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Description of key information

Oral (Rat, OECD TG 423): LD50 > 2000 mg/kg
[Schering AG, Report No. X549 -draft-, 2001-03-26]
Dermal (Rat, OECD TG 402): LD50 > 2000 mg/kg
[Schering AG, Report No. X525 -draft-, 2001-02-08]

Key value for chemical safety assessment

Additional information

The single oral 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 clinical signs or effects on body weight were observed and there were no macroscopic pathological signs.

The acute oral toxicity of Diketon in rats is therefore above 2000 mg/kg body weight.

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, clinical signs or findings at necropsy. The body weight of one male decreased in week 1 and this male showed a reduced body weight gain throughout the whole study period, when compared to the 90% range of historical reference data used in the study performing laboratory. As all other animals did not show any effect on the body weight, the significance of the finding remains unclear.

The acute dermal toxicity of Diketon in rats is therefore above 2000 mg/kg body weight.

Moreover, 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.

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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