Cyclopropanecarboxylic acid, 2-[1-(3,3-dimethylcyclohexyl)ethoxy]-2-methylpropyl ester

Endpoint summary

Description of key information

Sensitisation data (humans) : no sensitisation at 15% in vehicle in 97/97 humans, HRIPT, 2006

Additional information

Supporting study : Sensitisation data (humans) - HRIPT, 2006 :The study was conducted as a human repeat insult patch test under occlusive dressing according to: US FDA Regulation: CFR Title 21, Parts 50, 56 and 312 under GLP conditions. The test article (consisting of the test substance at 15% concentration) was tested was to determine the irritation and/or sensitisation potential of the test article after repeated application under occlusive patch test conditions to the skin of human subjects (exclusive panel). A total of 110 volunteer subjects, 20 males and 90 females ranging in age from 18 to 74 years, were empanelled for the test. Applicant assessment indicates that the test protocol could be considered: equivalent or similar to the RFIM human repeated insult patch test protocol cited in: V.T. Politano & A.M. Api, Regulatory Toxicology and Pharmacology 52 (2008) 35–38. 0.2 mL of the test article was applied every Monday, Wednesday and Friday until 9 applications had been made with the use of occlusive dressing to increase test sensitivity applied to the upper arm in the induction phase. The subjects were instructed to remove the patch 24 hours after application. Twenty-four hour rest periods followed the Tuesday and Thursday removals and 48-hour rest periods followed each Saturday removal. Subjects returned to the Testing Facility and the site was scored by a trained examiner just prior to the next patch application.If a subject developed a positive reaction of a level 2 erythema or greater during the Induction phase or if, at the discretion of the Study Director, the skin response warranted a change in site, the patch was applied to a previously unpatched, adjacent site for the next application. If a level 2 reaction or greater occurred at the new site, no further applications were made. However, any reactive subjects were subsequently Challenge patch tested. In the challenge phase: after a rest phase of ca. 2 weeks (no applications) the challenge patch was applied to a previously unpatched (virgin) site. The site was scored at 24 and 72 hours after application. All subjects were instructed to report any delayed skin reactivity that occurred after the final challenge patch reading. 13 out of 110 panellist discontinued for reasons unrelated to the study (all score = 0 prior to discontinuing). 97 out of 97 panellists that concluded the study indicated a maximum score = 0 with no other observations noted. There was no skin reactivity observed at any time during the course of the study.Under the conditions of this study, there was no evidence of sensitisation and of irritation to the test item (which consisted of the test substance at 15% concentration in vehicle).

Cross reference to Section: 7.4.1 : Skin Sensitisation

Further literature references:

(1) V.T. Politano & A.M. Api, Regulatory Toxicology and Pharmacology 52 (2008) 35–38