Registration Dossier
Registration Dossier
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EC number: 617-449-9 | CAS number: 83196-58-1
Endpoint summary
Administrative data
Description of key information
Skin irritation (Rat, GLP): not skin irritating
[Schering AG, Report No. X027 -draft-, 1995-07-19]
Eye irritation (Rabbit, GLP, OECD TG 405): not eye irritating
[Schering AG, Report No. X030 -draft-, 1995-07-20]
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
The single dermal administration of AD-Cyanhydrin-3 -Ethyleneketal to male and female rats at the dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs.
Although the study was with respect to skin irritation / corrosion not conducted according to current guidelines and with the most sensitive species rabbit AD-Cyanhydrin-3 -Ethyleneketal can be regarded as not irritating to the skin since 24 h exposure to the test substance (instead of 4 h) was tolerated by 6 rats (instead of 3 animals) without any local skin reactions.
The single administration of AD-Cyanhydrin-3 -Ethyleneketal into the right eye of 4 female rabbits with a volume of 0.1 ml/eye (corresponding to 58.6 -67.9 mg) resulted in very slight transient irritation in 2 animals on administration day. These animals were without findings from day 2 onwards. The other 2 females showed no signs of irritation at all.
According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea, iris, conjuntival swelling and conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
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