PBiT substances risk assessment and order amending the Domestic Substances List

The results of categorization indicate that there are 397 substances on the Domestic Substances List (DSL) that are Persistent, Bioaccumulative and inherently Toxic (PBiT) to non-human organisms, according to the categorization criteria. Preliminary research indicated that a high percentage of these substances may no longer be manufactured in or imported into Canada. To establish whether this was the case, surveys were conducted on these substances in 2001 and 2006 by issuing notices pursuant to paragraphs 71(1)(a) and (b) of the Canadian Environmental Protection Act, 1999 (CEPA 1999) in the Canada Gazette, Part I. There were no reports of industrial activity with respect to 148 of these PBiT substances, therefore the likelihood of exposure to these substances in Canada resulting from commercial activity was considered to be low. The draft screening assessment for these 148 PBiT substances and notice of intent to apply the Significant New Activity (SNAc) provisions were published in December 2006. Following the public comment period, the final screening assessment was published in April 2008, followed by an order applying the SNAc provisions to 145 substances in June 2008. Three of the initial 148 PBiT substances were no longer considered eligible for the application of the SNAc provisions, on the basis of new information received during the public comment period. Since then, as a result of new information, requirements under the SNAc provisions have been rescinded for 49 of these substances. The SNAc requirements on the remaining 96 of the 145 PBiT substances will be revised, as needed, under appropriate groups as part of the SNAc review.

Significant New Activity Notification risk assessment summary

One substance in this batch has been assessed for new activities notified through a Significant New Activity Notification (SNAN). One Significant New Activity Notification risk assessment summary has been published.

Rescinding requirements under the Significant New Activity provisions

In July 2017, the SNAc requirements for 32 substances included in the Aromatic Azo and Benzidine-based Substance Grouping were rescinded. These 32 substances were subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. These substances have since been included in the Certain Azo Disperse Dyes Subgroup, and the March 2017 assessment of that subgroup concluded that these substances are no longer of concern to the environment.  An order was published in the Canada Gazette, Part II: Vol. 151, No.14 – July 12, 2017 rescinding the requirements under the SNAc provisions of CEPA 1999 for these 32 substances.

In October 2016, the requirements for CAS RN 71720-89-3, CAS RN 83027-51-4, CAS RN 83027-52-5, CAS RN 90218-20-5, CAS RN 90459-02-2 and CAS RN 114910-04-2 were rescinded. These 6 substances were subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. These 6 substances have since been included in the Certain Azo Acid Dyes Subgroup, and the 2016 assessment of that subgroup concluded that CAS RN 71720-89-3, CAS RN 83027-51-4, CAS RN 83027-52-5, CAS RN 90218-20-5, CAS RN 90459-02-2 and CAS RN 114910-04-2 do not pose a risk to the environment or human health. An order was published in the Canada Gazette, Part II: Vol. 150, No. 21 - October 19, 2016 rescinding the requirements under the SNAc provisions of CEPA 1999 for these 6 substances.

In October 2016, the SNAc requirements for CAS RN 59709-10-3 were rescinded. CAS RN 59709-10-3 was subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. CAS RN 59709-10-3 has since been included in the Certain Azo Basic Dyes Subgroup, and the 2016 assessment of that subgroup concluded that CAS RN 59709-10-3 does not pose a risk to the environment or human health. An order was published in the Canada Gazette, Part II: Vol. 150, No. 21 - October 19, 2016 rescinding the requirements under the SNAc provisions of CEPA 1999 for this substance.

In October 2016, the SNAc requirements for Solvent Red 4 (CAS RN 2653-64-7), CAS RN 73528-78-6, CAS RN 85392-21-8, NANPAP (CAS RN 85005-63-6), and NAPNPA (CAS RN 94199-57-2) were rescinded. These 5 substances were subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. These 5 substances have since been included in the Certain Azo Solvent Dyes and Certain Monoazo Pigments subgroupings, and the 2016 assessments of those subgroupings concluded that Solvent Red 4 (CAS RN 2653-64-7), CAS RN 73528-78-6, CAS RN 85392-21-8, NANPAP (CAS RN 85005-63-6), and NAPNPA (CAS RN 94199-57-2) do not pose a risk to the environment or human health. An order was published in the Canada Gazette, Part II: Vol. 150, No. 21 - October 19, 2016 rescinding the requirements under the SNAc provisions of CEPA 1999 for these 5 substances.

