Abstract
During the development of cosmetic formulations, in vitro and in vivo methods are essential tools used to reliably assess the skin irritation potential of a product or ingredient. Epicutaneous patch testing (single and/or multiple application protocols) has long been used as an initial in vivo method to screen for possible skin irritation properties of a substance or formulation. To confirm the mildness and dermatological and/or consumer acceptance of a product, use tests are often subsequently conducted. A study was therefore initiated to see how well patch test results correlate with use tests with respect to irritation elicited by skincare (leave-on) products. A number of different cosmetic formulations were assessed in both tests. Although the patch test results did not indicate substantial irritation potentials, immediate-type reactions (stinging and redness) were observed in some volunteers which disappeared within approx. 1h. Although transient, these reactions suggested that consumer acceptance would probably be low and the studies were discontinued. Immediate-type reactions are rare but have been described for some substances used in cosmetics. These unexpected results were nevertheless intriguing and prompted the start of a journey to see if patch test protocols could be modified to assess these reactions. An occlusive short-term patch test protocol with an application period of 20min was developed. Successful identification of the spontaneous reactions became possible. Furthermore, there was a correlation between the intensity of reactions observed in the short-term patch test and those observed in the controlled in-use studies. Short-term patch testing using the developed protocol can therefore reliably be used as a screening method, for example in the development and optimization of cosmetic formulations containing ingredients that could cause spontaneous reactions, for instance of non-immunological contact urticaria type. The lessons learned from this studies indicate that simple modifications of existing test protocols can lead to important insights into skin reactions. These modifications can then be used to create further building blocks in the development and optimization of test strategies for cosmetic formulations which offer reliable study designs for possible reactions product developers may encounter.
Highlights
What is a cosmetic? According to EU Cosmetic Regulation (EC) N° 1223/2009 on cosmetic products, a ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours [1]
Epicutaneous patch testing for irritation (ECT; single and/or multiple application protocols) has long been used as an initial in vivo method to screen for possible skin irritation properties of a substance or formulation [2,3]
The epicutaneous patch testing is routinely used as a screening method in the development and optimization of cosmetic formulations, it does not allow all reactions to be assessed and surprises can be encountered
Summary
What is a cosmetic? According to EU Cosmetic Regulation (EC) N° 1223/2009 on cosmetic products, a ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours [1]. Regulation (EC) N° 1223/2009 mandates that cosmetic products put on the market should not be harmful to human health with Annex 1 §8 specifying that a particular focus should lie on local toxicity which includes skin irritation. During the development of cosmetic formulations, in vivo human test methods are indispensable tools used to assess the skin irritation potential of a product or ingredient. Epicutaneous patch testing for irritation (ECT; single and/or multiple application protocols) has long been used as an initial in vivo method to screen for possible skin irritation properties of a substance or formulation [2,3]. A guideline for the assessment of skin compatibility of cosmetic products in humans is described by Cosmetics Europe [4] and a comprehensive overview of criteria and test possibilities was published by the DGK working group: Safety and Skin Compatibility of the German Society for Scientific and Applied Cosmetic [5]
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