Registration Dossier

Administrative data

Description of key information

Oral (Rat, GLP): LD50 > 2000 mg/kg
[Schering AG, Report No. A860, 1994-01-12]
Dermal (Rat, GLP): LD50 > 2000 mg/kg
[Schering AG, Report No. X192, 1997-01-08]

Key value for chemical safety assessment

Additional information

The single oral administration of the test substance (ZK 39211) to male and female rats at a dose of 2000 mg/kg was tolerated without any compound-related clinical or macroscopic pathological signs. The acute oral toxicity of ZK 39211 in rats is above 2000 mg/kg body weight. (Schering AG, Report No. A860, 1994-01-12)

The single dermal administration of Tamip monoamide to male and female rats in the doses of 200 and 2000 mg/kg results at high dose in clinical signs (retarded respiration, gasping breathing, eyelid closure, unconsciousness in 1/3 male rats; apathy 2/3 male rats). One male rat died. The female animals were without any clinical signs. LD50 > 2000 mg/kg (Schering AG, Report No. X192, 1997-01-08)

Justification for classification or non-classification

For oral and dermal administration classification according to Directive 67/548/EEC and Regulation 1272/2008/EC is not required since LD50 <2000 mg/kg.