry No. 62625-32-5. This substance was identified as a high priority for screening assessment and included in the Challenge because it had originally 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 PBTBO was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

The substance PBTBO is an organic substance that can be used as an analytical reagent in laboratories. A total quantity of 2 363 kg was imported into Canada in 2006. Based on possible uses of this substance, it could end up in water bodies. Since PBTBO is expected to be highly soluble in water, is not volatile and does not have a tendency to bind to particles (based on data for an analogue chemical), it could be found in surface water but not in sediments.

Based on its physical and chemical properties, PBTBO does not degrade quickly in the environment. It is therefore expected to be persistent in water and soil. The substance PBTBO does not have the potential to accumulate in organisms. This substance has been determined to meet the persistence criteria but not the bioaccumulation criterion as set out in the Persistence and Bioaccumulation Regulations. In addition, it is not highly hazardous to aquatic organisms (LC₅₀/EC₅₀ > 1 mg/L).

For this screening assessment, a reasonable worst-case exposure scenario was selected in which a facility (user of the substance) discharges PBTBO into the aquatic environment. The predicted environmental concentration in water was a few orders of magnitude below predicted no-effect concentrations calculated for fish, daphnids and algae. Thus, this substance is not anticipated to cause ecological harm in the aquatic environment.

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

Conclusion

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

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

Publication of final decision on the screening assessment of a substance — Amines, tallow alkyl, ethoxylated, phosphates (ATAEP), CAS No. 68308-48-5 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

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

Whereas a summary of the final Screening Assessment Report conducted on ATAEP pursuant to section 74 of the Act is annexed hereby; and

Whereas ATAEP 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 intend to take no further action on ATAEP at this time under section 77 of the Act.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment on Amines, tallow alkyl, ethoxylated, phosphates

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 Amines, tallow alkyl, ethoxylated, phosphates (ATAEP), Chemical Abstracts Service Registry No. 68308-48-5. This substance was identified as a high priority for screening assessment and included in the Challenge because it was originally 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 ATAEP was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

The substance ATAEP is an organic substance that is in commerce in Canada. A new use of this substance (the use and activity are regarded as a confidential business activity) has been identified since 2005 when it was reported to be used mainly in down-the-drain consumer products such as soaps and lotions. The amount manufactured in 2006 in Canada was reported to range from 100 to 1 000 kg. This information on manufacture and use indicates that ATAEP could potentially be released into the Canadian environment.

Based on certain assumptions and reported use patterns, most of the substance that is manufactured in Canada ends up in soil. Small proportions are estimated to be transferred to waste disposal sites (2%) or released to water (1.4%), with the majority being emitted to soil (96.6%).

The substance ATAEP is an alkyl phosphate ester, that is expected to have a net charge of zero at ambient pHs. It is therefore considered to behave as a neutral molecule, having a low solubility in water, a low volatility and a high K_oc. It will thus have a tendency to partition to particles or to lipids (fat) of organisms. For these reasons, ATAEP will likely be found mostly in soil or sediments. It is not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, ATAEP does degrade quickly in the environment. It is therefore not expected to be persistent in air, water, soil or sediments. ATAEP has a low potential to accumulate in organisms. The substance has been determined to not meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. Modelled acute aquatic toxicity values suggest however that the substance has a relatively high potential for toxicity to aquatic organisms.

In this screening assessment, conservative exposure scenarios were developed to estimate releases into the aquatic environment from industrial operations as well as consumer uses, and resulting aquatic concentrations. The obtained predicted environmental concentrations in water are lower than the predicted no-effect concentration for fish, daphnids and algae. This indicates that the substance is not anticipated to cause ecological harm in the aquatic environment. In addition, because of the relatively small quantity in commerce and the nature of its use, little exposure of soil-dwelling biota is anticipated. Therefore, ATAEP is unlikely to pose significant risk to soil organisms.

