Vol. 147, No. 27 — July 06, 2013

DEPARTMENT OFTHE ENVIRONMENT

DEPARTMENT OF HEALTH

Publication after Screening Assessment of Substances — Batch 12

Publication after screening assessment of a substance — Benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]- (mitotane), CAS (see footnote 1) No. 53-19-0 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]- is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

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

Whereas it is proposed to conclude that the substance 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 propose to recommend to His Excellency the Governor in Council that the substance be added to Schedule 1 of the Act.

Notice is furthermore given that the Ministers of the Environment and of Health have released a risk management scope document for this substance to initiate discussions with stakeholders on the development of a proposed risk management approach document.

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), substances@ec.gc.ca (email).

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

DAVID MORIN
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 Report of Benzene,
1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]-, Chemical Abstracts Service Registry No. 53-19-0; this substance will be referred to by its common name, mitotane, in this assessment. Mitotane was identified as a high priority for screening assessment and included in the Challenge initiative under the Chemicals Management Plan because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

Mitotane 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.

Mitotane is an organic substance registered for use in Canada as a chemotherapeutic agent for the treatment of adrenal cancer. The substance is not naturally occurring and is not manufactured in Canada. However, between 100 and 1 000 kg of mitotane were imported into Canada in 2005. Mitotane was not imported in 2006 above the reporting threshold of 100 kg nor used above the reporting threshold of 1 000 kg. However, an estimated 93 kg, deemed representative of a typical year, were used in 2007 in Canada. The use of mitotane as a chemotherapeutic agent suggests that it could be released into the Canadian environment. Additionally, mitotane may be formed upon the degradation of a component of the end-use products of dichlorodiphenyltrichloroethane (DDT) and dicofol. Mitotane is also present at low levels as a residue in DDT formulation. Residues of both DDT and dicofol pesticides may still be found in soil and sediment although there are no longer end-use products containing these substances registered for use in Canada.

Based on mitotane’s chemotherapeutic use, a small amount of this substance may be released to wastewater systems. It is expected that most of the total quantity of mitotane currently present in the environment is the result of historical use of the pesticides dicofol and DDT. Mitotane has low solubility in water, has minimal volatility and has a tendency to partition to particles and to the lipids of organisms due to its hydrophobic nature. For these reasons, mitotane may still be predominantly found in soil, and to a lesser extent, in sediment. It is expected to be present in small proportions in water and air.

Based on its physical and chemical properties, mitotane is not expected to degrade rapidly in the environment. It is expected to be persistent in air, water, soil and sediments. Mitotane also has the potential to bioaccumulate in aquatic organisms and may biomagnify in freshwater piscivorous food chains; such accumulation is unlikely in birds or mammals, however, because of their enhanced metabolic capacities. The substance has been determined to meet both the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, analogue and modelled aquatic toxicity data indicate that the substance is highly hazardous to aquatic organisms.

There are long-term risks associated with persistent and bioaccumulative substances, which cannot, at present, be reliably predicted. Since accumulations of persistent and bioaccumulative substances may be widespread and are difficult to reverse, a conservative response to uncertainty is justified. However, it is acknowledged that the level of concern for a persistent and bioaccumulative substance is dependant on the rate and nature of releases to the environment. While limited quantities of mitotane are used in Canada, a relatively large proportion of the amount used may be released at a small number of sites. Therefore, the concentration of this substance could be high and quantitative risk estimates have relevance. The comparison of estimated levels of mitotane in lakes and rivers receiving wastewater system effluent with a level expected to cause harm to sensitive aquatic organisms indicates potential for ecological harm.

Based on the empirical health effects for mitotane, the adrenal glands are expected to be the target tissue for humans. Margins between conservative upper bounding estimates of exposure to mitotane from environmental media and the lowest-observed-effect level in experimental animals are considered adequate to address uncertainties in the health effects and exposure databases.

Based on the information available, it is proposed to conclude that mitotane meets the criteria in paragraph 64(a) of CEPA 1999, as it 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. However, mitotane does not meet the criteria under paragraph 64(b) of CEPA 1999, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends. It is also proposed to conclude that mitotane does not meet the criteria in paragraph 64(c) of CEPA 1999, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Proposed conclusion

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

In addition, it is proposed to conclude that Benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]- is persistent and bioaccumulative in accordance with the Regulations and its presence in the environment results primarily from human activity.

