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HERO ID
1315340
Reference Type
Journal Article
Title
The Research Institute for Fragrance Materials' human repeated insult patch test protocol
Author(s)
Politano, VT; Api, AM
Year
2008
Is Peer Reviewed?
1
Journal
Regulatory Toxicology and Pharmacology
ISSN:
0273-2300
EISSN:
1096-0295
Volume
52
Issue
1
Page Numbers
35-38
Language
English
PMID
18177987
DOI
10.1016/j.yrtph.2007.11.004
Web of Science Id
WOS:000261437600004
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.
Keywords
Dermal sensitization; Fragrance; HRIPT; Human; Patch tests; Skin; Human repeated insult patch test
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