The human repeated insult patch test in the 21st century: A commentary

References

• Menné T, Wahlberg JE. Risk assessment failures of chemicals commonly used in consumer products. Contact Dermatitis. 2002; 46:189–190.
   PubMed Web of Science ®Google Scholar
• Dillarstone A. Cosmetic preservatives. Contact Dermatitis. 1997; 37:190.
   PubMed Web of Science ®Google Scholar
• Kimber I, Basketter DA. Contact sensitization: a new approach to risk assessment. Hum Ecol Risk Assess. 1997; 3:385–395.
   Web of Science ®Google Scholar
• Basketter DA, Clapp C, Jefferies D, Safford RJ, Ryan CA, Gerberick GF, Dearman RJ, Kimber I. Predictive identification of human skin sensitization thresholds. Contact Dermatitis. 2005; 53:260–267.
   PubMed Web of Science ®Google Scholar
• Gerberick GF, Robinson MK, Ryan CA, Dearman RJ, Kimber I, Basketter DA, Wright Z, Marks JG. Contact allergenic potency: correlation of human and local lymph node assay data. Am J Contact Dermatitis. 2001; 12:156–161.
   PubMedGoogle Scholar
• Felter SP, Robinson MK, Basketter DA, Gerberick GF. A review of the scientific basis for default uncertainty factors for use in quantitative risk assessment of the induction of allergic contact dermatitis. Contact Dermatitis. 2002; 47:257–266.
   PubMed Web of Science ®Google Scholar
• Felter SP, Ryan CA, Basketter DA, Gerberick GF. Application of the risk assessment paradigm to the induction of allergic contact dermatitis. Reg Toxicol Pharmacol. 2003; 37:1–10.
   PubMed Web of Science ®Google Scholar
• Basketter DA, Kimber I. Predictive test for irritants and allergens and their use in quantitative risk assessment. In: Frosch PJ, Menné T, Lepoittevin J-P, eds. Contact Dermatitis, 4th Edition; Heidelberg, Germany: Springer Verlag. 2006:179–188.
   Google Scholar
• Basketter DA, Clapp CJ, Safford BJ, Jowsey IR, McNamee PM, Ryan CA, Gerberick GF. Preservatives and skin sensitization quantitative risk assessment: risk benefit considerations. Dermatitis. 2008; 19:20–27.
   PubMed Web of Science ®Google Scholar
• Scientific Committee on Cosmetic Products and Non-Food Products. SCCNFP/0120/99, Final: Opinion concerning the predictive testing of potentially cutaneous sensitising cosmetic ingredients or mixtures of ingredients, adopted by the SCCNFP during the 11th plenary session of 17 February 2000, Brussels, Belgium. http://ec.europa.eu/health/ph_risk/committees/sccp/docshtml/sccp_out113_en.htm (accessed April 2009).
   Google Scholar
• Marzulli FN, Maibach HI. Antimicrobials: experimental contact sensitization in man. J Soc Cosmet Chem. 1973; 24:399–421.
   Web of Science ®Google Scholar
• Marzulli FN, Maibach HI. Use of graded concentrations in studying skin sensitizers—experimental contact sensitization in man. Food Cosmet Toxicol. 1974; 12:219–227.
   PubMedGoogle Scholar
• Marzulli FN, Maibach HI. Contact allergy—predictive testing of fragrance ingredients in humans by Draize and maximization methods. J Environ Pathol Toxicol. 1980; 3:235–245.
   PubMedGoogle Scholar
• Stotts J. Planning, conduct and interpretation of human predictive sensitization patch tests. In: Drill VA, Lazar P. Current Concepts in Cutaneous Toxicity; St. Louis, MO: Academic Press (Elsevier). 1980.
   Google Scholar
• Marzulli FN, Maibach HI. Further studies of vehicles and elicitation concentration in experimental contact sensitization testing in humans. Contact Dermatitis. 1980; 6:131–133.
   PubMed Web of Science ®Google Scholar
• McNamee PM, Basketter DA, Gerberick GF, Gilpin DA, Hall BM, Jowsey I, Robinson MK. A review of critical factors in the conduct and interpretation of the human repeat insult patch test. Reg Toxicol Pharmacol. 2008; 52:24–34.
   PubMed Web of Science ®Google Scholar
• World Medical Association. Declaration of Helsinki. Recommen dation guiding physicians in biomedical research involving human subjects. Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964; amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975, the 35th World Medical Assembly, Venice, Italy, October 1983, and the 41st World Medical Assembly, Hong Kong, September 1989. Proceedings of the XXVI Conference, Geneva, Switzerland, 1993.
   Google Scholar
• Henderson CR, Riley EC. Certain statistical considerations in patch testing. J Invest Dermatol. 1945; 6:227–229.
   Web of Science ®Google Scholar
• Api AM, Basketter DA, Cadby PA, Cano M-F, Ellis G, Gerberick GF, Griem P, McNamee PM, Ryan CA, Safford B. Dermal sensitization quantitative risk assessment (QRA) for fragrance ingredients. Reg Toxicol Pharmacol. 2008; 52:3–23.
   PubMed Web of Science ®Google Scholar
• Schneider K, Akkan Z. Quantitative relationship between the local lymph node assay and human skin sensitization assays. Reg Toxicol Pharmacol. 2004; 39:245–255.
