Registration Dossier

Administrative data

Description of key information

Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg
[Schering AG, Report No. X325 -draft-, 1998-11-05]
Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg
[Schering AG, Report No. X323 -draft-, 1998-11-05]

Key value for chemical safety assessment

Additional information

The single oral administration of the test substance (ZK 34517) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. One male animal showed ruffled fur and atactic gait on the first day after administration of ZK 34517. The other animals were without findings over the whole study period. No compound-related findings were observed in body weight gain. At autopsy a diminished size of seminal vesicles were seen in the male animals. The acute oral toxicity of Dimethylenketon in rats is therefore above 2000 mg/kg body weight.

The single dermal administration of the test substance (ZK 34517) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The acute dermal toxicity of Dimethylenketon in rats is therefore above 2000 mg/kg body weight.

No local intolerance reactions at the application sites were observed.

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.