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Publication of Results of Investigations and Recommendations for a Substance - 3,5-Dimethylaniline (Subsections 68(b) and (c) of the Canadian Environmental Protection Act, 1999) Whereas a summary of a follow-up report to the assessment of 3,5-dimethylaniline, a substance previously specified on the Priority Substances List, is annexed hereby, 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 3,5-dimethylaniline be added to the List of Toxic Substances in Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA 1999). Notice furthermore is hereby given that consultations will be held on the development of a regulation or instrument respecting preventive or control action in relation to 3,5-dimethylaniline. Public Comment Period Any person may, within 60 days of publication of this notice, file with the Minister of the Environment comments with respect to this proposal. All comments must cite the Canada Gazette, Part 1, and the date of publication of this notice, and be sent to the Director, Existing Substances Branch, Department of the Environment, Hull, Quebec K1A 0H3, (819) 953-4936 (Facsimile) or by electronic mail to PSL.LSIP@ec.gc.ca. If appropriate, the comments should stipulate those parts thereof that should not be disclosed pursuant to the Access to Information Act and, in particular, pursuant to sections 19 and 20 of that Act, the reason why those parts should not be disclosed and the period during which they should remain undisclosed. JOHN ARSENEAU Director General Toxic Pollution Prevention Directorate On behalf of the Minister of the Environment ROD RAPHAEL Director General Safe Environments Programme On behalf of the Minister of Health Annex Summary of the Follow-up Report to the Assessment of the Substance 3,5-Dimethylaniline 3,5-Dimethylaniline is used principally as an intermediate in the manufacture of azo dyes and was not believed to be produced or imported into Canada, until it was recently notified in a Schedule 1 submission under the New Substances provisions of CEPA 1999. Information on the presence of this substance in products imported into Canada has not been identified. 3,5-Dimethylaniline was included on the first Priority Substances List (PSL1) under the 1988 Canadian Environmental Protection Act (CEPA 1988) for assessment of potential risks to the environment and human health. It is also included on the Non-Domestic Substances List (NDSL). Importation and manufacture are limited, therefore, by section 81 of CEPA 1999 and the New Substances Notification Regulations to 1 000 kg/year per potential notifier. As outlined in the Assessment Report released in 1993, relevant data identified before October 1992 were considered insufficient to conclude whether 3,5-dimethylaniline was "toxic" to human health as defined in paragraph 11(c) under CEPA 1988. Neither additional monitoring data nor adequate studies in experimental species or humans relevant to assessment of the human health risks for the likely critical endpoint for 3,5-dimethylaniline were identified during the period following the release of the PSL1 Assessment Report (prior to December 2000). However, predictions from quantitative structure-activity relationship (QSAR) modelling indicate with a moderate to high degree of confidence that 3,5-dimethylaniline is likely to be carcinogenic and mutagenic in experimental models. Therefore, it is concluded that there is reason to suspect that 3,5-dimethylaniline is "toxic" to human health. Information necessary to permit a more definitive conclusion under CEPA includes studies in experimental species to address repeated dose toxicity and carcinogenicity. Following the publication of this notice, any companies using 3,5-dimethylaniline are invited to identify themselves and provide relevant data to permit additional assessment and a more definitive conclusion of "toxic" or not considered to be "toxic." If no relevant information is received, it is proposed that the Ministers of the Environment and of Health consider the compound "toxic" as defined in paragraph 64(c) of the Canadian Environmental Protection Act, 1999. The full Follow-up Report may be obtained from the Green Lane Web site (http://www.ec.gc.ca/substances/ese/eng/PSAP/ PSL1_IIC.cfm) or from the Inquiry Centre, Environment Canada, Hull, Quebec K1A 0H3 (1-800-668-6767). [40-1-o]
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