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Preliminary Risk Assessment for the Pesticide Uses of Triclosan
Current as of June 2008
The preliminary human health and environmental risk assessments for the pesticide uses of triclosan have been released by the Agency for a Phase 3 60-day public comment period. The public comment period is intended to provide an opportunity for interested stakeholders to provide comments on the assessments and use and usage information and input on possible mitigation measures. The assessments and related documents are available at http://www.regulations.gov in docket number EPA-HQ-OPP-2007-0513.
Sources of triclosan
Use profile for triclosan when used as an antimicrobial pesticide
Triclosan is regulated by both the U.S. EPA and the U.S. Food and Drug Administration (FDA). The EPA regulates the antimicrobial uses of triclosan when used as a bacteriostat, fungistat, mildewistat, and deodorizer. The FDA-registered uses include hand soaps, toothpaste, deodorants, laundry detergent, fabric softeners, facial tissues, antiseptics for wound care, and medical devices. Although these uses are not regulated under pesticide law, these exposures have been considered in EPA’s aggregate risk assessment. Population-based biological monitoring data were used to assess the co-occurrence of uses to develop an aggregate exposure assessment.
Triclosan (2,4,4’ –trichloro-2’-hydroxydiphenyl ether) is a chlorinated aromatic compound that has functional groups representative of both phenols and ethers and is used as a synthetic broad-spectrum antimicrobial agent. Triclosan was first registered by EPA in 1969. Currently there are 20 antimicrobial registrations. Triclosan is used in commercial, institutional, and industrial premises and equipment; residential and public access premises; and as a materials preservative.
Commercial, institutional, and industrial premises and equipment uses include conveyor belts, fire hoses, dye bath vats, and ice-making equipment. As a material preservative, triclosan is used in many products including adhesives, fabrics, vinyl, plastics (toys, toothbrushes), polyethylene, polyurethane, polypropylene, floor wax emulsions, textiles (footwear, clothing), caulking compounds, sealants, rubber, and latex paints. There is a multitude of residential and public access premises uses including direct application to HVAC coils (commercial use only) and use as a materials preservative in carpet shampoos, toys, paints, mattresses, clothing, brooms, mulch, floors, shower curtains, awnings, tents, toilet bowls, urinals, garbage cans, refuse container liners, insulation, concrete mixtures, grouts, and upholstery fabrics.
Summary of the findings of preliminary risk assessment
The use of triclosan as a registered pesticide represents a small portion of the overall use of this chemical.
Human Health
Based on the registered use patterns, the triclosan risk assessment evaluated dermal and inhalation exposures that result from applications in residential and occupational settings. EPA assessed post-application dermal exposure to triclosan for adults wearing treated clothing. In addition, EPA evaluated incidental oral exposure for toddlers mouthing treated textiles and plastic toys. EPA conducted these assessments using available animal studies.
EPA conducted an aggregate assessment to evaluate the potential for co-occurrence of uses, including the uses that are registered by the FDA (hand soaps, toothpaste, deodorants, laundry detergent, fabric softeners, facial tissues, antiseptics for wound care, and medical devices). These exposures were considered in the aggregate risk assessment using National Health and Nutrition Surveys (NHANES) biological monitoring monitoring data to assess the co-occurrence of uses. The NHANES data are believed to be a more accurate predictor of aggregate exposure not only because the data are triclosan-specific, but they are also based on actual consumer use of the various triclosan products as they co-occur through normal use.
Residential risks are not of concern for all scenarios. Occupational risks are not of concern except for commercial painters and applications to pulp and paper as a materials preservative.
However, because there are many uses of triclosan under the regulation of the FDA, for the aggregate assessment the Agency used the most protective assumptions from the NHANES data. This assessment indicates that there are no concerns for uses that are anticipated to co-occur.
Environmental Fate and Ecological Risks
Based on available data, triclosan is expected to be immobile in soil and is not expected to volatilize from soil (moist or dry) or water surfaces. In aquatic environments, triclosan is expected to adsorb to (attach to the surface of) suspended solids and sediments and may bioaccumulate, potentially posing a concern for aquatic organisms. There is also a low-to-moderate potential for bioconcentration in aquatic organisms. The majority of published studies on the occurrence of triclosan in waste water treatment plants, treatment plant efficiency, and open water measurements of triclosan suggest that aerobic biodegradation is one of the major and most efficient biodegradation pathways.
Based on monitoring data, triclosan was found in approximately 36 U.S. streams (Klopin et al., 2002) where effluent from activated sludge waste water treatment plants, trickle-down filtration, and sewage overflow are thought to contribute to the occurrence of triclosan in open water.
Next Steps
Related Information
An ecological risk assessment is not typically conducted for the antimicrobial uses registered for triclosan. However, since triclosan has been detected in natural waters, EPA has performed a qualitative environmental risk assessment using monitoring levels of triclosan found in waterways. Risk quotients (RQs) were developed using toxicity data then compared to levels of concern (LOCs) for triclosan. LOCs were not exceeded for aquatic organisms. However, there was a slight risk to aquatic plants. There were no acceptable acute toxicity studies for freshwater invertebrates or estuarine and marine organisms nor were there any acceptable chronic toxicity studies available for aquatic organisms. The Agency needs additional data to evaluate the risks to these species.The Reregistration Eligibility Decision (RED) is scheduled for completion in September 2008.EPA’s public docket: www.regulations.gov EPA-HQ-OPP-2007-0513
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