In March 2015, the SNAc requirements for TDBD (CAS RN 1871-22-3) were rescinded. TDBD was subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. TDBD has since been included in the Certain Benzidine-based Dyes and Related Substances Subgroup, and the 2014 assessment of that subgroup concluded that TDBD does not meet the criteria for bioaccumulation or inherent toxicity to aquatic organisms. An order was published in the Canada Gazette, Part II: Vol. 149, No. 5 - March 11, 2015 rescinding the requirements under the SNAc provisions of CEPA 1999 for this substance.

In December 2014, the SNAc requirements for CPAOBP (CAS RN 78952-70-2) were rescinded. CPAOBP was subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. CPAOBP has since been included in the Certain Diarylide Yellow Pigments Subgroup, and the 2014 assessment of that subgroup concluded that CPAOBP does not meet the criteria for bioaccumulation or inherent toxicity to aquatic organisms. An order was published in the Canada Gazette, Part II: Vol. 148, No. 26 - December 17, 2014 rescinding the requirements under the SNAc provisions of CEPA 1999 for this substance.

In July 2014, the SNAc requirements for CAS RN 92-72-8, CAS RN 92-76-2 and CAS RN 135-63-7 were rescinded. These 3 substances were subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. A review and analysis of new information related to the 3 substances was undertaken, and the 2013 assessment concluded that these substances are no longer considered to meet categorization criteria for bioaccumulation or inherent toxicity. Therefore, future use of these substances is no longer considered a potential concern to the environment. An order was published in the Canada Gazette, Part II: Vol.148, No. 16 - July 30, 2014 rescinding the requirements under the SNAc provisions of CEPA 1999 for these 3 substances.

Aromatic Azo and Benzidine-based Substance Grouping

The following substances in this initiative have been included in the Aromatic Azo and Benzidine-based Substance Grouping under the Substance Groupings Initiative. As outlined in the notice of intent for this substance grouping, it was recognized that assessments and conclusions pertaining to some of the substances in this grouping may be subsequently updated as part of the subgroup assessment. The latest updates on the following substances can be found on the respective Aromatic Azo and Benzidine-based Substance Grouping pages.

