ICCVAM Biennial Report 2014-2015

ICCVAM Biennial Report 2014-2015

Immunotoxicity Testing: CPSC Activities

Update of "Strong Sensitizer" Definition"

In 2014, the U.S. Consumer Product Safety Commission (CPSC) issued a final rule updating the Federal Hazardous Substances Act to clarify the definition of “strong sensitizer” as the term applies to substances and products that CPSC regulates. The revised definition eliminates redundancy, removes certain subjective factors, incorporates new and anticipated technology, defines criteria for “severity of reaction,” and provides for the use of a weight-of-evidence approach to determine whether a substance is a strong sensitizer. The new rule places the criteria for classification of strong sensitizers in the following descending order of importance: well-conducted clinical and diagnostic studies; epidemiological studies, with a preference for general population studies over occupational studies; well-conducted animal studies; well-conducted in vitro test studies; cross-reactivity data; and case histories. The new rule also provides for consideration of quantitative structure-activity relationships (QSAR), in silico data, specific human sensitization threshold values, and other data on potency and sensitizer bioavailability, if data are available and the methods validated.