US EPA

1315340 

Journal Article 

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

Politano, VT; Api, AM 

2008 

1 

Regulatory Toxicology and Pharmacology
ISSN: 0273-2300
EISSN: 1096-0295 

52 

1 

35-38 

English 

18177987 

10.1016/j.yrtph.2007.11.004 

WOS:000261437600004 

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. 

Dermal sensitization; Fragrance; HRIPT; Human; Patch tests; Skin; Human repeated insult patch test