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EC number: 947-839-7 | CAS number: -
The skin sensitisation potential of Gurjun balsam oil (Gurjunene) was tested according to OECDTG 429. Three experimental groups of five female CBA/J mice were treated with 25µL test item concentrations of 1, 2 or 5% w/w on three consecutive days, by open application on the ears. Test item concentrations selected for the main study were based on the results of a prescreen test. Five vehicle control animals were similarly treated, but with the vehicle alone (AcOO). Very slight erythema and/or scaliness was noted was considered not to have a toxicologically significant effect on the activity of the nodes. No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size. No macroscopic abnormalities of the surrounding area were noted for any of the animals. Body weights and body weight gain of experimental animals remained in the same range as controls over the main study period. Mean DPM/animal values for the experimental groups treated with test item concentrations 1, 2 and 5% were 579, 1107 and 2179 DPM respectively. The mean DPM/animal value for the vehicle control group was 298 DPM. The SI values calculated for the test item concentrations 1, 2 and 5% were 1.9, 3.7 and 7.3 respectively. The data showed a dose-response and an EC3 value (the stimated test item concentration that will give a SI =3) of 1.6% was calculated.Based on these results, Gurjun balsam oil (Gurjunene) needs to be classified as category 1A skin sensitiser according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
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