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

Publication after screening assessment of a substance — 2,4,11,13-Tetraazatetradecanediimidamide, N,N″-bis(4-chlorophenyl)-3,12-diimino-, diacetate (chlorhexidine acetate), CAS No. 56-95-1 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 2,4,11,13-Tetraazatetradecanediimidamide, N,N″-bis(4-chlorophenyl)-3,12-diimino-, diacetate 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 the substance pursuant to section 74 of the Act is annexed hereby;

And whereas it is proposed to conclude that the substance meets one or more of the criteria set out in section 64 of the Act;

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

Notice is furthermore given that the Ministers of the Environment and of Health 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), substances@ec.gc.ca (email).

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

DAVID MORIN
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 Report of 2,4,11,13-Tetraazatetradecanediimidamide, N,N″-bis(4-chlorophenyl)-3,12-diimino-, diacetate

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 2,4,11,13-Tetraazatetradecanediimidamide, N,N″-bis(4-chlorophenyl)-3,12-diimino-, diacetate, Chemical Abstracts Service Registry No. 56-95-1; this substance will be referred to by its common name, chlorhexidine acetate, in the assessment. This substance was identified as a high priority for screening assessment and included in the Challenge initiative under the Chemicals Management Plan because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

Chlorhexidine acetate was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed for categorization of substances on the Domestic Substances List.

Chlorhexidine acetate is an organic substance that is used primarily as a disinfectant and antibacterial agent. The substance does not naturally occur in the environment. As a result of industry surveys conducted pursuant to section 71 of CEPA 1999, chlorhexidine acetate was not reported to be manufactured in Canada in 2005 or 2006. One company reported importing a total of 600 kg into the country in 2006.

Based on reported industrial and commercial/consumer use patterns and certain assumptions, chlorhexidine acetate is predicted to be released in wastewater (before treatment; about 1% from industrial use), to surface water (up to 43% from consumer/ commercial uses), to soil (up to 43% via the application of biosolids and manure), and through waste disposal (incineration and landfill; ~10%). Chlorhexidine acetate is a salt and dissociates in water to produce the acetate counterion and chlorhexidine. Chlorhexidine is a strong base and is expected to protonate in water at pH 6 to 9, such that virtually all (~99%) of the substance will exist with two of its amine groups positively charged.

Experimental and predicted data suggest that chlorhexidine acetate will persist in water, soil and sediment. Its physical and chemical properties suggest that chlorhexidine acetate has a low bioaccumulation potential. Experimental acute toxicity data for chlorhexidine acetate and chlorhexidine show that they have the potential to cause acute harm to aquatic organisms at low concentrations.

For this draft Screening Assessment, a realistic worst-case exposure scenario was selected in which an industrial operation discharges chlorhexidine acetate into the aquatic environment through a wastewater treatment plant. Release and exposure levels of chlorhexidine acetate were estimated based on quantities imported in 2006. The predicted environmental concentration in water of this substance was above the predicted no-effect concentration for sensitive aquatic organisms.

Based on the ecological information available, it is proposed to conclude that chlorhexidine acetate meets the criteria in paragraph 64(a) of CEPA 1999, as it 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. However, chlorhexidine acetate does not meet the criteria under paragraph 64(b) of CEPA 1999, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends. It is also proposed to conclude that this substance meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

General population exposure from environmental media is expected to be low. Exposure from the diet is not expected. Exposure to the general population can occur from use of products containing this substance. No evidence of carcinogenicity or genotoxicity were observed in the available health effects data on chlorhexidine acetate and chlorhexidine gluconate, and a threshold approach is used to characterize risk to human health. The margins between upper-bounding estimates of exposure from environmental media and from use of consumer products and levels associated with effects in experimental animals are considered adequate to address uncertainties in the health effects and exposure databases. Based on available information for human health considerations, it is proposed to conclude that chlorhexidine acetate does not meet the criteria in paragraph 64(c) of CEPA 1999, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Proposed conclusion

Based on the information available, it is proposed to conclude that 2,4,11,13-Tetraazatetradecanediimidamide, N,N″-bis(4-chlorophenyl)-3,12-diimino-, diacetate meets one or more criteria set out in section 64 of CEPA 1999.

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

Publication after screening assessment of a substance — 1- Naphthalenepropanol, α-ethenyldecahydro-2-hydroxy-α,2,5,5,8a-pentamethyl-,[1R-[1α(R*),2ß,4aß,8aα]]- (sclareol), CAS No. 515-03-7 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 1- Naphthalenepropanol, α-ethenyldecahydro-2-hydroxy-α,2,5,5,8a-pentamethyl-,[1R-[1α(R*),2ß,4aß,8aα]]- 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 the substance pursuant to section 74 of the Act is annexed hereby;

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

And whereas the Minister of the Environment intends to amend the Domestic Substances List, under subsection 87(3) of the Act, to indicate that subsection 81(3) thereof applies with respect to this substance,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on the substance 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), substances@ec.gc.ca (email).

