Registration Dossier

Diss Factsheets

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, TG OECD 402): not skin irritating
[Schering AG, Report No. X525 -draft-, 2001-02-08]
Eye irritation (Rabbit, GLP, OECD TG 405): not eye irritating
[Schering AG, Report No. X584 -draft-, 2002-01-09]

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 233744) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. No compound-related local findings were observed. The mean values of findings at the time-points 24, 48 and 72 h after administration were 0 for swelling, reddening and scab formation. 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 Diketon 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 Diketon into the right eye of 2 (3) males and 2 female rabbits with a volume of 0.1 ml/eye (corresponding to 61.5 -65.2 mg) resulted in slight reddening of the conjunctivae observed in all animals on the administration day and on days 2 and 3 (except one female animal only until day 2). Slight to moderate swelling of the conjunctivae was observed in two male animals and one female animaion the administration day. In one female animal slight swelling was seen until day 3. All animals were without findings on day 4.

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, 0.17 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.

Categories Display