Registration Dossier
Registration Dossier
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EC number: 927-431-5 | CAS number: 1178896-82-6
Endpoint summary
Administrative data
Description of key information
Skin irritation (Rat, GLP): not skin irritating
[Nihon Schering K.K., Report No. A07761, 2004-04-23]
Eye irritation (Rabbit, GLP, OECD TG 405): not eye irritating
[Nihon Schering K.K., Report No. A08305, 2004-04-23]
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 Dienolacetat-ketal 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. No local intolerance reactions at the application sites were observed. The mean value grades across the time points (24, 48 and 72 h after removal of the pad) were 0 both for reddening/scab formation and for swelling.
Although the study was with respect to skin irritation / corrosion not conducted according to current guidelines and with the most sensitive species rabbit Dienolacetat-ketal can be regarded as not irritating to the skin since 24 h exposure to the test substance (instead of 4 h) under occlusive conditions (instead of semi-occlusive conditions) was tolerated by 6 rats (instead of 3 animals) without any local skin reactions.
The single administration of Dienolacetat-ketal into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 36.2 -44.1 mg) results in slight reactions of the conjunctivae on administration day. On day 2 (24 h after administration) only slight conjunctival reddening was seen in two out of four animals and from day 3 onwards, all animals were without findings.
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 and iris and conjuntival swelling and 0.15 for 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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