The Research Institute for Fragrance Materials' human repeated insult patch test protocol

Regulatory Toxicology and Pharmacology : RTP
Valerie T Politano, A M Api

Abstract

With implementation of the dermal sensitization QRA approach for fragrance ingredients, IFRA/RIFM are recommending use of the RIFM standard human repeated insult patch test (HRIPT) protocol for generation of confirmatory human data for the induction of dermal sensitization in a normal human population. Details of this standard HRIPT protocol are provided in this paper. The study protocol consists of two phases--Induction and Challenge. In the Induction phase, patches treated with fragrance ingredients in 75% diethyl phthalate/25% ethanol are applied to backs of volunteers for 24h. Following patch removal there is a 24-h rest period and volunteers are patched again at the same site. This procedure is repeated to achieve 9 applications over a 3-week period. There is an approximate 2-week rest period followed by a Challenge phase of a single 24-h patch application of test article applied to a naïve site on the back. Skin reactions at the naïve site observed at Challenge may be suggestive of dermal sensitization, and a Rechallenge is performed to confirm the nature of the reactivity. This study is designed to confirm the No-Observed-Effect-Level for induction of dermal sensitization in a normal human population.

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Citations

Aug 3, 2013·Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association·J ScognamiglioA M Api
Nov 28, 2013·Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association·J ScognamiglioA M Api
Nov 29, 2014·Cutaneous and Ocular Toxicology·Anne Marie ApiJon Lalko
Sep 23, 2010·Cutaneous and Ocular Toxicology·Sarah Gilpin, Howard Maibach
Dec 2, 2015·Regulatory Toxicology and Pharmacology : RTP·David Basketter, Bob Safford
Oct 31, 2008·Regulatory Toxicology and Pharmacology : RTP·Anne Marie Api, Matthias Vey
Apr 15, 2008·Regulatory Toxicology and Pharmacology : RTP·Anne Marie ApiRobert Safford
Dec 17, 2014·Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association·A M ApiD K Wilcox
Mar 27, 2012·Regulatory Toxicology and Pharmacology : RTP·Judith C MaddenMark T D Cronin
Mar 12, 2013·Regulatory Toxicology and Pharmacology : RTP·Chao YuanYuan Tan
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Oct 24, 2020·Dermatitis : Contact, Atopic, Occupational, Drug·Mihwa NaDavid Basketter

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