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Final Screening Assessment for 52 Substances with High Hazard Potential on the Domestic Substances List

Chemical Abstracts Service Registry Numbers

55-18-5, 59-88-1, 60-35-5, 62-50-0, 62-55-5, 66-27-3, 75-25-2, 76-01-7, 78-88-6, 79-00-5, 79-16-3, 94-58-6, 96-09-3, 96-18-4, 100-63-0, 101-61-1, 106-87-6, 110-88-3, 115-28-6, 116-14-3, 122-60-1, 123-39-7, 123-73-9, 131-18-0, 131-52-2, 135-20-6, 136-35-6, 141-90-2, 331-39-5, 492-80-8, 569-61-9, 591-78-6, 593-60-2, 606-20-2, 615-28-1, 823-40-5, 1120-71-4, 1694-09-3, 3296-90-0, 4170-30-3, 10034-93-2, 10046-00-1, 13463-39-3, 13840-56-7, 15545-48-9, 24602-86-6, 25321-14-6, 25376-45-8, 26447-14-3, 39156-41-7, 55290-64-7, 103122-66-3

Environment Canada
Health Canada

May 2013

(PDF Format - 157 KB)

Table of Contents

Introduction

The Canadian Environmental Protection Act, 1999 (CEPA 1999) requires the Minister of the Environment and the Minister of Health to conduct screening assessments of substances that have met the categorization criteria set out in the Act to determine whether these substances present or may present a risk to the environment or human health.

Based on the information obtained through the categorization process, the Ministers identified a number of substances as priorities for further assessment. The 52 substances included in this assessment were identified as priorities because they had been identified as posing a high hazard to human health based on classifications by other national or international agencies for carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity. Fifteen of the 52 substances were also determined to meet categorization criteria for persistence or bioaccumulation, and inherent toxicity to human or non-human organisms (Environment Canada 2003, 2006), under subsection 73(1) of CEPA 1999.  Categorization results are presented in Appendix A and B.

Screening assessments focus on information critical to determining whether a substance meets the criteria as set out in section 64 of CEPA 1999[1]. Screening assessments examine scientific information and develop conclusions by incorporating a weight-of-evidence approach and precaution.

The Ministers of the Environment and of Health have conducted this screening assessment for these substances. The critical information and considerations upon which the assessment is based are summarized below. Since the publication of the draft assessment report, additional information was received on thiophanate-methyl (CAS Registry No. 23564-05-8), which indicates that is being used in Canada. As a result, this substance has since been removed from the assessment and will be considered for further assessment in the future.

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Summary of Information Used as Basis for this Screening Assessment

To establish whether certain substances were currently being manufactured in or imported into Canada, a survey was conducted by issuing a Notice with Respect to Selected Substances Identified as Priority for Action pursuant to paragraphs 71(1)(a) and (b) of CEPA 1999. The Notice was published in Part I of the Canada Gazette on March 4, 2006 (Canada 2006). The 14 substances from that survey being considered in this assessment are listed in Appendix A.

An additional survey was conducted by issuing a Notice with Respect to Certain Inanimate Substances (Chemicals) on the Domestic Substances List pursuant to paragraphs 71(1)(b) of CEPA 1999. The Notice was published in Part I of the Canada Gazette on October 3, 2009 (Canada 2009).  The 38 substances from that survey being considered in this assessment are listed in Appendix B.

In response to these notices, there were no reports of industrial activity (import or manufacture) with respect to these substances in Canada above the reporting threshold of 100 kg for the relevant reporting year. These results indicate that currently these substances are not in use above the specified reporting threshold. Entry characterization consisted of additionally searching for information on releases and sources of the substance in relevant databases, particularly to identify direct exposure potential to the general population (CNS 2010; Canada [1978]; DPD 2010; NHPID 2010; LNHPD 2010; EAFUS 2010; HPD 2010; HSDB c1993-2008). Searches for these substances were conducted up to November 2010, and no information was found on current uses or releases of these substances in Canada. Therefore, the likelihood of exposure to these substances in Canada resulting from commercial activity is low and hence the potential risks to human health or the environment are considered to be low.

