Final Assessment Report Triclosan

Chemical Abstracts Service Registry Number
3380-34-5

Environment and Climate Change Canada
Health Canada

November 2016

(PDF Version - 2 175 KB)

Table of Contents

• Synopsis
• 1. Introduction
• 2. Substance Identity, Properties and Uses
  • 2.1 Substance Identity
    • 2.1.1 Impurities of human health and environmental concern
  • 2.2 Physical and Chemical Properties
  • 2.3 Triclosan Use Patterns in Canada
    • 2.3.1 Cosmetic products
    • 2.3.2 Natural health products
    • 2.3.3 Drug products
    • 2.3.4 Pest control products
    • 2.3.5 Mandatory survey
• 3. Human Health
  • 3.1 Toxicology Profile of Triclosan
    • 3.1.1 Metabolism and toxicokinetics
    • 3.1.2 Acute toxicity
    • 3.1.3 Subchronic toxicity
    • 3.1.4 Reproductive toxicity
    • 3.1.5 Developmental toxicity
    • 3.1.6 Chronic toxicity
    • 3.1.7 Genotoxicity
    • 3.1.8 Carcinogenicity potential in humans
    • 3.1.9 Neurotoxicity
    • 3.1.10 Thyroid effects
    • 3.1.11 Immunotoxicity
  • 3.2 Toxicological Endpoints for the Human Health Risk Assessment
    • 3.2.1 Completeness of the database
    • 3.2.2 PCPA hazard characterization
    • 3.2.3 Acceptable daily intake (all populations)
    • 3.2.4 Toxicological endpoints for residential and occupational risk assessment
    • 3.2.5 Aggregate exposure scenarios
    • 3.2.6 Cancer risk assessment
  • 3.3 Human Health Exposure and Risk
    • 3.3.1 General population exposure and risk assessment
    • 3.3.2 Estimation of the daily exposure dose based on the urinary triclosan concentration
    • 3.3.3 Aggregate risk assessment for the general population (3-79 years of age)
    • 3.3.4 Aggregate risk assessment for children younger than 3 years of age
    • 3.3.5 Human health risk assessment for workers exposed to pest control products containing triclosan
  • 3.4 Cumulative Effects
  • 3.5 Transformation Products
  • 3.6 Antimicrobial Resistance
• 4. Environment
  • 4.1 Releases and Presence of Triclosan in the Environment
    • 4.1.1 Releases to water
    • 4.1.2 Releases to soil
    • 4.1.3 Environmental concentrations
  • 4.2 Environmental Fate
    • 4.2.1 Environmental distribution
    • 4.2.2 Fate in air
    • 4.2.3 Fate in water
    • 4.2.4 Fate in sediment
    • 4.2.5 Fate in soil
    • 4.2.6 Relevance of environmental fate of triclosan
  • 4.3 Bioaccumulation
    • 4.3.1 Aquatic organisms
    • 4.3.2 Bioaccumulation in terrestrial organisms
    • 4.3.3 Relevance of triclosan bioaccumulation
  • 4.4 Ecological Effects
    • 4.4.1 Mode of action
    • 4.4.2 Ecotoxicity
    • 4.4.3 Relevance of the effects data for triclosan
  • 4.5 Ecological Exposure and Risk Assessment
    • 4.5.1 Water
    • 4.5.2 Sediment
    • 4.5.3 Soil
    • 4.5.4 Characterization of ecological risk
  • 4.6 Consideration of the Lines of Evidence and Uncertainties
  • 4.7 Conclusion of Risk to the Environment
• 5. Conclusion
  • 5.1 Conclusions under CEPA 1999
  • 5.2 Conclusions under PCPA
• References
• List of Abbreviations
• Appendicies
  • Appendix A. Toxicological Endpoints for Triclosan Health Risk Assessments
  • Appendix B. Unadjusted, Specific Gravity and Creatinine Adjusted Urinary Triclosan Concentrations per Unit Body Weight (ug/L/kg)
  • Appendix C. Unadjusted, Specific Gravity and Creatinine Adjusted Urinary Triclosan Concentrations
  • Appendix D. Estimated Daily Doses
  • Appendix E. Unadjusted, Specific Gravity and Creatinine Adjusted Urinary Triclosan Concentrations

Tables and Figures

• Table 2-1. Substance identity for triclosan
• Table 2-2. Physical and chemical properties of triclosan
• Figure 3-1. Proposed adverse outcome pathway for the effects of triclosan on the thyroid hormone system [TR = thyroid receptor]
• Table 3-1. Summary of triclosan excretion data in humans
• Table 3-2. General population risk based daily dose estimates derived from geometric mean and 95th percentile specific gravity adjusted urinary concentrations and a range of typical urine volumes
• Table 3-3. Unadjusted concentrations of total triclosan in urine of children less than 6 years of age
• Table 3-4. Concentration of total triclosan in human breast milk
• Table 3-5. Exposure of infants to triclosan in breast milk
• Table 3-6. Incidental oral exposure of a 6- to 12-month-old infant mouthing a toy made from plastic treated with triclosan
• Table 3-7. Triclosan in household dust
• Table 3-8. Aggregate risk estimates for children less than 3 years of age
• Table 3-9. Occupational risk assessment for industrial handler
• Figure 4-1. Possible pathways for releases of triclosan to the environment (modified from Bound and Voulvoulis 2005)
• Table 4-1. Concentration of triclosan in the influent and effluent of certain WWTPs in Canada
• Table 4-2. Concentrations of triclosan in wastewater sludge or biosolids in Canada (digested sludge unless specified otherwise)
• Table 4-3. Concentrations of triclosan in surface water in Canada
• Table 4-4. Sediment monitoring data for triclosan and methyl-triclosan in Canada in 2012-2013a
• Table 4-5. Distribution of the two forms of triclosan among environmental compartments at pH 7 and 8
• Table 4-6. Data on the persistence of triclosan in different media
• Table 4-7. Comparison of the properties of triclosan with the leaching criteria of Cohen et al. (1984)
• Table 4-8. Leachability classification system based on calculated GUS indices
• Table 4-9. Measured concentrations of triclosan in tissues of aquatic organisms
• Figure 4-2. Prediction of potential metabolites from triclosan using the BCFMax Model with Mitigating Factors (Dimitrov et al. 2005)
• Table 4-10. Summary of bioconcentration (BCF) and bioaccumulation (BAF) data in aquatic species
• Table 4-11. Experimental data on the presence or bioaccumulation of methyl-triclosan in aquatic organisms
• Table 4-12. Chronic toxicity of triclosan to freshwater aquatic organisms
• Figure 4-3. Species sensitivity distribution (SSD) for triclosan based on selected chronic toxicity data for freshwater aquatic organisms (Table 4-12). The normal model fit to the data is shown on the graph along with the 95% confidence intervals
• Table 4-13. Toxicity of triclosan to terrestrial organisms
• Table 4-14. Uncertainty characterization and analysis of the weight of evidence in the risk assessment of triclosan