Registration Dossier
Registration Dossier
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EC number: 612-953-5 | CAS number: 6218-29-7
Endpoint summary
Administrative data
Description of key information
Skin irritation (Rabbit, OECD TG 404): not skin irritating
[Bayer HealthCare, Bayer Schering Pharma, Report No. A34746 -draft-, 2008-11-26]
Skin irritation (Rat): not skin irritating
[Bayer HealthCare, Bayer Schering Pharma, Report No. A34485, 2008-08-07]
Eye irritation (Rabbit, OECD TG 405): not eye irritating
[Bayer HealthCare, Bayer Schering Pharma, Report No. A34753 -draft-, 2008-05-06]
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
In a skin irritation test in 2 male and 2 female rabbits (500 mg test substance semi-occlusively applied to intact shaved skin for 4 h) no signs of skin irritation could be observed. The mean values of findings (at 20, 48 and 72 h) were 0 for swelling, reddening and scab formation. No clinical signs or effects on body weight were observed.
[Bayer HealthCare, Bayer Schering Pharma, Report No. A34746 -draft-, 2008-11-26]
These data were supported by another study in rats although this study was with respect to skin irritation / corrosion not conducted according to current guidelines (conducted with rats and not with the most sensitive species rabbit, 24 h exposure to the test substance instead of 4 h, 6 rats instead of 3 animals). The single dermal administration of Hydroxyestradienon to male and female rats at the dose of 2000 mg/kg was tolerated without any mortality. One female showed thinning fur on both hind limbs and the abdomen in the last week of the study. No compound-related findings were observed in the other animals with regard to local and clinical observation, determination of body weight and necropsy examination.The test substance was tolerated without any local skin irritations. The mean values of findings (at 24, 48 and 72 h) were 0 for swelling, reddening and scab formation.
[Bayer HealthCare, Bayer Schering Pharma, Report No. A34485, 2008-08-07]
Therefore, Hydroxyestradienon can be regarded as not irritating to the skin. .
The single administration of Hydroxyestradienon into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 52.9 -64.9 mg) results in slight to severe reddening and moderate to severe swelling of the conjunctivae in all animals on administration day. Afterwards slight to moderate conjunctival reddening was noted up to day 4 or 7 and slight swelling was seen until day 2, 3, or 6. All animals were without findings on day 8. 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, 0.6 for conjuntival swelling and 1.1 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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