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EC number: 251-995-5 | CAS number: 34396-03-7
Skin irritation/corrosion (OECD 404, GLP, RL1), rabbit: not irritatingEye irritation (OECD 405, GLP, RL1), rabbit: not irritating
In the available key study the test item (91.5% pure) was tested for eye irritation according to the OECD TG 404 and in compliance with GLP (LPT, 2002b). 0.5 ml of the test material was applied to the shaved, intact skin of three Himalayan rabbits and was covered using a semi-occlusive dressing for four hours. After four hours the dressing was removed and no washing was required. An erythema (grade 1) was observed in one animal from 60 minutes up to 72 hours after the patch removal. There were no substance-related changes at the examination time points of 1, 24, 48 and 72 hours for the other two animals. There were no signs of systemic toxicity. Hence, the test item was considered non-irritating to the skin.
In the available key study the test item was tested for eye irritation according to the OECD TG 405 and in compliance with GLP (Hoechst, 1991). Three New Zealand White rabbits received the unchanged test material, which was rinsed off the eyes 24 hours after instillation. One hour after exposure the conjunctiva had diffuse redness and partial eversion of the eyelids (conjunctival score = 2) in all animals. After 24 hours two animals still had marked hyperaemia (conjunctival score = 1) that were fully reversible within 48 h. Thus, the mean score over 24, 48 and 72 h out of all 3 animals for conjunctival redness is 0.2. Scores for cornea, iris, and chemosis were 0 at any reading time points in all animals. Based on these findings classification for eye irritation is not warranted.
The available data on skin and eye irritation are reliable and suitable for classification. Based on this data, classification for skin irritation/corrosion and eye irritation according to 67/584/EEC and EC/1272/2008 is not warranted.
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