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

Regul Toxicol Pharmacol. 2008 Oct;52(1):35-8. doi: 10.1016/j.yrtph.2007.11.004. Epub 2007 Nov 28.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Dermatitis, Allergic Contact / diagnosis*
  • Dermatitis, Allergic Contact / etiology
  • Ethanol / chemistry
  • Female
  • Humans
  • Male
  • Middle Aged
  • No-Observed-Adverse-Effect Level
  • Patch Tests / methods*
  • Perfume / adverse effects*
  • Phthalic Acids / chemistry
  • Risk Assessment / methods
  • Young Adult

Substances

  • Perfume
  • Phthalic Acids
  • Ethanol
  • diethyl phthalate