Use of Skin Absorption Data in the Safety Evaluation of Cosmetic Ingredients

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.

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8 Final Report on the Safety Assessment of Sodium Cetearyl Sulfate

Journal of the American College of Toxicology ◽

10.3109/10915819209141995 ◽

1992 ◽

Vol 11 (1) ◽

pp. 145-155 ◽

Cited By ~ 1

Keyword(s):

Test Data ◽

Safety Assessment ◽

Sodium Lauryl Sulfate ◽

Safety Evaluation ◽

Final Report ◽

Lauryl Sulfate ◽

Chemical Similarity ◽

Ocular Irritation ◽

Safety Test ◽

Cosmetic Ingredients

Sodium Cetearyl Sulfate is the sodium salt of a mixture of cetyl and stearyl sulfate which is used as a surfactant and cleansing agent in cosmetics at concentrations ranging from ≥ 0.1 to 25.0%. The LD50 was not achieved in two studies in which rats received a single oral dose of 5.0 ml/kg. In ocular irritation tests, 20.0% aqueous Sodium Cetearyl Sulfate was not irritating to the eyes of rabbits. Twenty percent Sodium Cetearyl Sulfate was not irritating to the skin of rabbits. In a guinea pig sensitization study, Sodium Cetearyl Sulfate was not a sensitizer. Sodium Cetearyl Sulfate is less irritating to the skin than Sodium Lauryl Sulfate, whose safety test data are summarized in the report. Due to the chemical similarity of these two cosmetic ingredients, the safety test data on Sodium Lauryl Sulfate was considered to be applicable to the safety evaluation of this ingredient. On the basis of the animal and clinical data on Sodium Cetearyl Sulfate and Sodium Lauryl Sulfate as presented in the report, it is concluded that Sodium Cetearyl Sulfate is safe as a cosmetic ingredient in the present practices of use and concentration.

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