Additional information obtained and assessed following categorization indicates a lack of any significant commercial activity for these substances. Consequently, no further collection or analysis of information relevant to the health and/or environmental effects of these substances has been conducted. Therefore, the decisions on human health hazard potential and persistence, bioaccumulation and inherent toxicity properties made during categorization remain unchanged.

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Conclusion

Based on available information, and until new information is received indicating that these 52 substances are entering, or may enter the environment, from commercial activity or from other sources, it is concluded that they do not meet any of the criteria as set out in section 64 of CEPA 1999.

As substances listed on the DSL, import and manufacture of these substances in Canada are not currently subject to notification under subsection 81(1). Given their potential high hazard for human health, there is concern that new activities for the above substances which have not been identified or assessed under CEPA, 1999 could lead to the substances meeting the criteria set out in section 64 of CEPA, 1999. Therefore, the Domestic Substances List will be amended, under subsection 87(3) of the Act, to indicate that the above 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 any of these substances in quantities  greater than 100 kg/year is notified and will undergo ecological and human health risk assessments as specified in section 83 of the Act, prior to the substance being considered for introduction into Canada.

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References

Canada. [1978]. Food and Drug Regulations, C.R.C., c. 870, s. B.16.100.

Canada. 1999. Canadian Environmental Protection Act, 1999. S.C., 1999, c. 33, Canada Gazette, Part III. Vol. 22, No. 3.

Canada. 2000. Canadian Environmental Protection Act: Persistence and Bioaccumulation Regulations, P.C. 2000-348, 23 March, 2000, SOR/2000-107, Canada Gazette, Part II, Vol. 134, No. 7.

Canada, Dept. of the Environment, Dept. of Health. 2006. Canadian Environmental Protection Act, 1999: Notice with respect to selected substances identified as priority for action. Canada Gazette, Part I, Vol. 140, No. 9.

Canada, Dept. of the Environment, Dept. of Health. 2009. Canadian Environmental Protection Act, 1999: Notice with respect to certain inanimate substances (chemicals) on the Domestic Substances List. Canada Gazette, Part I, Vol. 143, No. 40.

[CNS] Cosmetic Notification System [proprietary database]. 2010. Ottawa (ON): Health Canada. [cited 2010 October]

[DPD] Drug Products Database Online Query [database on the Internet]. 2010. Ottawa (ON): Therapeutic Products Directorate, Health Canada. [cited 2010 November].

[EAFUS] Everything Added to Food in the United States [Internet]. 2010. U.S. Food and Drug Administration; [cited 2010 June].

Environment Canada. 2006. CEPA DSL Categorization Overview and Results [CD-ROM]. Gatineau (QC): Environment Canada, Existing Substances Division. Available on request.

[ESIS] European Chemical Substances Information System [database on the Internet]. c1995-2010. European Chemicals Bureau (ECB). [cited 2010 October].

Health Canada.  Guidelines for Canadian Drinking Water Quality - Supporting Documentation, Part 1 – Approach to Derivation of Drinking Water Guidelines, February 1995, Appendix A.

[HPD]. Household Products Database [database on the internet]. 2010. U.S. Department of Health & Human Services; [cited 2010 June].

[HSDB] Hazardous Substances Data Bank [database on the internet]. c1993-2008. United States National Library of Medicine, National Institutes of Health; [cited 2010 June].

[IARC] International Agency for Research on Cancer. 2010. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. [cited 2010 October].

[LNHPD] Licensed Natural Health Products Database [database on the internet]. 2010. Health Canada, Government of Canada; [Accessed 2010-09-20,21].

[NHPID] Natural Health Products Ingredients Database [database on the internet]. 2010. Health Canada, Government of Canada; [Accessed 2010-09-20,21].
 
[NTP]. National Toxicology Program Reports on Carcinogens. 2010. US Department of Health and Human Services. [cited 2010 October].

