The Government of Canada conducted a science-based evaluation, called a screening assessment, to address the potential for harm to Canadians and to the environment from triclocarban.
Under the Canadian Environmental Protection Act, 1999, the risk posed by a substance is determined by considering both its hazardous properties (its potential to cause adverse human health or ecological effects) and the amount of exposure there is to people and the environment. A substance may have hazardous properties; however, the risk to human health or to the environment may be low depending upon the level of exposure.
As a result of the draft screening assessment, the Government is proposing that triclocarban is not harmful to human health or to the environment at levels of exposure considered in the assessment.
About this substance
The screening assessment focuses on the substance urea, N-(4-chlorophenyl)-N'-(3,4-dichlorophenyl)-, also referred to as triclocarban. It was assessed under the Chemicals Management Plan (CMP).
According to information gathered by the Government, in Canada, triclocarban is used as an antibacterial ingredient in cosmetic and drug products.
Human and ecological exposures
Canadians may be exposed to triclocarban through the use of products available to consumers, such as bar soaps and facial cleansers.
The 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 information considered under the ERC Approach, triclocarban was identified as having low ecological exposure potential.
Key health and ecological effects (hazard)
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 a known anti-bacterial agent, 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 and gastropods (such as clams and mussels).
Risk assessment outcomes
The risk to human health from triclocarban is considered to be low, based upon a comparison of levels to which Canadians may be exposed to triclocarban, and the levels associated with health effects.
Triclocarban is considered unlikely to be causing ecological harm at levels of exposure considered in the assessment, based upon the outcome of the ERC Approach.
As a result of the draft screening assessment, the Government is proposing that triclocarban is not harmful to human health at levels of exposure considered in the assessment, and that it is not entering the environment at levels that are harmful to the environment.
Preventive actions and reducing risk
Although triclocarban is not considered to be harmful 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 a higher risk of exposure.
For this reason, follow-up activities to track changes in exposure or use patterns for triclocarban are being considered including significant new activity orders, information gathering under section 46 or 71 of CEPA, and biomonitoring and/or environmental monitoring.
Stakeholders are encouraged to provide any information pertaining to this substance that may help inform the choice of follow-up activity, during the 60-day public comment period on the assessment. This could include information on new or planned import, manufacture or use of the substance.
Triclocarban may be found in products available to consumers. Canadians should follow any safety warnings and directions related to the product and dispose of products responsibly.