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Guidelines and Methods on Safety Testing for Dermatics and Cosmetics

  • Chapter
Dermatopharmacology of Topical Preparations

Abstract

Toxicity testing is generally performed in parallel with the various development phases of new pharmaceutical products or cosmetics. It is a stepwise procedure: it starts (for worker-safety reasons) with the collection of data about the raw materials; the next step is toxicity testing that supports the first clinical trials with preliminary formulations of the test product; the final step is toxicity testing that either supports phase-Ill clinical trials with the final formulation of the test product and fulfills all the requirements for the registration of a new drug or supports the marketing of a new cosmetic product.

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References

  • Arts JHE, Dröge SCM, Bloksma N, Kuper CF (1996) Local lymph node activation in rats after dermal application of the sensitizers 2,4-dinitrochlorobenzene and trimellitic anhydride. Food Chem Toxicol 34:55-62

    Article  PubMed  CAS  Google Scholar 

  • Basketter DA, Gerberick GF, Kimber I, Loveless SE (1996) The local lymph node assay: a viable alternative to currently accepted skin sensitization tests. Food Chem Toxicol 34:985-997

    Article  PubMed  CAS  Google Scholar 

  • Bondesson I, Ekwall B, Hellberg S, Romert L, Stenberg K, Walum E (1989) MEIC - a new international multicenter project to evaluate the relevance to human toxicity of in vitro cytotoxicity tests. Cell Biol Toxicol 5:331-347

    Article  PubMed  CAS  Google Scholar 

  • Bradlaw JA, Wilcox NL (1997) Workshop on eye irritation testing: practical applications of non-whole animal alternatives. Food Chem Toxicol 35:1-11

    Article  CAS  Google Scholar 

  • Brosin A, Wolf V, Mattheus A, Heise H (1997) Use of XTT-assay to assess the cytotoxicity of different surfactants and metal salts in human keratinocytes (HaCaT). Acta Derm Venereol 77:26-28

    PubMed  CAS  Google Scholar 

  • Buehler EV (1965) Delayed contact hypersensitivity in the guinea pig. Arch Dermatol 91:171-177

    Article  PubMed  CAS  Google Scholar 

  • Clemedson C, McFarlane-Abdulla E et al. (1996 a) MEIC evaluation of acute systemic toxicity. Part I. Methodology of 68 in vitro toxicity assay used to test the first 30 reference chemicals. ATLA 24:251-272

    Google Scholar 

  • Clemedson C, McFarlane-Abdulla E et al. (1996b) MEIC evaluation of acute systemic toxicity. Part II. In vitro results from 68 toxicity assays uased to test the first 30 reference chemicals and a comparative cytotoxicity analysis. ATLA 24:273-311

    Google Scholar 

  • COLIPA, the European Cosmetic Toiletry and Perfumery Association (1997 a) Guidelines for the safety assessment of a cosmetic product. COLIPA, Brussels

    Google Scholar 

  • COLOPA, the Europen Cosmetic Toiletry and Perfumery Associatiol (1997b) The Cosmetic directive 76/768/EEC of the council of European communities. Updated version incorporating all amendments until August 30,1997. COLIPA,Brussels

    Google Scholar 

  • Cormier EM, Parker RD, Henson C, Cruse LW, Merritt AK, Bruce RD, Osborne R (1996) Determination of the intra- and interlaboratory reproducibility of the low volume eye test and its statistical relationship to the Draize eye test. Regul Toxicol Pharmacol 23:156-161

    Article  PubMed  CAS  Google Scholar 

  • European Economic Community (1991) Commission directive of 19-Jul-91 modifying the annex to council directive 75/318/EEC on the approximation of the laws of member states relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products. Off J Eur Communities L 270:32-52

    Google Scholar 

  • European Economic Community (1993) Council regulations (EEC) No 2309/93 of 22-Jul-93 laying down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Off J Eur Communities L 214:1-21

