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Diss Factsheets

Administrative data

Description of key information

Oral (Rat, OECD TG 423): LD50 > 2000 mg/kg
[Schering AG, Report No. X560 -draft-, 2001-04-23]
Dermal (Rat, OECD TG 402): LD50 > 2000 mg/kg
[Schering AG, Report No. X548 -draft-, 2001-02-27]

Key value for chemical safety assessment

Additional information

The single oral administration of the test substance (ZK 4829) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality.

No compound-related clinical signs were observed and there were no macroscopic pathological signs. One male and one female animal showed a significantly reduced body weight gain.

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

The single dermal administration of the test substance (ZK 4829) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. Reddened nose was observed in all animals at 1 hour after substance administration and in one of the three male animals and in two of the three female animals at 3 hours after substance administration. All animals were without clinical findings from the second day after treatment onwards. The body weight of one male decreased between day 1 and day 8 of the study. From day 8 to day 15 body weight gain was, compared to the other male animals, only slightly lower. As all other animals did not show this effect, the significance of the finding remains unclear. No compound-related findings were observed at necropsy.

The acute dermal toxicity of Hydroxypropinol 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 1, 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.