Abstract
Since the animal test ban on cosmetics in the EU in 2013, alternative in vitro safety tests have been actively researched to replace in vivo animal tests. For the development and evaluation of a new test method, reference chemicals with quality in vivo data are essential to assess the predictive capacity and applicability domain. Here, we compiled a reference chemical database (ChemSkin DB) for the development and evaluation of new in vitro skin irritation tests. The first candidates were selected from 317 chemicals (source data n = 1567) searched from the literature from the last 20 years, including previous validation study reports, ECETOC, and published papers. Chemicals showing inconsistent classification or those that were commercially unavailable, difficult or dangerous to handle, prohibitively expensive, or without quality in vivo or in vitro data were removed, leaving a total of 100 chemicals. Supporting references, in vivo Draize scores, UN GHS/EU CLP classifications and commercial sources were compiled. Test results produced by the approved methods of OECD Test No. 439 were included and compared using the classification table, scatter plot, and Pearson correlation analysis to identify the false predictions and differences between in vitro skin irritation tests. These results may provide an insight into the future development of new in vitro skin irritation tests.
Highlights
IntroductionMost of the toxicity items required for the safety evaluation of chemicals use experimental animals, but more than 35 countries have banned animal tests for cosmetics since 2013 [2,3]
To establish the ChemSkin DB, the reference chemicals were searched from the literature over the last 20 years and reviewed for the quality of in vivo data and availability of in vivo scores, which is critical for the classification of optional Category 3 as recently stated by UN GHS
Detailed information such as supporting literature, in vivo Draize scores, UN GHS/EU CLP classifications, and commercial sources were included, which could be invaluable for the developers of new skin irritation test methods
Summary
Most of the toxicity items required for the safety evaluation of chemicals use experimental animals, but more than 35 countries have banned animal tests for cosmetics since 2013 [2,3]. For the regulatory body to accept the data produced from methods other than the standard test method, the methods should be verified in their ability to address the toxic endpoint with relevance and reliability to the same extent as the existing standard test method through officially endorsed procedures. This validation procedure is clearly described in OECD
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