List of "145 PBiT" substances included within the Aromatic Azo and Benzidine-based Substance Grouping
CAS RN Chemical substance Subgroup
1871-22-3 2H-Tetrazolium, 3,3'-(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[2,5-diphenyl-, dichloride (TDBD) Certain Benzidine-based Dyes and Related Substances
2537-62-4 Acetamide, N-[2-[(2-bromo-6-cyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]- Certain Azo Disperse Dyes
2653-64-7 Solvent Red 4 Certain Azo Solvent Dyes
3701-40-4 Acid Red 99 Benzidine-based Dyes and Related Substances
6368-72-5 Solvent Red 19 Certain Azo Solvent Dyes
6420-06-0 Direct Violet 28 Certain Benzidine-based Dyes and Related Substances
6465-02-7 Carbamic acid, [4-[[4-[(4-hydroxyphenyl)azo]-2-methylphenyl]azo]phenyl]-, methyl ester Certain Azo Disperse Dyes
15958-27-7 Propanenitrile, 3-[[4-[(4-nitrophenyl)azo]phenyl][2-[[(phenylamino)carbonyl]oxy]ethyl]amino]-
19745-44-9 Propanenitrile, 3-[4-[(5-nitro-2-thiazolyl)azo](2-phenylethyl)amino]-
24610-00-2 Benzonitrile, 2-[[4-[(2-cyanoethyl)(2-phenylethyl)amino]phenyl]azo]-5-nitro-
25150-28-1 Propanenitrile, 3-[[4-[(6,7-dichloro-2-benzothiazolyl)azo]phenyl]ethylamino]-
28824-41-1 Propanenitrile, 3-[[4-[(4,6-dibromo-2-benzothiazolyl)azo]phenyl]ethylamino]-
31030-27-0 Benzenamine, 4-[(2-chloro-4-nitrophenyl)azo]-N-ethyl-N-(2-phenoxyethyl)-
33979-43-0 Propanenitrile, 3-[[2-(acetyloxy)ethyl][4-[(5,6-dichloro-2-benzothiazolyl)azo]phenyl]amino]- Certain Azo Disperse Dyes
41362-82-7 Propanenitrile, 3-[[4-[(5,6-dichloro-2-benzothiazolyl)azo]phenyl]methylamino]-
42852-92-6 Acetamide, N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-4-methoxy-5-[(phenylmethyl)-2-propenylamino]phenyl]-
55252-53-4 Acetamide, N-[2-[(2-cyano-6-iodo-4-nitrophenyl)azo]-5-(diethylamino)phenyl]-
56532-53-7 Acetamide, N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(dipropylamino)phenyl]-
59709-10-3 Pyridinium, 1-[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl]-, acetate Certain Azo Basic Dyes
61799-13-1 3-Pyridinecarbonitrile, 5-[(2-cyano-4-nitrophenyl)azo]-2-[(2-hydroxyethyl)amino]-4-methyl-6-[[3-(2-phenoxyethoxy)propyl]amino]- Certain Azo Disperse Dyes
63133-84-6 1(2H)-Quinolineethanol, 6-[(2-chloro-4,6-dinitrophenyl)azo]-3,4-dihydro-2,2,4,7-tetramethyl-
63134-15-6 Disperse Red 338
63281-10-7 3-Pyridinecarbonitrile, 5-[[2-chloro-4-(methylsulfonyl)phenyl]azo]-4-methyl-2,6-bis[[3-(2-phenoxyethoxy)propyl]amino]- Certain Azo Metal Complexes and Other Azo Substances
63833-78-3 3-Pyridinecarbonitrile, 5-[(2-cyano-4-nitrophenyl)azo]-6-[(2-hydroxyethyl)amino]-4-methyl-2-[[3-(2-phenoxyethoxy)propyl]amino]- Certain Azo Disperse Dyes
68214-66-4 Carbamic acid, [2-[(2-chloro-4-nitrophenyl)azo]-5-(diethylamino)phenyl]-, 2-ethoxyethyl ester
68400-36-2 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6-[[4'-[(4-hydroxyphenyl)azo]-3,3'-dimethyl[1,1'-biphenyl]-4-yl]azo]-3-[(4-nitrophenyl)azo]-, disodium salt (NAAHD) Certain Benzidine-based Dyes and Related Substances
68516-64-3 Propanenitrile, 3-[[2-(acetyloxy)ethyl][4-[(2-chloro-4-nitrophenyl)azo]-3-methylphenyl]amino]- Certain Azo Disperse Dyes
68877-63-4 Acetamide, N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-[(2-cyanoethyl)-2-propenylamino]-4-methoxyphenyl]-
70210-08-1 Disperse Red 151
70660-55-8 1-Naphthalenamine, 4-[(2-bromo-4,6-dinitrophenyl)azo]-N-(3-methoxypropyl)-
71720-89-3 2-Naphthalenesulfonic acid, 5-[[4-(4-cyclohexylphenoxy)-2-sulfophenyl]azo]-6-[(2,6-dimethylphenyl)amino]-4-hydroxy-, disodium salt Certain Azo Acid Dyes
72828-63-8 Benzonitrile, 2-[[4-[[2-(acetyloxy)ethyl]butylamino]-2-methylphenyl]azo]-3-bromo-5-nitro- Certain Azo Disperse Dyes
72828-64-9 Disperse Blue 287
73003-64-2 2,4,10-Trioxa-7-azaundecan-11-oic acid, 7-[4-[(2,6-dichloro-4-nitrophenyl)azo]-3-methylphenyl]-3-oxo-, methyl ester
73398-96-6 Disperse Brown 21
73528-78-6 3-Pyridinecarbonitrile, 5-[[4-[(2,6-dichloro-4-nitrophenyl)azo]-2,5-dimethoxyphenyl]azo]-2,6-bis[(2-methoxyethyl)amino]-4-methyl- Certain Azo Solvent Dyes
78952-70-2 Butanamide, 2-[[3,3'-dichloro-4'-[[1-[[(2-chlorophenyl)amino]carbonyl]-2-oxopropyl]azo][1,1'-biphenyl]-4-yl]azo]-N-(2,4-dimethylphenyl)-3-oxo-(CPAOBP) Certain Diarylide Yellow Pigments
79542-46-4 Disperse Red 349 Certain Azo Disperse Dyes
83027-52-5 1,7-Naphthalenedisulfonic acid, 6-[[2-(2-cyclohexylphenoxy)phenyl]azo]-4-[[(2,4-dichlorophenoxy)acetyl]amino]-5-hydroxy-, disodium salt Certain Azo Acid Dyes
83027-51-4 1,7-Naphthalenedisulfonic acid, 6-[[2-(4-cyclohexylphenoxy)phenyl]azo]-4-[[(2,4-dichlorophenoxy)acetyl]amino]-5-hydroxy-, disodium salt
83249-47-2 Acetamide, N-[2-[(2-bromo-6-cyano-4-nitrophenyl)azo]-5-(dipropylamino)phenyl]- Certain Azo Disperse Dyes
83249-49-4 Benzonitrile, 3-bromo-2-[[4-(diethylamino)-2-methylphenyl]azo]-5-methyl-
83249-53-0 Methanesulfonamide, N-[2-[(2-bromo-6-cyano-4-methylphenyl)azo]-5-(diethylamino)phenyl]-
83249-54-1 Methanesulfonamide, N-[2-[(2-bromo-6-cyano-4-methylphenyl)azo]-5-(dipropylamino)phenyl]-
85005-63-6 2-Naphthalenecarboxamide, 4-[(2,4-dinitrophenyl)azo]-3-hydroxy-N-phenyl- (NANPAP) Certain Monoazo Pigments
85392-21-8 3-Pyridinecarbonitrile, 5-[[2-chloro-4-(phenylazo)phenyl]azo]-2,6-bis[(3-methoxypropyl)amino]-4-methyl- Certain Azo Solvent Dyes
90218-20-5 Benzenesulfonic acid, 5-amino-2,4-dimethyl-, diazotized, coupled with diazotized 2,4-, 2,5-and 2,6-xylidine and 4-[(2,4-dihydroxyphenyl)azo]benzenesulfonic acid, sodium salts Certain Azo Acid Dyes
90459-02-2 2,7-Naphthalenedisulfonic acid, 5-amino-4-hydroxy-3-[[6-sulfo-4-[(4-sulfo-1-naphthalenyl)azo]-1-naphthalenyl]azo]-, diazotized, coupled with diazotized 4-nitrobenzenamine and resorcinol, potassium sodium salts
90729-40-1 3-Pyridinecarbonitrile, 1-butyl-5-[[4-(4-chlorobenzoyl)-2-nitrophenyl]azo]-1,2-dihydro-6-hydroxy-4-methyl-2-oxo- Certain Azo Disperse Dyes
94199-57-2 2-Naphthalenecarboxamide, N-(2-ethoxyphenyl)-3-hydroxy-4-[(2-nitrophenyl)azo]- (NAPNPA) Certain Monoazo Pigments
127126-02-7 Propanenitrile, 3-[[2-(acetyloxy)ethyl][4-[(6,7-dichloro-2-benzothiazolyl)azo]phenyl]amino]- Certain Azo Disperse Dyes

