Registration Dossier
Registration Dossier
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EC number: 435-860-1 | CAS number: 214417-91-1
Endpoint summary
Administrative data
Description of key information
The skin irritation/corrosion study was performed according to OECD Guideline 404 and GLP principles and the eye irritation/corrosion study was performed according to OECD Guideline 405 and GLP principles.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin:
In a skin irritation study performed according to OECD 404, three male rabbits were exposed to 0.5 g of substance semi-occlusively for 4 hours. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.
Exposure to BMH resulted in very slight erythema in the treated skin-area of one of the three rabbits, after 1 hour only. No oedema was noted in any of the animals. There was no evidence of a corrosive effect on the skin. Yellow staining of the treated skin by the test substance was observed on day 1. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. Therefore, BMH is considered to be not skin irritating.
Eye:
In an eye irritation study performed according to OECD 405, three male rabbits were exposed to 49 mg of substance. Observations were made 1, 24, 48 and 72 hours after instillation. Instillation of the test substance into one eye of each of three rabbits resulted in irritation of the conjunctivae, which was seen as redness and chemosis. The irritation had completely resolved within 48 hours in all animals. There was no evidence of ocular corrosion. Remnants of the test substance were present in the eyes of all animals on day 1. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. Therefore, BMH is considered not eye irritating.
Justification for classification or non-classification
Based on the available data, the substance does not have to be classified for skin and eye irritation according to the CLP Regulation (EC) No 1272/2008.
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