Abstract
A focal point in the safety evaluation of cosmetic ingredients includes oral repeated dose toxicity testing, which is intended to address the most complex human endpoints. Seven years after the full implementation of the animal testing ban for cosmetic ingredients in the EU, there are still no alternative methods available capable of fully replacing oral repeated dose toxicity testing. Until this issue is resolved, the development of new cosmetic ingredients remains seriously hampered. The present paper describes a thorough screening of the oral repeated dose toxicity data included in safety evaluation reports of cosmetic ingredients addressed in the Annexes of the Cosmetics Regulation (EC) No 1223/2009, issued by the Scientific Committee on Consumer Safety between 2009 and 2019. The liver and the haematological system were identified as the potentially most frequently affected organs upon oral administration of cosmetic ingredients to animals. Evaluation of altered biochemical, morphological, and histopathological parameters related to hepatotoxicity indicated that the most recurrent events are liver weight changes, elevated liver enzymes, and alterations in serum cholesterol and bilirubin levels. Combined listing of affected parameters associated with steatosis and cholestasis indicated the possible occurrence of cholestasis, provoked by a limited number of cosmetic ingredients. The most frequently affected parameters related to the haematological system were indicative of anaemia. An in-depth analysis allowed characterisation of both regenerative and non-regenerative anaemia, pointing to direct and indirect haematotoxicity, respectively. The results presented in this study call for prioritisation of research targeted towards the development of new approach methodologies fit for animal-free repeated dose toxicity evaluation of cosmetic ingredients.
Highlights
The procedure for safety evaluation of cosmetic products and their ingredients has undergone major changes in Europe during the past decade
Among the 101 substances covered in the Scientific Committee on Consumer Safety (SCCS) opinions included in the study, no adequate oral repeated dose toxicity (RDT) data for determination of an no observed adverse effect level (NOAEL) were available for 13 cosmetic ingredients
A total of 37 28-day oral toxicity studies were available for 26 cosmetic ingredients, indicating that a particular chemical compound may have been subjected to a similar test more than once
Summary
The procedure for safety evaluation of cosmetic products and their ingredients has undergone major changes in Europe during the past decade. A marketing ban (i.e., the marketing in the EU of cosmetic products and their ingredients tested on animals to evaluate their safety) was introduced for all human health effects. The ban was taken up in Cosmetics Regulation (EC) No 1223/2009 (EU 2009), despite the fact that non-animal methods capable of assessing those particular toxicological endpoints were lacking. Today, validated non-animal methods are available for testing short-term and local toxicological endpoints, including skin irritation/corrosion (1OECD 439, 431, 435, 430) and eye damage/irritation (OECD 491, 492, 437, 438). 7 years after the full implementation of the animal testing ban for cosmetic ingredients, non-animal methods for testing RDT [i.e., subacute (28 days), sub-chronic (90 days), and chronic (85% of expected lifetime) studies], are still lacking
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