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EC number: - | CAS number: -
Table 1: Challenge Data
Test Material Challenge
HCA Challenge Control
HCA Vehicle - Acetone
IT – Dermal irritation outside of test site
Table 2: Rechallenge data
24 Hours Observation
48 Hours Observation
Test Material Rechallenge
Vehicle - propylene glycol
The dermal sensitisation potential of the test material was investigated in the Buehler test conducted on male and female Hartley guinea pigs, in accordance with OECD 406, EU Method B.6 and EPA OPPTS 870.2600.
Ten male and ten female guinea pigs were topically treated with the neat test material once per week for three consecutive weeks. The challenge test was performed after a rest period of two weeks. The challenge test was administered neat to the twenty animals in the test group and ten (five male and five female) naïve challenge control animals. Challenge responses were recorded at 24 and 48 hours. Following a seven day rest period, a rechallenge was performed with the twenty test animals and ten naïve test rechallenge control animals. The rechallenge animals were topically treated with the test material at 100 % and 50 % in propylene glycol.
A positive control group treated withα-Hexylcinnamaldehyde (HCA) was included to demonstrate the validity of the study.
Under the conditions of the test, the test material was determined to be a contact sensitiser at the concentrations tested. The results of the positive control demonstrated that a valid test was performed.
In accordance with Regulation EC 1272/2008 (CLP), the test material is classified as H317 Category 1B “May cause an allergic skin reaction” based on the observations in the available in vivo studies.
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