3,5-Dimethylaniline (3,5-DMA)

Listed on the First Priority Substances List (PSL1). Follow-up Assessment concludes that 3,5-DMA is subject to the New Substances Notification Regulations

3,5-Dimethylaniline is one of the 44 substances placed on the First Priority Substances List (PSL1) to determine whether the substance posed a significant risk to the health of Canadians or to the environment.

Assessment Status and Conclusion

The final PSL1 assessment report was published in 1993 and there was insufficient information to determine whether the substance constitutes a danger in Canada to human life or health.

Health Canada has reviewed new and existing information for 3,5-DMA and has released a draft follow-up report in October 2002. No comments were received during the 60-day comment period following the release of the draft follow-up report.

The final follow-up report concludes that an evaluation of the exposure potential as well as the potential effects on human health and the environment will be performed prior to the importation or manufacture of the substance when additional notification under the New Substances Notification Regulations is submitted.

Related Information

• Synopsis of the Follow-up Report (2004)
  
• A notice has been published in Canada Gazette Part I on February 19th , 2005 - Publication of Final Results of Investigations and Recommendations for a Substance -- bis(2-chloroethyl) ether (subsections 68 (b) and (c) of the Canadian Environmental Protection Act, 1999).

Publications

• PSL1 Assessment Report (1993)
  
  To obtain a paper copy of the PSL1 assessment report, please contact the Inquiry Centre at Environment Canada, at:
  
  Inquiry Centre
  70 Crémazie, 7th Floor
  Gatineau, Quebec K1A OH3
  Phone: 1-800-668-6767
  
• Follow-up Report on a PSL1 Substance for Which Data Were Insufficient to Conclude Whether the Substance Was "Toxic" to Human Health. 3,5-Dimethylaniline. Government of Canada, Health Canada. 2004
  
  To obtain an electronic copy of the follow-up report, please send an email to existing.substances.existantes@ec.gc.ca, or visit Health Canada's website at http://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1-lsp1/index_e.html.

Synopsis of Follow-up Report (2004)

3,5-Dimethylaniline has historically been used principally as an intermediate in the manufacture of azo dyes.

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. 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 and 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 animals. Information on the presence of this substance in formulations imported into Canada has not been identified.

3,5-Dimethylaniline is not included on the Domestic Substances List; its importation and manufacture are therefore subject to Section 81 of the Canadian Environmental Protection Act, 1999 (CEPA 1999) and the New Substances Notification Regulations.

3,5-Dimethylaniline was not believed to be produced in or imported into Canada until it was recently notified under the New Substances provisions of CEPA 1999. The information was evaluated in the context of two Schedule 1 notifications. The use proposed is as a reaction intermediate where releases are not anticipated. The structural concerns remain but will be considered further at the next level of notification. Owing to low exposure potential, risk is low.

An evaluation of the exposure potential as well as the potential effects on human health and the environment will be performed prior to the importation or manufacture of the substance when additional notification under the New Substances Notification Regulations is submitted. Should a suspicion of toxic to human health or the environment be identified at that time, appropriate control measures under CEPA 1999 will be introduced.

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