Exposure based waiving: The application of the toxicological threshold of concern (TTC) to inhalation exposure for aerosol ingredients in consumer products

Abstract

The inhalation toxicology studies available in the public domain have been reviewed to establish a database for inhalation toxicology and derive thresholds of toxicological concern (TTC) for effects in the respiratory tract and systemically for Cramer class 1 and 3 chemicals. These TTCs can be used as the basis for developing an exposure based waiving (EBW) approach to evaluating the potential for adverse effects from exposure to ingredients in aerosol products, used by consumers. The measurement of consumer exposure in simulated product use is key to the application of an exposure based waiving approach to evaluating potential consumer risk. The detailed exposure evaluation for aerosol ingredients with defined use scenarios, in conjunction with an evaluation of the potential structure activity relationship for toxicity and the TTCs for inhalation exposure could be used to waive undertaking inhalation toxicology studies under REACH. Not all classes of chemicals are suitable for such an approach, but for chemicals with a predictable low potential toxicity, and very low levels of exposure, this approach, could reduce the amount of inhalation toxicology studies required for the implementation of the European REACH legislation. Such an approach is consistent with the concept of developing ‘intelligent testing strategies’ for REACH.