期刊
REGULATORY TOXICOLOGY AND PHARMACOLOGY
卷 52, 期 1, 页码 35-38出版社
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2007.11.004
关键词
Dermal sensitization; Fragrance; HRIPT; Human; Patch tests; Skin; Human repeated insult patch test
资金
- Research Institute for Fragrance Materials
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 24 h. 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 naive site on the back. Skin reactions at the naive 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. (C) 2007 Elsevier Inc. All rights reserved.
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