Registration Dossier
Registration Dossier
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EC number: 259-701-7 | CAS number: 55542-27-3
Endpoint summary
Administrative data
Description of key information
No internal Guideline skin irritation study was conducted.
However, within an acute dermal toxicity study in rats also local findings were recorded and evaluated (Rat, GLP, TG OECD 402): not skin irritating
[Kesla Forschung & Service KG, Report No. A03975, 2001-04-10]
Eye irritation study (Rabbit, GLP, OECD TG 405): not eye irritating
[Kesla Forschung & Service KG, Report No. A03976, 2001-04-10]
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 the test substance (ZK 57797) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. No compound-related local findings were observed. None of the animals showed alterations of the skin (edema and/or erytthema) on the administration area. Although the acute dermal toxicity study was with respect to skin irritation / corrosion not conducted according to current guidelines and with the most sensitive species rabbit Hydroxypropyltesto can be regarded as not irritating to the skin since 24 h exposure to the test substance (instead of 4 h) under occlusive (instead of semiocclusive) conditions was tolerated by 6 rats (instead of 3 animals) without any local skin reactions.
The single administration of 0.1 g Hydroxypropyltesto into one eye of male rabbits resulted in slight reddening of the conjunctivae in all animals and in slight swelling of the conjunctivae in one animal on administration day. All animals were without findings from day 2 onwards.
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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