    Google Scholar 

  • European Economic Community (1997) Directive 97/18/EG of 17-Apr-97, postponing date of ban on animal testing of cosmetic ingredients and products. Off J Eur Communities L 114:43-44

    Google Scholar 

  • European Medicines Evaluation Agency (1991) Non-clinical local tolerance testing of medicinal products. EEC directive 75/318/EEC. European Medicines Evaluation Agency, London

    Google Scholar 

  • Food and Drug Administration (1998) Guidance for industry. Topical dermatological drug product, NDAs and ANDAs - in vivo bioavailability, bioequivalence, in vitro release, and associated studies. Document 2481DFT.WPD. Food and Drug Administration, Rockville, USA

    Google Scholar 

  • Gettings SD, Dipasquale LC, Bagley DM et al. (1990) The CTFA evaluation of alternatives program. (Phase I) hydro-alcoholic formulations. In Vitro Toxicol 3:293-302

    CAS  Google Scholar 

  • Gettings SD, Dipasquale LC, Bagley DM, Casterton PL, Chudkowski M, Curren RD, Deme-trulias JL, Feder PI, Galli CL, Gay R et al. (1994) The CTFA evaluation of alternatives program. (Phase II) oil/water emulsions. Food Chem Toxicol 32:943-976

    Article  PubMed  CAS  Google Scholar 

  • Gettings SD, Lordo RA, Hintze KL, Bagley DM, Casterton PL, Chudkowski M, Curren RD, Demetrulias JL, Dipasquale LC, Earl LK, Feder PI, Galli CL, Glaza SM, Gordon VC, Janus J, Kurtz PJ, Marenus KD, Moral J, Pape WJ, Renskers KJ, Rheins LA, Roddy MT, Rozen MG, Tedeschi JP, Zyracki J (1996) The CTFA evaluation of alternatives program. (Phase III) surfactant-based formulations. Food Chem Toxicol 34:79-117

    Article  PubMed  CAS  Google Scholar 

  • International Conference on Harmonization (1995 a) Toxicokinetics: the assessment of systemic exposure in toxicity studies. March 1995. International Conference on Harmonization. FDA Rockville USA

    Google Scholar 

  • International Conference on Harmonization (1995 b) Pharmacokinetics: guidance for repeated dose tissue distribution studies. March 1995. International Conference on Harmonization

    Google Scholar 

  • International Conference on Harmonization (1997) M3 Nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals. International Conference on Harmonization

    Google Scholar 

  • Kimber I, Maurer T (1996) Toxicology of contact hypersensitivity. Taylor & Francis, London

    Google Scholar 

  • Kimber I, Weisenberger C (1989) A murine local lymph node assay for the identification of contact allergens. Arch Toxicol 63:274-282

    Article  PubMed  CAS  Google Scholar 

  • Ljunggren B, Maurer T (1991) Photobiologische Prüfungen. In: Hess R (ed) Arzneimittel-toxikologie. Thieme, Stuttgart

    Google Scholar 

  • Loprieno N (1992) Guidelines for safety evaluation of cosmetics ingredients in the EC countries. Food Chem Toxicol 30:809-815

    Article  PubMed  CAS  Google Scholar 

  • Magnusson B, Kligman AM (1969) The identification of contact allergens by animals assay. The guinea pig maximization test. J Invest Dermatol 52:268-276

    PubMed  CAS  Google Scholar 

  • Mandervelt C, Clottens FL, Demedts M, Nemery B (1997) Assessment of the sensitization potential of five metal salts in the murine local lymph node assay. Toxicology 120:65-71

    Article  PubMed  CAS  Google Scholar 

  • Marzulli FN, Maibach HI (1987) Dermatotoxicology, 3rd edn. Hemisphere Publishing Corporation, Washington

    Google Scholar 

  • Marzulli FN, Maibach HI (1998) Dermatotoxicology methods. Taylor & Francis, Washington