Based on the information presented in this screening assessment, it is concluded that ATAEP is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

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

Conclusion

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

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

Publication of final decision on the screening assessment of a substance — Amines, C_18-22 -tert-alkyl, (chloromethyl)phosphonates (2:1) [ATACP], CAS No. 79357-73-6 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

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

Whereas a summary of the final Screening Assessment Report conducted on ATACP pursuant to section 74 of the Act is annexed hereby; and

Whereas ATACP 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 intend to take no further action on ATACP at this time under section 77 of the Act.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Screening Assessment on Amines, C_18-22-tert-alkyl, (chloromethyl)phosphonates (2:1)

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Amines, C_18-22-tert-alkyl, (chloromethyl)phosphonates (2:1) (ATACP), Chemical Abstracts Service Registry No. 79357-73-6. This substance was identified as a high priority for screening assessment and included in the Challenge because it had originally 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 ATACP was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

The substance ATACP is a complex organic substance, not naturally produced in the environment. While no companies have reported the manufacture (whether alone, in a product or in a mixture) of ATACP in Canada, between 100 and 1 000 kg of ATACP were imported into Canada in 2006. All uses of ATACP in Canada have been claimed as confidential business information. However, these uses have been taken into consideration in conducting this assessment. In other countries, ATACP is reported to be used as a lubricant and an additive. The potentially dispersive uses of this substance, indicate that there may be releases into the Canadian environment.

Based on reported use patterns and certain assumptions, the majority of the substance is expected to end up in waste disposal facilities (96.8%). The rest is expected to be chemically transformed during incineration (3.0%), or released to air (0.1%), or released to sewers (0.1%).

The substance ATACP is a salt which dissociates in water and, for this reason, an assessment was made of its two components, a positively charged alkyl amine and a negatively charged phosponic acid counterion. Based on modelled physical and chemical properties, the alkyl amine is expected to degrade relatively quickly in air, but is likely persistent in water, soil and sediment. On the other hand, the phosphonic acid counterion is persistent in air but is not likely to persist in water, soil and sediment. Both counterions are also not expected to accumulate to a significant extent in organisms or biomagnify in food chains. While the components of ATACP do not meet the bioaccumulation criteria, they do meet some of the persistence criteria (in air for phosphonic acid and in water soil and sediment for the alkyl amine) as set out in the Persistence and Bioaccumulation Regulations. Modelled acute aquatic toxicity values suggest that the alkyl amine has a moderate to high potential for toxicity to aquatic organisms, whereas the phosphonic acid counterion exhibits little or no potential for aquatic toxicity.

As minimal releases into the aquatic environment from industrial operations or other sources are expected, this substance is not believed to cause ecological harm in the aquatic environment.

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

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

Conclusion

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

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

Publication of results of investigations and recommendations for the substances — Butane, CAS No. 106-97-8, containing 1,3-butadiene and Isobutane, CAS No. 75-28-5, containing 1,3-butadiene — specified on the Domestic Substances List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Whereas butane and isobutane are substances identified as high priorities for action under the Ministerial Challenge, published in the Canada Gazette, Part I, on December 9, 2006;

Whereas butane and isobutane have been classified as carcinogens by the European Commission when they contain 1,3-butadiene (CAS No. 106-99-0) at a concentration greater than or equal to 0.1%;

Whereas the summary of an investigation conducted on butane containing 1,3-butadiene and isobutane containing 1,3-butadiene is annexed hereby; and

Whereas 1,3-butadiene is a substance on Schedule 1 to the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health recommend that the exposure to 1,3-butadiene from the uses of butane and isobutane identified in this investigation be considered in relation to ongoing risk management activities undertaken for 1,3-butadiene under the Act.

Notice is furthermore given that the Ministers of the Environment and of Health will conduct a screening assessment of butane and isobutane — substances on the Domestic Substances List identified under subsection 73(1) of the Act — pursuant to section 74.

JIM PRENTICE
Minister of the Environment

LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of Investigation of Butane Containing 1,3-Butadiene
and Isobutane Containing 1,3-Butadiene

Butane (Chemical Abstracts Service Registry Number [CAS RN] 106-97-8) and isobutane (CAS RN 75-28-5) were identified in the categorization of the Domestic Substances List as high priorities for action under the Ministerial Challenge as they were considered to pose “greatest potential for exposure” to individuals in Canada and had been classified by the European Commission on the basis of carcinogenicity when they contain 1,3-butadiene (CAS RN 106-99-0) at a concentration greater than or equal to 0.1%. The substance 1,3-butadiene was assessed in Canada under the Priority Substances List 2 (PSL 2) of the Canadian Environmental Protection Act, 1999 and it was determined that 1,3-butadiene was likely to be carcinogenic in humans and may also be associated with genotoxicity and reproductive toxicity. It was not found to present a risk to the environment, but was found to contribute to the photochemical formation of ground-level ozone. Therefore, the focus of this investigation was to evaluate the exposure to and potential risk to human health from 1,3-butadiene in butane and isobutane in Canada. A screening assessment of the chemical substances butane and isobutane, in the absence of 1,3-butadiene, will be conducted with the group of substances that are of medium priority for assessment as a result of categorization. In addition, end-use fuels (e.g. motor vehicle gasoline, liquefied petroleum gas) formulated with butane and isobutane will be addressed under the Petroleum Sector Stream Approach of the Chemicals Management Plan.

