The Research Institute for Fragrance Materials' human repeated insult patch test protocol.
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.
Politano
Valerie T
VT
Research Institute for Fragrance Materials, Inc., Woodcliff Lake, NJ 07677, USA. vpolitano@rifm.org
Api
Anne Marie
AM
D000293:Adolescent; D000328:Adult; D000368:Aged; D017449:Dermatitis, Allergic Contact / Q000175:diagnosis* / Q000209:etiology; D000431:Ethanol / Q000737:chemistry; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019055:No-Observed-Adverse-Effect Level; D010328:Patch Tests / Q000379:methods*; D010476:Perfume / Q000009:adverse effects*; D010795:Phthalic Acids / Q000737:chemistry; D018570:Risk Assessment / Q000379:methods; D055815:Young Adult
D010476:Perfume; D010795:Phthalic Acids; D000431:Ethanol; C007379:diethyl phthalate