Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
The in vivo skin irritation/corrosion study was performed according to OECD Guideline 404 and GLP principles and the in vivo 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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
Three male rabbits were exposed to B508 for 4 hours using a semi-occlusive dressing, according to OECD 404 test guideline and GLP principles. No skin irritation was caused by 4-hour exposure to the test substance. Blue staining of the treated skin by the test substance was observed throughout the observation period which did not hamper the scoring of the skin reactions. No test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals and no mortality occurred. B508 is not irritating to skin and no classification is needed according to EC regulation 1272/2008.
Eye irritation:
B508 was instilled into one eye of three rabbits, according to OECD 405 test guideline and GLP principles. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. Instillation of B508 resulted in effects on the cornea, iris and conjunctivae that resolved within 7 days and did not trigger classification according to EC regulation 1272/2008.
Justification for selection of skin irritation / corrosion endpoint:
One key study is available.
Justification for selection of eye irritation endpoint:
One key study is available.
Justification for classification or non-classification
Based on the results mentioned above, B508 does not have to be classified and has no obligatory labelling requirement for skin and eye irritation in accordance with Regulation EC 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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