Assuring Consumer Safety without Animal Testing: A Feasibility Case Study for Skin Sensitisation

Abstract

Allergic Contact Dermatitis (ACD; chemical-induced skin sensitisation) represents a key consumer safety endpoint for the cosmetics industry. At present, animal tests (predominantly the mouse Local Lymph Node Assay) are used to generate skin sensitisation hazard data for use in consumer safety risk assessments. An animal testing ban on chemicals to be used in cosmetics will come into effect in the European Union (EU) from March 2009. This animal testing ban is also linked to an EU marketing ban on products containing any ingredients that have been subsequently tested in animals, from March 2009 or March 2013, depending on the toxicological endpoint of concern. Consequently, the testing of cosmetic ingredients in animals for their potential to induce skin sensitisation will be subject to an EU marketing ban, from March 2013 onwards. Our conceptual framework and strategy to deliver a non-animal approach to consumer safety risk assessment can be summarised as an evaluation of new technologies (e.g. ‘omics’, informatics), leading to the development of new non-animal ( in silico and in vitro) predictive models for the generation and interpretation of new forms of hazard characterisation data, followed by the development of new risk assessment approaches to integrate these new forms of data and information in the context of human exposure. Following the principles of the conceptual framework, we have been investigating existing and developing new technologies, models and approaches, in order to explore the feasibility of delivering consumer safety risk assessment decisions in the absence of new animal data. We present here our progress in implementing this conceptual framework, with the skin sensitisation endpoint used as a case study.

Emulsification and antioxidation of biosurfactant extracts from Chinese medicinal herbs fermentation in vitro

“…SPATs were performed using the method described in the literature to estimate the safety and sensitivity of skin moisturizers (24,25). Briefly, 30 volunteers participated in this investigation.…”

Read‐across to rank skin sensitization potential: subcategories for the Michael acceptor domain

“…There is a general agreement that any substance that binds irreversibly to proteins has the potential to be a sensitizer (1). Yet, in order to determine if a chemical will be an in vivo sensitizer, other issues such as bioavailability and other aspects of immunogenicity may have to be considered in a holistic approach (2). Currently, what these other issues are and how to measure or scale them is under debate (3).…”

Assuring consumer safety without animals

“…Allergic contact dermatitis is a serious eczematous skin reaction resulting from a specific, delayed type hypersensitivity response to a small molecule (chemical) allergen. 37 Maxwell et al 38 have recently published a proposal for a possible risk assessment framework for skin allergy that would not involve the use of animal tests. Such an approach aims to integrate data from several new models and technologies to study key aspects of consumer exposure (including the dermal kinetics of chemicals applied to the skin) together with information on effects on the underlying biology of skin sensitization such as chemical reactivity (e.g., in silico predictive models of chemical reactivity and chemical assessment of peptide reactivity) and immune cell activation (epidermal inflammation, dendritic cell activation and T-cell proliferation).…”