Registration Dossier

Administrative data

Description of key information

Primary irritation patch test: irritating

Repeat insult human patch test: not sensitising

Additional information

Data on skin irritation in humans is available from a primary irritation patch test performed with 0.3, 1.0 and 3.0% of the test substance in water with 20 volunteers of the general population (Carabello, 1980). The results demonstrate significant skin irritation at all doses especially 24 hours after application in most of the individuals. The skin reactions observed did not fully resolve in all subjects until the last reading point 48 h after application.

Information on skin sensitisation is available from 2 repeat insult human patch tests, both sponsored by industry. In the newer one 52 individuals of the general population were exposed to a test substance concentration of 1% (Stephens, 2008). Only local irritation reactions were observed 48 and 96 hours after challenge in 24/52 and 21/52 individuals, respectively. No evidence for sensitisation was found. This result is supported by the second study (Ter Haar, 1983b) in which 88 individuals of the general population were repeatedly exposed to 8% test substance for induction and once to 4% for challenge. No evidence for contact sensitisation was found in this study, either.