Principles for identification of High Potency Category Chemicals for which the Dermal Sensitisation Threshold (DST) approach should not be applied |
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| Institution: | 1. School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, United Kingdom;2. Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, United States;3. B-Safe Toxicology Consulting, 31 Hayway, Rushden, Northants NN10 6AG, United Kingdom;1. School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, L3 3AF, United Kingdom;2. Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, United States;3. Unilever Safety and Environmental Assurance Centre, Colworth Science Park, Sharnbrook, Bedford, MK44 1LQ, United Kingdom;1. School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, L3 3AF, United Kingdom;2. The University of Tennessee, College of Veterinary, 2407 River Drive, Knoxville, TN, 37996, USA;3. Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA;1. University of Manchester, Faculty of Life Sciences, Michael Smith Building, Oxford Road, Manchester, M13 9PT, UK;2. The Procter & Gamble Company, Central Product Safety, Mason Business Center, Mason, OH, 45040, USA;3. DABMEB Consultancy Ltd, Sharnbrook, Bedfordshire, UK;1. DABMEB Consultancy Ltd, Sharnbrook, Bedfordshire, UK;2. B-Safe Toxicology Consulting, Rushden, Northamptonshire, UK |
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| Abstract: | An essential step in ensuring the toxicological safety of chemicals used in consumer products is the evaluation of their skin sensitising potential. The sensitising potency, coupled with information on exposure levels, can be used in a Quantitative Risk Assessment (QRA) to determine an acceptable level of a given chemical in a given product. Where consumer skin exposure is low, a risk assessment can be conducted using the Dermal Sensitisation Threshold (DST) approach, avoiding the need to determine potency experimentally. Since skin sensitisation involves chemical reaction with skin proteins, the first step in the DST approach is to assess, on the basis of the chemical structure, whether the chemical is expected to be reactive or not. Our accompanying publication describes the probabilistic derivation of a DST of 64 μg/cm2 for chemicals assessed as reactive. This would protect against 95% of chemicals assessed as reactive, but the remaining 5% would include chemicals with very high potency. Here we discuss the chemical properties and structural features of high potency sensitisers, and derive an approach whereby they can be identified and consequently excluded from application of the DST. |
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| Keywords: | Skin sensitisation Dermal Sensitisation Threshold (DST) High Potency Category Chemicals (HPC) Sensitisation risk assessment Structure alerts Local Lymph Node Assay (LLNA) Non-animal methods |
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