Butane and isobutane containing residual amounts of 1,3-butadiene are both manufactured in and imported into Canada in high volumes. Butane and isobutane contain 1,3-butadiene as a refinery by-product. While the residual amount of 1,3-butadiene in both butane and isobutane ranged from 0.0 to <1 w/w %, levels were typically below 0.1 w/w %. However, in some cases, the levels of 1,3-butadiene were simply reported as “unknown.”

Major use patterns reported for butane and isobutane in the section 71 survey include its use as a propellant / blowing agent, fuel or fuel additive, solvent carrier, and formulation component. In terms of non-fuel uses, butane is used in various applications including insulating polyurethane foam, aerosol sprays and coatings, paint dyes and automotive spray waxes in which the concentration of butane can range up to 60 w/w %. Isobutane is used in consumer products such as cosmetic/beauty preparations, air freshener, cleaners, activators/primers and various coatings in which the concentration of isobutane may range up to 70 w/w %. The presence of residual 1,3-butadiene in products containing butane and isobutane is not due to intentional addition of 1,3-butadiene.

To estimate potential risk to human health from 1,3-butadiene in consumer products containing butane or isobutane, a modelled exposure estimate to 1,3-butadiene from hairspray (product composition of 70% isobutane containing 0.1 w/w % 1,3-butadiene) was compared to cancer potency estimates and benchmark concentrations derived for carcinogenicity and reproductive toxicity of 1,3-butadiene. The hairspray scenario was chosen because it represented the upper-end of the isobutane concentration in a propellant, the typical upper-bound levels of 1,3-butadiene in the isobutane, and the most frequent use pattern. This comparison resulted in exposure potency indexes which indicate that the priority for investigation of options to reduce potential exposure to 1,3-butadiene from this source is low to moderate. Some consumer products contain slightly higher levels of 1,3-butadiene in butane or isobutane (up to < 1.0 w/w %). These products would contribute to overall exposure to 1,3-butadiene. Also, there is potential for multiple products to be used successively, increasing exposure to 1,3-butadiene.

Comparing this modelled exposure estimate for consumer product use to data from Canadian indoor air studies, estimated concentrations of 1,3-butadiene attributable to consumer product use are 50 times lower than the average indoor levels measured in “non-smoking” homes. Other potential indoor air sources include fuel combustion (e.g. natural gas, oil or wood), and infiltration of automobile exhaust. In addition, higher levels of 1,3-butadiene are found in “smoking” homes. Therefore, exposure to 1,3-butadiene from consumer products that contain butane and isobutane, including in multiple-use scenarios, should be considered in relation to ongoing risk management activities for 1,3-butadiene.

Since the PSL 2 determination that 1,3-butadiene poses a low ecological risk, no data have come to the attention of Environment Canada to suggest an increase in its ecotoxicological effects. The quantities of 1,3-butadiene considered under the PSL 2 assessment surpass the quantities identified in the section 71 survey of 1,3-butadiene as a trace contaminant in butane and isobutane. Previously unconsidered releases of 1,3-butadiene into the environment (e.g. from the use of butane as an aerosol propellant) are not expected to add significantly to the exposure to aquatic or terrestrial organisms. It is therefore concluded that the ecological risks associated with concentrations of 1,3-butadiene in butane and isobutane in Canada are low.

Recommendation

Based on the information available, it is concluded that the exposure to 1,3-butadiene from the uses of butane and isobutane identified in this investigation should be considered in relation to ongoing risk management activities undertaken for 1,3-butadiene under CEPA 1999. Risk management activities for 1,3-butadiene are in place and will be revisited in the context of any new exposure information available.

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

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with extensible hypertext markup language (XHTML 1.0 Strict).