Priority Substances List Assessment Report for N-Nitrosodimethylamine (NDMA)

Environment Canada
Health Canada
2001
ISBN: 0-662-29137-9
Cat. No.: En40-215/53E

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(487K)

Canadian Environmental Protection Act, 1999

Table of Contents

• List of Acronyms and Abbreviations
• Synopsis
• 1.0 Introduction
• 2.0 Summary of Information Critical to Assessment of "Toxic" Under CEPA 1999
  • 2.1 Identity and physical/chemical properties
    • 2.1.1 Analytical methods
  • 2.2 Entry characterization
    • 2.2.1 Production, uses and importation
    • 2.2.2 Sources and releases
      • 2.2.2.1 Natural sources
      • 2.2.2.2 Anthropogenic sources
  • 2.3 Exposure characterization
    • 2.3.1 Environmental fate
      • 2.3.1.1 Air
      • 2.3.1.2 Water
      • 2.3.1.3 Sediment
      • 2.3.1.4 Soil
      • 2.3.1.5 Biota
      • 2.3.1.6 Environmental partitioning
    • 2.3.2 Environmental concentrations
      • 2.3.2.1 Ambient Air
      • 2.3.2.2 Indoor air
      • 2.3.2.3 Water
      • 2.3.2.4 Sediment and soil
      • 2.3.2.5 Human tissues
      • 2.3.2.6 Food
      • 2.3.2.7 Consumer products
  • 2.4 Effects characterization
    • 2.4.1 Ecotoxicology
      • 2.4.1.1 Aquatic organisms
    • 2.4.2 Abiotic atmospheric effects
    • 2.4.3 Experimental animals and in vitro
      • 2.4.3.1 Acute toxicity
      • 2.4.3.2 Short-term and subchronic toxicity
      • 2.4.3.3 Carcinogenicity
      • 2.4.3.4 Genotoxicity
      • 2.4.3.5 Reproductive and developmental toxicity
      • 2.4.3.6 Neurotoxicity and effects on the immune system
      • 2.4.3.7 Toxicokinetics and mode of action
    • 2.4.4 Humans
• 3.0 Assessment of "Toxic" under CEPA 1999
  • 3.1 CEPA 1999 64(a): Environment
    • 3.1.1 Assessment endpoints
      • 3.1.1.1 Assessment endpoints for releases to water
    • 3.1.2 Environmental risk characterization
      • 3.1.2.1 Aquatic organisms
      • 3.1.2.2 Discussion of uncertainty
  • 3.2 CEPA 1999 64(b): Environment upon which life depends
  • 3.3 CEPA 1999 64(c): Human health
    • 3.3.1 Estimated population exposure
    • 3.3.2 Hazard characterization
      • 3.3.2.1 Carcinogenicity
      • 3.3.2.2 Non-neoplastic effects
    • 3.3.3 Exposure-response analyses
      • 3.3.3.1 Carcinogenicity
      • 3.3.3.2 Non-neoplastic effects
    • 3.3.4 Human health risk characterization
    • 3.3.5 Uncertainties and degree of confidence in human health risk characterization
  • 3.4 Conclusions
  • 3.5 Considerations for follow-up (further action)
• 4.0 References
• Appendix A Search Strategies Employed for Identification of Relevant Data

List of Tables

• Table 1 Physical and chemical properties of NDMA
• Table 2 Carcinogenicity study with male rats
• Table 3 Carcinogenicity study with female rats
• Table 4 Reasonable worst-case estimates of daily intake of NDMA by the general population in Canada
• Table 5 Data on hepatic carcinogenicity in male rats used for modelling
• Table 6 Data on hepatic carcinogenicity in female rats used for modelling
• Table 7 TD₀₅s for NDMA

List of Figures

• Figure 1 Chemical structure of NDMA
• Figure 2 TD₀₅s for NDMA