Evaluating the applicability of the Ames test for cosmetic packaging assessment by comparing carcinogenic risk levels of migrants from plastics with biological detection limits

Risk assessments for cosmetic packaging are required according to the EU Cosmetics Regulation (EC) No. 1223/ 2009, however, the assessment method is well-established for food packaging but limited for cosmetic packaging. In food packaging assessments, Cramer class III TTC (90 mu g/day) is applied as the threshold for systemic toxicity when the Ames test including the process of sample concentration steps provides the negative results. However, the human health risks of mutagenic and carcinogenic migrants at exposure levels where the Ames test with the concentrated samples cannot detect are unclear.In the present study, to confirm the applicability of the Ames test for cosmetic packaging assessments, the toxicological data on 37 candidate migrants with Ames test-positive results was collected. For these migrants, the carcinogenic risk levels through cosmetics use were compared to the detection levels of the Ames test for concentrated samples. Regarding at least 32 migrants, the case study showed the negative result from the Ames test incorporating the sample concentration process would indicate negligible mutagenic and carcinogenic risks of packaging extracts. Therefore, application of the Ames test to cosmetic packaging assessments would be helpful to ensure the safety for mutagenicity and carcinogenicity as well as use Cramer-TTC for systemic toxicity.