[PMRA]. Pest Management Regulatory Agency, Product Information Search [database on the internet]. 2010. Health Canada, Government of Canada; [cited 2010 November].

U.S. EPA. Risk Assessment Guidelines of 1986.  EPA/600/8-87/045, August 1987, Office of Health and Environmental Assessment, US EPA, Washington DC.

U.S. EPA. Guidelines for Carcinogen Risk Assessment (2005). U.S. Environmental Protection Agency, Washington, DC, EPA/630/P-03/001F, 2005.

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Appendix A: Categorization Criteria

Appendix A: Categorization results for 14 substances determined to be no longer in commercial use in Canada above the specified reporting threshold from the Notice with Respect to Selected Substances Identified as Priority for Action pursuant to paragraphs 71(1)(a) and (b) of CEPA 1999, published in Part I of the Canada Gazette on March 4, 2006 (Canada 2006)
CAS RN[1]DSL NameClassified for Carcino-genicity[2]Classified for Develop-mental Toxicity[2]Classified for Genotoxicity[2]Classified for Reproductive Toxicity[2]PersistentBioaccumulativeInherently Toxic to aquatic organismsMeets s.73 criteria[3]
55-18-5Ethanamine, N-ethyl-N-nitroso-X       
62-50-0Methanesulfonic acid, ethyl esterX       
66-27-3Methanesulfonic acid, methyl esterX       
79-16-3Acetamide, N-methyl- X      
94-58-61,3-Benzodioxole, 5-propyl-X       
115-28-6Bicyclo[2.2.1]hept-5-ene-2,3-dicarboxylic acid, 1,4,5,6,7,7-hexachloro-X   X  X
123-39-7Formamide, N-methyl- X      
123-73-92-Butenal, (E)-X X     
331-39-52-Propenoic acid, 3-(3,4-dihydroxyphenyl)-X       
593-60-2Ethene, bromo-X       
615-28-11,2-Benzenediamine, dihydrochlorideX X     
25376-45-81,3-Benzenediamine, ar-methyl-X       
39156-41-71,3-Benzenediamine, 4-methoxy-, sulfate (1:1)X X     
55290-64-71,4-Dithiin, 2,3-dihydro-5,6-dimethyl-, 1,1,4,4-tetraoxideX       
[1] CAS RN – Chemical Abstracts Service Registry Number
[2] For more information on the criteria used to determine substance classifications, see Appendix C.
[3] Persistent or bioaccumulative and inherently toxic to human beings (based on carcinogenicity) or to non-human organisms (based on inherent toxicity to aquatic organisms).

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Appendix B: Categorization Criteria