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

DAVID MORIN
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 1- Naphthalenepropanol, α-ethenyldecahydro-2-hydroxyα,2,5,5,8a-pentamethyl-,[1R-[1α(R*),2ß,4aß,8aα]]-

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 1- Naphthalenepropanol, α-ethenyldecahydro-2-hydroxy-α,2,5,5,8α-pentamethyl-,[1R-[1α(R*),2β,4αβ,8αα]]-, Chemical Abstracts Service Registry No. 515-03-7; this substance will be referred to by its common name, sclareol. Sclareol was identified as a high priority for screening assessment and included in the Challenge initiative under the Chemicals Management Plan because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada. The substance, sclareol, was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed for categorization of substances on the Domestic Substances List.

Sclareol is naturally produced as a component in the essential oil of several genera (e.g. Salvia and Stachys) in the mint family, Lamiaceae. The essential oil containing sclareol may be produced by plants to protect themselves from pathogens (i.e. bacteria and/or fungi), foraging herbivores and/or influence the growth of neighbouring plants. Sclareol has been isolated in several plant species such as Salvias clarea, Salvia officinalis, Salvia judaica Boiss., Salvia palaestina Benth, Juniperus phoenicea L., Cistus creticus L., Astragalus brachystachys DC., and some 25 tobacco species, such as Nicotiana glutinosa L. and Nicotiana tabacum L.

In Canada, sclareol is not reported to be imported or manufactured above the 100 kg reporting threshold or used above the 1 000 kg threshold by any single company for the reporting years 2005 and 2006; however, a total estimated quantity of 76 to 1 350 kg sclareol is currently used in Canada per year, and this was taken into consideration for the assessment. Sclareol is a component of the clary sage essential oil, which was reported to be present in cosmetics, aromatherapy products, flavouring additives, and fragrances, including some personal care products, in Canada.

It is expected that sclareol, when produced by plants, will likely be degraded by soil bacteria or other fungal species, as a number of studies have shown that soil micro-organisms are capable of metabolizing sclareol. However, when the essential oil containing sclareol is chemically extracted from these plants and incorporated into cosmetics, including personal care products, down-the-drain releases are likely to occur via wastewater treatment plant effluent into the aquatic environment, where degradation is expected to occur much more slowly.

Sclareol has low water solubility and has a tendency to partition to sediments if released to surface waters. Based on its physical and chemical properties, modelled data and a limited amount of experimental data, sclareol is expected to be persistent in water and sediment. Modelled data relating to its partitioning between octanol and water indicate that sclareol has a high potential to accumulate in the lipid tissues of organisms. The substance meets the persistence criteria and the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. Modelled toxicity data for sclareol suggest that the substance can cause acute harm to aquatic organisms. Experimental microbial toxicity data also suggest that sclareol causes harm to bacteria and fungi.

Based on the relatively small amounts known to be in commerce in Canada and its uses which can lead to disperse releases to the environment, ecological exposure to sclareol is expected to be low. Therefore, it is proposed to conclude that sclareol is not currently causing ecological harm in Canada. Based on the information available, it is proposed to conclude that sclareol does not meet the criteria in paragraphs 64(a) and (b) of CEPA 1999, as it 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 a danger to the environment on which life depends.

Based on available information, exposure of the general population to sclareol is expected to be negligible given the low reports of use of sclareol in Canada in 2006. The general population is expected to be exposed predominantly via the dermal route from the presence of sclareol, a component of clary sage essential oil, in cosmetics, including some personal care products. Based on the limited health effects information available, sclareol was not considered to have high hazard potential. Based on a comparison of conservative upper-bounding estimates of dermal exposure to sclareol from the presence of clary sage essential oil in cosmetics and a no-observed-adverse-effect level in experimental animals, the resulting margins of exposure were considered adequate to address uncertainties in the health effects and exposure databases. Based on the available information, it is proposed to conclude that sclareol does not meet the criteria in paragraph 64(c) of CEPA 1999, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Proposed conclusion

Based on the information available, it is proposed to conclude that 1- Naphthalenepropanol, α-ethenyldecahydro-2-hydroxy-α,2,5,5,8a-pentamethyl-,[1R-[1α(R*),2ß,4aß,8aα]]- does not meet any of the criteria set out in section 64 of CEPA 1999.

As sclareol is listed on the Domestic Substances List, it is not subject to declaration under the New Substance Notification Regulations (Chemicals and Polymers). However, given its persistence, bioaccumulation potential and toxicity, there is concern that new activities that have not been identified or assessed under CEPA 1999 could lead to this substance meeting the criteria set out in section 64 of the Act. Therefore, it is recommended to amend the Domestic Substances List, under subsection 87(3) of the Act, to indicate that subsection 81(3) of the Act applies with respect to this substance, so that any significant new activity is declared and undergoes ecological and human health risk assessments before the substance is imported, manufactured or used for the significant new activity.

