International regulatory requirements for skin sensitization testing

Abstract

Skin sensitization test data are required or considered by chemical regulation authorities around the world. These data are used to develop product hazard labeling for the protection of consumers or workers and to assess risks from exposure to skin-sensitizing chemicals. To identify opportunities for regulatory uses of non-animal replacements for skin sensitization tests, the needs and uses for skin sensitization test data must first be clarified. Thus, we reviewed skin sensitization testing requirements for seven countries or regions that are represented in the International Cooperation on Alternative Test Methods (ICATM). We noted the type of skin sensitization data required for each chemical sector and whether these data were used in a hazard classification, potency classification, or risk assessment context; the preferred tests; and whether alternative non-animal tests were acceptable. An understanding of national and regional regulatory requirements for skin sensitization testing will inform the development of ICATM's international strategy for the acceptance and implementation of non-animal alternatives to assess the health hazards and risks associated with potential skin sensitizers.

Evaluation of in vitro testing strategies for hazard assessment of the skin sensitization potential of “real‐life” mixtures: The case of henna‐based hair‐colouring products containing p‐phenylenediamine

“…In addition, there are geographical differences regarding the amounts of PPD that are acceptable in cosmetics. For instance, in Europe, PPD is permitted in concentrations up to 2%, whereas, in the United States, where no testing or data regarding skin sensitization potential are required for cosmetics, no limits are provided for hair colourants . Thus, no worldwide consensus has been established for the tolerable limits of this chemical in cosmetics.…”

“…Hazard assessment of the skin sensitization potential of chemicals and/or "real-life" mixtures that may come into dermal contact, such as cosmetics, is mandatory in risk evaluation for classification and labelling for regulatory purposes. [1][2][3] Its objective is to identify potential health risks resulting from the use and handling of materials by consumers and workers, in order to ensure appropriate labelling of hazardous products and protection of public health. 3,4 Contact allergy to chemicals is common, affecting, for example, 27% of the general population in Europe.…”

“…[1][2][3] Its objective is to identify potential health risks resulting from the use and handling of materials by consumers and workers, in order to ensure appropriate labelling of hazardous products and protection of public health. 3,4 Contact allergy to chemicals is common, affecting, for example, 27% of the general population in Europe. 5 The clinical manifestation is allergic contact dermatitis (ACD).…”

Integrated Approaches to Testing and Assessment

“…One of the workshop aims was mapping the regulatory requirements for skin sensitisation across jurisdiction and sectors. It was recognised that differences in regulatory requirements exist, but chances to satisfy such requirements with the use of non‐animal methods and defined approaches were also emphasised . The workshop participants also indicated that international harmonization and standardisation are essential to guarantee regulatory uptake of data generated with defined approaches and their use within IATA and recommended the development of an evaluation framework that would allow an independent and consistent evaluation of the defined approaches documented in Annex I to OECD Guidance Document 256 and any other upcoming promising defined approaches.…”

Identification of Potential Skin Sensitizers in Myrrh

“…A systematic investigation of the skin sensitization adverse effects of plants like myrrh can be extremely costly in terms of resources and animal welfare. Furthermore, regulatory agencies worldwide have been intensifying efforts aimed to reduce the use of animal methods for the safety evaluation of ingredients in cosmetic and personal care preparations [11].…”