Applying Significant New Activity provisions

View the Significant New Activity Publications under the Canadian Environmental Protection Act, 1999. For additional guidance on submitting information required as part of SNAc notifications, please see the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

In June 2008, requirements under the SNAc provisions of CEPA 1999 were applied to 145 PBiT substances. 

Final screening assessment

In April 2008, the Final Screening Assessment for the Screening Assessment of 145 PBiT Substances was published. The final screening assessment concludes that none of these 145 substances meet any of the criteria set out under section 64 of CEPA 1999. Therefore, it is recommended to take no further action on these substances at this time.

Environment Canada and Health Canada considered the new information received during the public comment period on the draft screening assessment and the notice of intent to apply the SNAc provisions of CEPA 1999 to 148 PBiT substances. As a result, 3 of the initial 148 PBiT substances are no longer considered eligible for the application of the SNAc provisions.

For 2 of these PBiT substances, CAS RN 13080-86-9 (BAPP - Batch 12) and 71032-95-6 (NDTHPM - Batch 9), evidence was provided indicating that they are presently in commerce in Canada. Therefore, these substances were added to and assessed under the Challenge Initiative.

A third substance, CAS RN 71832-83-2 (Pigment Red 48:5), has been found to no longer meet the categorization criteria for bioaccumulation and inherent toxicity. This substance was added to the Aromatic Azo and Benzidine-based Substance Grouping and was assessed under the Certain Monoazo Pigments Subgroup.

The draft screening assessment and the notice of intent to apply the SNAc provisions of CEPA 1999 to these substances were released on December 9, 2006, for a 60-day public comment period.

Background

The results of categorization indicated that there were 397 substances on the DSL that were PBiT to non-human organisms, according to the categorization criteria. Preliminary research indicated that a high percentage of these substances were no longer being manufactured in or imported into Canada. To establish whether this was the case, surveys were conducted on these substances in 2001 and 2006 by issuing notices pursuant to paragraphs 71(1)(a) and (b) of CEPA 1999 in the Canada Gazette, Part II.

Based on the survey results, there were no reports of industrial activity (import or manufacture) with respect to 148 of these PBiT substances in Canada, above the reporting threshold of 100 kg for the specified reporting years. These results suggested that the likelihood of exposure to these substances in Canada resulting from commercial activity at that time was low. In addition, no companies identified themselves as having an interest in any of the substances listed in the 2006 notice, providing further evidence that these substances were not of commercial interest in Canada.

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