Appendix B: Categorization results for 38 substances determined to be no longer in commercial use in Canada above the reporting threshold from the Notice with Respect to Certain Inanimate Substances (Chemicals) on the Domestic Substances List pursuant to paragraphs 71(1)(b) of CEPA 1999, published in Part I of the Canada Gazette on October 3, 2009 (Canada 2009).
CAS RN[1]DSL NameClassified for Carcino-genicity[2]Classified for Develop-mental Toxicity[2]Classified for Geno-toxicity[2]Classified for Repro-ductive Toxicity[2]PersistentBioaccu-mulativeInherently Toxic to aquatic organismsMeets section 73 criteria[3]
59-88-1Hydrazine, phenyl-, monohydrochlorideX X     
60-35-5AcetamideX       
62-55-5EthanethioamideX       
75-25-2Methane, tribromo-X   X  X
76-01-7Ethane, pentachloro-X   X  X
78-88-61-Propene, 2,3-dichloro-  X     
79-00-5Ethane, 1,1,2-trichloro-X[4]   X   
96-09-3Oxirane, phenyl-X   X  X
96-18-4Propane, 1,2,3-trichloro-X  XX  X
100-63-0Hydrazine, phenyl-X X     
101-61-1Benzenamine, 4,4’-methylenebis[N,N-dimethyl-X   X XX
106-87-67-Oxabicyclo[4.1.0]heptane, 3-oxiranyl-X       
110-88-31,3,5-Trioxane X      
116-14-3Ethene, tetrafluoro-X   X  X
122-60-1Oxirane, (phenoxymethyl)-X X     
131-18-01,2-Benzenedicarboxylic acid, dipentyl ester X X  X 
131-52-2Phenol, pentachloro-, sodium saltX   X XX
135-20-6Benzenamine, N-hydroxy-N-nitroso-, ammonium saltX       
136-35-61-Triazene, 1,3-diphenyl-X       
141-90-24(1H)-Pyrimidinone, 2,3-dihydro-2-thioxo-X       
492-80-8Benzenamine, 4,4’-carbonimidoylbis[N,N-dimethyl-X     X 
569-61-9Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, monohydrochlorideX       
591-78-62-Hexanone   X    
606-20-2Benzene, 2-methyl-1,3-dinitro-XXXXX  X
823-40-51,3-Benzenediamine, 2-methyl-X X     
1120-71-41,2-Oxathiolane, 2,2-dioxideX       
1694-09-3Benzenemethanaminium, N-[4-[[4-(dimethylamino)phenyl][4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-3-sulfo-, hydroxide, inner salt, sodium saltX   X  X
3296-90-01,3-Propanediol, 2,2-bis(bromomethyl)-X   X  X
4170-30-32-Butenal  X     
10034-93-2Hydrazine, sulfate (1:1)X   X XX
10046-00-1Hydroxylamine, sulfate (1:1) (salt)X   X XX
13463-39-3Nickel carbonyl (Ni(CO)4), (T-4)-XX  X XX
13840-56-7Boric acid (H3BO3), sodium salt X XX   
15545-48-9Urea, N’-(3-chloro-4-methylphenyl)-N,N-dimethyl-XX    X 
24602-86-6Morpholine, 2,6-dimethyl-4-tridecyl-XXXX XXX
25321-14-6Benzene, methyldinitro-X XXX  X 
26447-14-3Oxirane, [(methylphenoxy)methyl]-X XX     
103122-66-3Carbamic acid, [(2-methylpropoxy)thioxomethyl]-, ethyl esterX X     
[1] CAS RN – Chemical Abstracts Service Registry Number
[2] For more information on the criteria used to determine substance classifications, see Appendix C.
[3] Persistent or bioaccumulative and inherently toxic to human beings (based on carcinogenicity) or to non-human organisms (based on inherent toxicity to aquatic organisms).
[4] Identified after completion of categorization in 2006.

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Appendix C: Criteria Used for Obtaining Results From the Simple Hazard Tool

Carcinogenicity is determined by one or more of the following criteria:

European Community (ESIS c1995-2010)

Health Canada (Guidelines for Canadian Drinking Water Quality) (Health Canada 1995)

International Agency for Research on Cancer (IARC 2010)

National Toxicology Program (NTP 2010)

United States Environmental Protection Agency (US EPA) 1986 Carcinogenicity Guidelines (U.S. EPA 1987)

US EPA 2003 Carcinogenicity Guidelines (U.S. EPA 2003)

Developmental Toxicity is determined by one of the following criteria:

European Community (ESIS c1995-2010)

Genotoxicity is determined by one of the following criteria:

European Community (ESIS c1995-2010)

Reproductive Toxicity is determined by one of the following criteria:

European Community (ESIS c1995-2010)


Footnote

[1] A determination of whether one or more of the criteria of section 64 are met is based upon an assessment of potential risks to the environment and/or to human health associated with exposures in the general environment. For humans, this includes, but is not limited to, exposures from ambient and indoor air, drinking water, foodstuffs, and the use of consumer products. A conclusion under CEPA 1999 is not relevant to, nor does it preclude, an assessment against the hazard criteria specified in the Controlled Products Regulations, which is part of regulatory framework for the Workplace Hazardous Materials Information System [WHMIS] for products intended for workplace use. Similarly, a conclusion based on the criteria contained in section 64 of CEPA 1999 does not preclude actions being taken under other sections of CEPA 1999 or other Acts.
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