Triclocarban - information sheet

Urea, N-(4-chlorophenyl)-N'-(3,4-dichlorophenyl)-
CAS Registry Number101-20-2

Publications summarized:

• Final Screening Assessment for Triclocarban (published on March 25, 2023). Public comments received on the draft screening assessment were considered and a summary was published.
• Associated notice: Canada Gazette, Part I: Vol. 157, No. 12 – March 25, 2023

On this page

• Overview
• About this substance
• Human and ecological exposures
• Key health and ecological effects (hazard)
• Consideration of vulnerable populations
• Risk assessment outcomes
  • Screening assessment conclusions
• Preventive actions and risk reduction
  • Where to find updates
• Related resources

Overview

• The Government of Canada conducts risk assessments of substances under the Canadian Environmental Protection Act, 1999 (CEPA 1999) to determine whether they present or may present a risk to human health or to the environment.
  • The risks posed by a substance are determined by both its hazardous properties (potential to cause adverse human health or ecological effects) and the amount or extent of exposure to people and the environment.
  • When needed, the Government implements risk management measures under CEPA 1999 and other federal acts to help prevent or reduce potential harm.
• The ecological hazard and exposure potentials of triclocarban were classified using the Ecological Risk Classification of Organic Substances (ERC) Approach.
• The Government concluded that triclocarban is not harmful to human health or to the environment at levels of exposure considered in the screening assessment. Triclocarban is associated with human health and ecological effects; however, current exposure levels are not of concern.

About this substance

• The screening assessment focused on urea, N-(4-chlorophenyl)-N'-(3,4-dichlorophenyl)-, also referred to as triclocarban. It was assessed under the third phase of the Chemicals Management Plan (CMP).
• According to information gathered by the Government, triclocarban is used in Canada in products available to consumers, including in a limited number of cosmetics such as bar soaps and facial cleansers.

Human and ecological exposures

• The screening assessment indicated that people in Canada may be exposed to triclocarban mainly through the use of cosmetics. Exposure may also occur from food and from the environment (drinking water, soil, and house dust).
• The screening assessment took into consideration the results of human biomonitoring studies. The information on measured levels in humans is important to estimate exposure to Canadians.
• According to the information considered under the ERC Approach, triclocarban was identified as having low ecological exposure potential.

Key health and ecological effects (hazard)

• The health effects characterization in the screening assessment considered data from international reports on triclocarban, among other sources of information. This included reviews by the European Commission's Scientific Committee on Consumer Products and the Australian Department of Health's National Industrial Chemicals Notification and Assessment Scheme.
• The critical effects identified for characterizing the risk to human health for triclocarban were effects on organs (spleen, kidney, liver, adrenal, heart, and pituitary).
• According to information considered under the ERC Approach, triclocarban was identified as having moderate ecological hazard potential based upon its potential effects on aquatic organisms. As this substance is known to possess antibacterial properties, its hazard classification was reviewed using a broader set of data than considered under the initial ERC analysis. Based on this additional analysis, triclocarban is considered to have a high hazard due to its inherent toxicity to aquatic organisms and its high potential for bioaccumulation in aquatic invertebrates.

Consideration of vulnerable populations

• There are groups of individuals within the Canadian population who, due to either greater susceptibility or greater exposure, may be more likely to experience adverse health effects from exposure to substances.
• Certain subpopulations are routinely considered throughout the screening assessment process, such as infants, children, and people of reproductive age. For instance, age-specific exposures are routinely estimated and developmental and reproductive toxicity studies are evaluated for potential adverse health effects. These subpopulations were taken into account in the risk assessment outcomes for triclocarban.
• In addition, Canadian human biomonitoring data were used in the triclocarban screening assessment to inform the consideration of these subpopulations.

Risk assessment outcomes

• The risk to human health from triclocarban is considered to be low. This was based upon a comparison of levels to which Canadians may be exposed to triclocarban, and levels associated with health effects.
• Based upon the outcome of the ERC Approach, triclocarban is considered unlikely to be causing ecological harm.

Screening assessment conclusions

• The Government concluded that triclocarban is not harmful to human health at levels of exposure considered in the assessment, and that triclocarban is not entering the environment at levels that are harmful.

Preventive actions and risk reduction

• Although triclocarban is not considered to be harmful to human health or to the environment at levels of exposure considered in the assessment, this substance is associated with ecological effects of concern. Changes in use patterns for triclocarban, such as using it as an alternative for chemicals with similar uses or functions, could lead to higher exposures.
• For this reason, the Government is considering follow-up activities to track changes in exposure or use patterns in Canada for triclocarban, which include:
  • Developing a monitoring plan for triclocarban in surface water and sediment by including it in the CMP Monitoring and Surveillance Program.
  • Publication of the Draft Federal Environmental Quality Guidelines (FEQGs) for triclocarban in water and sediment for a 60-day public comment period ending on May 24, 2023.
  • Continuing to monitor products available to consumers containing triclocarban through the Food and Drugs Actand the Pest Control Products Act:
    • Notification of ingredients in cosmetics is required under the Cosmetic Regulations under the Food and Drugs Act. Under section 30 of the Cosmetic Regulations, manufacturers and importers must notify Health Canada within 10days after they sell a cosmetic in Canada.
    • Use of triclocarban in drugs and natural health products requires pre-market approval under the Food and Drugs Act.
    • Use of the substance as a food additive, incidental additive, or component used to manufacture food packaging materials also requires notification under the Food and Drugs Act.
    • Use of the substance in pest control products requires assessment and registration under the Pest Control Products Act.
  • Nominating triclocarban to the Identification of Risk Assessment Priorities process on a recurring basis, to determine whether further action is required.
  • Considering inclusion of triclocarban on the "watch list" currently being proposed under amendments to CEPA 1999 (Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act).

Where to find updates

• Updates on actions can be found on the timeline for triclocarban. Information on the FEQGs and on environmental monitoring (water quality and sediment) is also available and updated periodically.
• Use the Substances Search tool to find substances that are referenced in certain legislative or regulatory instruments or on Government of Canada websites.

Related resources

• Triclocarban may be found in products available to consumers. People in Canada should follow any safety warnings and directions related to the product and dispose of products responsibly according to municipal or local guidelines.
• The screening assessment focused on potential risks from exposure of the general population of Canada. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS). For information concerning workplace health and safety and what steps to take in the workplace, Canadians should consult their employer or the Occupational Health and Safety Regulator in their jurisdiction.