   PubMed Web of Science ®Google Scholar
• Griem P, Goebel C, Scheffler H. Proposal for a risk assessment methodology for skin sensitization based on sensitization potency data. Reg Toxicol Pharmacol. 2003; 38:269–290.
   PubMed Web of Science ®Google Scholar
• National Institute of Environmental Health Sciences. Validation status of new versions and application of the murine local lymph node assay; a test method for assessing the allergenic contact dermatitis potential of chemicals and products. Peer review panel report. May 2008. http://iccvam.niehs.nih.gov/docs/immunotox_docs/LLNAPRPRept2008.pdf (accessed April 2009).
   Google Scholar
• Api A M, Lalko J, Letizia CS, Politano VT. The use of human data when conducting dermal sensitization quantitative risk assessments for fragrance ingredients; how well does the LLNA predict human NOELs? Toxicologist. 2009; 108:30–32.
   Google Scholar
• Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Report. The murine local lymph node assay: a test method for assessing the allergic contact dermatitis potential of chemicals/compounds. NIH Publication No. 99-4494; National Institutes of Health, Bethesda, MD. 1999.
   Google Scholar
• Basketter DA, Casati S, Cronin MTD, Diembeck W, Gerberick GF, Hadgraft J, Kasting G, Marty JP, Nikolaidis E, Patlewicz G, Pease C, Roberts DW, Roggen E, Rovida C, van der Sandt J. Skin sensitisation and epidermal disposition. Altern Lab Anim. 2007; 35:137–154.
   PubMed Web of Science ®Google Scholar
• Basketter DA, Gerberick GF, Kimber I. Skin sensitisation, vehicle effects and the local lymph node assay. Food Chem Toxicol. 2001; 39:621–627.
   PubMed Web of Science ®Google Scholar
• Jowsey IR, Clapp CJ, Safford B, Gibbons BT, Basketter DA. The impact of vehicle on the relative potency of skin sensitising chemicals in the local lymph node assay. Food Chem Toxicol. 2008; 27:67–75.
   Google Scholar
• Jenkins HL, Adams MG. Progressive evaluation of skin irritancy of cosmetics using human volunteers. Int J Cosmet Sci. 1989; 11:141–149.
   PubMed Web of Science ®Google Scholar
• Walker AP, Basketter DA, Baverel M, Diembeck W, Matthies W, Mougin D, Paye M, Rothlisburger R, Dupuis J. Test guideline for assessment of skin compatibility of cosmetic finished products in man. Food Chem Toxicol. 1996; 34:551–560.
   Google Scholar
• Walker AP, Basketter DA, Baverel M, Diembeck W, Matthies W, Mougin D, Paye M, Rothlisburger R, Dupuis J. Test guidelines for assessment of skin tolerance of potentially irritant cosmetic ingredients in man. Food Chem Toxicol. 1997; 35:1099–1106.
   PubMed Web of Science ®Google Scholar
• Marzulli FN, Maibach HI. Contact allergy: predictive testing of fragrance ingredients in human by Draize and maximization methods. J Environ Pathol Toxicol. 1980; 3:235–245.
   PubMedGoogle Scholar
• Friedmann PS, Moss C, Shuster S, Simpson JM. Quantitative relationships between sensitizing dose of DNCB and reactivity in normal subjects. Clin Exp Immunol. 1983; 53:709–715.
   PubMed Web of Science ®Google Scholar
• Cassimos C, Kanakoudi-Tsakalidis F, Spyroglou K, Ladianos M, Tzaphi R. Sensitisation to 2,4 dinitrochlorobenzene (DNCB) in the first months of life. J Clin Immunol. 1980; 3:111–113.
   Google Scholar
• Kligman AM. The identification of contact allergens by human assay. III. The maximization test: a procedure for screening and rating contact sensitizers. J Invest Dermatol. 1966; 47:393–409.
   PubMed Web of Science ®Google Scholar
• Kligman AM. Poison ivy (Rhus) dermatitis; an experimental study. Arch Dermatol. 1958; 77:149–180.
   Web of Science ®Google Scholar
• Basketter DA, Jefferies D, Safford RJ, Gilmour NJ, McFadden J, Chansinghakul W, Duangdeeden I, Kullavanijaya P. The impact of exposure variables on the induction of skin sensitisation. Contact Dermatitis. 2006; 55:178–185.
   PubMed Web of Science ®Google Scholar
• Carlsen BC, Andersen KE, Menné T, Johansen JD. Patients with multiple contact allergies: a review. Contact Dermatitis. 2008; 58:1–8.
   PubMed Web of Science ®Google Scholar
• Schnuch A, Brasch J, Uter W. Polysensitisation and increased susceptibility in contact allergy: a review. Allergy. 2008; 63:156–167.
   PubMed Web of Science ®Google Scholar
• Calvin G. Risk management case history—detergents. In: Richardson ML, ed. Risk Management of Chemicals; London: Royal Society of Chemistry. 1992:120–136.
   Google Scholar
• Nusair TL, Danneman P J, Stotts J, Bay PHS. Consumer products: risk assessment process for contact sensitization. Toxicologist. 1988; 8:258–264.
   Google Scholar