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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation (Rat, GLP): not skin irritating
[Schering AG, Report No. X318 -draft-, 1998-10-15]
Eye irritation (Rabbit, GLP, OECD TG 405): not eye irritating
[Schering AG, Report No. X360 -draft-, 1999-07-21]

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 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one 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. After administration of ZK 91535 skin discoloration was observed in all animals at the application site. This effect was reversible within 48 hours after treatment and most probably caused by the intensive green color of the compound.

Although the study was with respect to skin irritation / corrosion not conducted according to current guidelines and with the most sensitive species rabbit 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one 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 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 64.4 -67.6 mg) results in slight to moderate reddening and slight to severe swelling of the conjunctivae as well as slight hyperemia of the iris and slight turbidity of the cornea on administration day. On day 2 and 3 (24 and 48 h after administration) only slight irritation was found. From day 4 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, 0.17 for the iris, 0.25 for conjuntival swelling and 0.59 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.