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EC number: 695-797-0 | CAS number: 93601-86-6
Results Pre-screen test:
In the first pre-screen test body weight loss was noted for all animals. Since no irritation and no clinical signs were noted (except for bald forepaws in one animal), toxicological relevance of the body weight loss was doubted also since most of the animals had starting body weights higher than normal. Therefore the pre-screen test was extended with three concentrations.
In this second pre-screen test, the body weight loss noted for some animals at 25 and 50% was not considered to be toxicologically relevant as the body weight loss was very slight and no other signs of systemic toxicity were noted. Redness was noted for both animals at 50% on Day 5, and scabs were noted for both animals on Day 6. No signs of systemic toxicity were observed in any of the animals examined, and no irritation was noted for any other animal. White test substance remnants were visible on the ears of all animals on Days 1-3, which did not prevent scoring of the ears. Scabbing was seen for two animals at 50% on Day 6. Variations in ear thickness during the observation period remained within the acceptable range (i.e. less than the maximum of 25% from Day 1 pre-dose values). Based on these results, the highest test substance concentration selected for the main study was a 50% concentration (highest technically possible concentration for a solid).
An LLNA skin sensitisation study was performed according to OECD 429 and according to GLP principles with the substance. Reliable positive and negative controls were included. Based on the results of pre-screen tests, three experimental groups of five female CBA/J mice were treated with test substance concentrations of 10, 25 or 50% w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (dimethylformamide). No irritation of the ears was observed in any of the animals examined. The auricular lymph nodes of four animals at 50% appeared larger in size as compared to the other animals. This increase in size did not show a clear relation to the DPM/animal values. No macroscopic abnormalities of the surrounding area were noted in any of the animals.
Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 410, 410 and 722 DPM, respectively. The mean DPM/animal value for the vehicle control group was 367 DPM. Only four animals of the control group were available for DPM measurements as one animal died during 3H-methyl thymidine injection procedure. Variability in measured DPM values was within the expected variation for this type of study. The SI values calculated for the substance concentrations 10, 25 and 50% were 1.1, 1.1 and 2.0, respectively. Based on these data, the substance is considered not be a skin sensitiser, as the SI was shown to be < 3 when tested up to and including 50%. The substance does not need to be classified as skin sensitiser according to GHS and CLP.
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