    Google Scholar 

  • Maurer T (1983) Contact and photocontact allergens. A manual of predictive methods. Marcel Dekker, New York

    Google Scholar 

  • Maurer T, Hess R (1989) The maximization test for skin sensitization potential - updating the standard protocol and validation of a modified protocol. Food Chem Toxicol 27:807-811

    Article  PubMed  CAS  Google Scholar 

  • Maurer T, Kimber I (1991) Draining lymph node cell activation in guinea pigs: comparisons with the murine local lymph node assay. Toxicology 69:209-218

    Article  PubMed  CAS  Google Scholar 

  • Militzer K (1982) Haut- und Hautanhangsorgane kleiner Laboratoriumstiere. Paul Parey, Berlin

    Google Scholar 

  • Montelius J, Wahlkvist H, Boman A, Fernström P, Grabergs L, Wahlberg J (1994) Experience with the murine local lymph node assay: inability to discriminate between allergens and irritants. Acta Derm Venereol 74:22-27

    PubMed  CAS  Google Scholar 

  • Nilsson R, Maurer T, Redmond N (1993) A standard protocol for phototoxicity testing. Results from an interlaboratory study. Contact Dermatitis 28:285-290

    Article  PubMed  CAS  Google Scholar 

  • Organization for Economic Cooperation and Development (1993) OECD guidelines for testing of chemicals. Organization for Economic Cooperation and Development, Paris

    Google Scholar 

  • Pharmaceutical Affairs Bureau (1990) Guidelines for toxicity studies of drugs manual. Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, Yakuji Nippo, Ltd. Japan

    Google Scholar 

  • Rougier A, Goldberg AM, Maibach HI (1994) In vitro skin toxicology; irritation, phototoxicity, sensitization. Mary Ann Liebert Inc., New York

    Google Scholar 

  • Spielmann H, Lovell WW, Hölzle E et al. (1994) In vitro phototoxicity testing. ATLA 22:314-348

    Google Scholar 

  • Spielmann H, Balls M (1997) A validation study of in vitro photoiritation tests in a joint EU/COLIPA project: preliminary report. In: van Zutphen LFM, Balls M (eds) Animal alternatives, welfare and ethics. Elsevier Science, Amsterdam

    Google Scholar 

  • Spilker B (1991) Extrapolation of preclinical safety data to humans. Drug News 4:211-216

    Google Scholar 

  • Ulrich P, Homey B, Vohr HW (1998) A modified murine local lymph node assay for the differentiation of contact photoallergy from phototoxicity by analysis of cytokine expression in skin-draining lymph node cells. Toxicology 125:149-168

    Article  PubMed  CAS  Google Scholar 

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Authors
  1. Thomas Maurer
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Editor information

Editors and Affiliations

  1. Abteilung Biopharmazie Spirig AG, Pharmazeutische Präparate, 4622, Egerkingen, Switzerland

    Bernard Gabard

  2. Institut für Spital-Pharmazie, Universitätskliniken/Kantonspital Basel, Spitalstraße 26, 4031, Basel, Switzerland

    Christian Surber

  3. Klinik für Hautkrankheiten, Klinikum der Friedrich Schiller-Universität Jena, Erfurter Straße 35, 07740, Jena, Germany

    Peter Elsner

  4. Laboratoires Spirig SA, 109, Boulevard d’Haussonville, 5400, Nancy, France

    Pierre Treffel

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© 2000 Springer-Verlag Berlin Heidelberg

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Maurer, T. (2000). Guidelines and Methods on Safety Testing for Dermatics and Cosmetics. In: Gabard, B., Surber, C., Elsner, P., Treffel, P. (eds) Dermatopharmacology of Topical Preparations. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-57145-9_5

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  • DOI: https://doi.org/10.1007/978-3-642-57145-9_5

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-62960-0

  • Online ISBN: 978-3-642-57145-9

  • eBook Packages: Springer Book Archive

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