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 — Benzenamine, 4,4′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis-, CAS No. 13080-86-9 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Benzenamine, 4,4′-[(1-methylethylidene)bis (4,1-phenyleneoxy)]bis- 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 the substance pursuant to section 74 of the Act is annexed hereby;

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

And whereas the Minister of the Environment intends to amend the Domestic Substances List, under subsection 87(3) of the Act, to indicate that subsection 81(3) thereof applies with respect to this substance,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on the substance 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), substances@ec.gc.ca (email).

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

DAVID MORIN
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 Report of Benzenamine,
4,4′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis-

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 Benzenamine, 4,4′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis-, Chemical Abstracts Service Registry No. 13080-86-9. This substance will be referred to as BAPP in the assessment. This substance was identified as a high priority for screening assessment and included in the Challenge initiative under the Chemicals Management Plan because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance BAPP was not considered to be a high priority for assessment of potential risks to human health, based upon application of the exposure and hazard tools developed for categorization of substances on the Domestic Substances List.

The substance BAPP is an organic substance that is used in Canada as a chemical intermediate in the manufacture of highly thermo-oxidative resistant polymer resins. The substance is not naturally occurring in the environment. In 2006, 250 kg of BAPP were imported into Canada for use mainly as a low-concentration additive in a corrosion inhibiting structural adhesive bonding primer for aircraft parts. More recent information shows that the quantity of BAPP in commerce in Canada increased to approximately 500 kg in 2010. The uses of this substance indicate that it could be released into the Canadian environment.

Based on reported use patterns and certain assumptions, most of the substance (66.5%) is sprayed onto plane parts and chemically transformed after subsequent curing. Some proportions that do not reach plane parts are estimated to be released to sewer following treatment at a hazardous waste treatment facility (4.5%), to air (1.5%) and to landfill/incineration (27.5%). BAPP has low solubility in water, negligible volatility and a tendency to partition to particles and lipids of organisms because of its hydrophobic nature. For these reasons, this substance is expected to ultimately be found mostly in sediments or in soil depending on the medium where it is released. It is not expected to be significantly present in the other media. It is also not expected to be subject to long-range atmospheric transport.

Based on the results of structure-activity relationship predictions, BAPP is not expected to degrade quickly in the environment. It is persistent in water, soil and sediments. This substance also has the potential to accumulate in organisms and may biomagnify in trophic food chains. BAPP has been determined to meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, modelled acute and chronic aquatic toxicity values indicate that the substance is highly hazardous to aquatic organisms. It has also been identified as having a strong estrogenic receptor binding potential.

Based on the small amount of BAPP imported into Canada, its use patterns and the handling and disposal practices currently in place, ecological exposure to this substance in Canada resulting from commercial activity is expected to be low. Therefore, it is proposed that BAPP does not meet the criteria in paragraphs 64(a) and (b) of CEPA 1999, as it 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.

Very little empirical health effects information was identified for BAPP. The outputs of quantitative structure-activity relationship predictions indicate potential hazardous properties (i.e. genotoxicity, carcinogenicity). Exposure of the general population to BAPP through environmental media and food is expected to be negligible. General population exposure to BAPP from use of consumer products is not expected. As exposure to the general population through environmental media in Canada is expected to be negligible, the risk to human health is considered to be low. Based on available information for human health considerations, it is proposed to conclude that BAPP does not meet the criteria in paragraph 64(c) of CEPA 1999, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Proposed conclusion

Based on the information available, it is proposed to conclude that Benzenamine, 4,4′-[(1-methylethylidene)bis (4,1-phenyleneoxy)]bis- does not meet any of the criteria set out in section 64 of CEPA 1999.

As BAPP is listed on the Domestic Substances List, it is not subject to declaration under the New Substance Notification Regulations (Chemicals and Polymers). However, given its high persistence, bioaccumulation potential and inherent toxicity, there is concern that new activities that have not been identified or assessed under CEPA 1999 could lead to this substance meeting the criteria set out in section 64 of the Act. Therefore, it is recommended to amend the Domestic Substances List, under subsection 87(3) of the Act, to indicate that subsection 81(3) of the Act applies with respect to this substance, so that any significant new activity is declared and undergoes ecological and human health risk assessments before the substance is imported, manufactured or used for the significant new activity.

The draft Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). Footnote 1
 The Chemical Abstracts Service (CAS) Registry Number is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.