Skin Sensitization in Chemical Risk Assessment
نویسندگان
چکیده
Anne Marie Api Research Institute for Fragrance Materials, Inc. (RIFM), Woodcliff Lake, New Jersey, USA J.H.E. Arts TNO Quality of Life, Zeist, Netherlands Harmonization Project Document No. 5 4 David Basketter Unilever Safety and Environmental Assurance Centre, Sharnbrook, Bedford, United Kingdom Jonathan Chen Antimicrobials Division, Office of Pesticide Programs, Environmental Protection Agency, Washington, DC, USA Amanda Cockshott Health & Safety Executive, Merseyside, United Kingdom W.H. De Jong National Institute for Public Health and the Environment (RIVM), Bilthoven, Netherlands Jeanne Duus Johansen National Allergy Research Centre, Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark G. Frank Gerberick The Procter & Gamble Company, Cincinnati, Ohio, USA Peter Griem Corporate Product Safety, Clariant Produkte (Deutschland) GmbH, Sulzbach, Germany C.F. Kuper TNO Quality of Life, Zeist, Netherlands Carola Lidén Stockholm Centre for Public Health and Karolinska Institutet, Stockholm, Sweden Timothy F. McMahon Antimicrobials Division, Office of Pesticide Programs, Environmental Protection Agency, Washington, DC, USA Grace Patlewicz European Chemicals Bureau, Joint Research Centre, European Commission, Ispra, Italy Cindy A. Ryan The Procter & Gamble Company, Cincinnati, Ohio, USA Masahiro Takeyoshi Chemicals Assessment Center, Chemicals Evaluation and Research Institute, Saitama, Japan H. Van Loveren National Institute for Public Health and the Environment (RIVM), Bilthoven, and Maastricht University, Maastricht, Netherlands Skin Sensitization in Chemical Risk Assessment 5 Hans-Werner Vohr Bayer HealthCare AG, Wuppertal-Elberfeld, Germany Harmonization Project Document No. 5 6 LIST OF ACRONYMS AND ABBREVIATIONS ACD allergic contact dermatitis BMD benchmark dose BMD10 benchmark dose for 10% response BrdU 5-bromo-2 -deoxyuridine CAS Chemical Abstracts Service CFR Code of Federal Regulations (USA) COLIPA European Cosmetic, Toiletry and Perfumery Association DC dendritic cell DfW Derek for Windows DNCB dinitrochlorobenzene EC European Commission EC3 effective concentration inducing a stimulation index of 3 ELISA enzyme-linked immunosorbent assay EU European Union FIFRA Federal Insecticides, Fungicide, and Rodenticide Act (USA) GHS Globally Harmonized System of Classification and Labelling of Chemicals GPMT guinea-pig maximization test HDI hexamethylene diisocyanate HMT human maximization test HRIPT human repeat/repeated insult patch test HTS high throughput screening ICCVAM Interagency Coordinating Committee on the Validation of Alternative Methods IFN interferon IFRA International Fragrance Association IL interleukin INCI International Nomenclature of Cosmetic Ingredients IPCS International Programme on Chemical Safety LC Langerhans cell LLNA local lymph node assay LOAEL lowest-observed-adverse-effect level LOEL lowest-observed-effect level MET minimum elicitation threshold MET10 minimum elicitation threshold inducing a threshold response in 10% of the subjects tested MHC major histocompatibility complex NESIL no-expected-sensitization induction level NOEL no-observed-effect level NONS Notification of New Substances Regulations (United Kingdom) OECD Organisation for Economic Co-operation and Development OPP Office of Pesticide Programs (USEPA) OPPTS Office of Prevention, Pesticides and Toxic Substances (USEPA) OXA oxazolone PA phthalic anhydride Skin Sensitization in Chemical Risk Assessment 7 PBMC-DC peripheral blood mononuclear cell-derived dendritic cells PPRA peroxidase peptide reactivity assay QRA quantitative risk assessment QRT-PCR quantitative real-time polymerase chain reaction QSAR quantitative structure–activity relationship RAI relative alkylation index REACH Registration, Evaluation, Authorisation and Restriction of Chemicals RIFM Research Institute for Fragrance Materials ROAT repeat open application insult test SAF sensitization assessment factor SAR structure–activity relationship SI stimulation index SLS sodium lauryl sulfate s-RfD sensitization reference dose TDI toluene diisocyanate TGD technical guidance document Th1 Thelper1 Th2 Thelper2 TIMES TImes MEtabolism Simulator TIMES-SS TIMES for skin sensitization TMA trimellitic anhydride USA United States of America USEPA United States Environmental Protection Agency WHO World Health Organization
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