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Administrative data

Description of key information

Oral (Rat, GLP, not audited report; OECD 423): LD50 > 2000 mg/kg
[Schering AG, Report X235; 1997-08-15]
Dermal (Rat, GLP, not audited report; OECD 402): LD50 > 2000 mg/kg
[Schering AG, Report X296; 1998-09-24]

Key value for chemical safety assessment

Additional information

The single oral administration of ZK 5180 to 3 male and 3 female rats at a dose of 2000 mg/kg was tolerated without compound-related clinical findings. No substance-related macroscopic pathological signs were observed. The acute oral toxicity of ZK 5180 in rats is above 2000 mg/kg body weight. [Schering AG, Report No X235; 1997 -08 -15]

The single dermal administration of ZK 5180 to 3 male and 3 female rats at a dose of 2000 mg/kg was tolerated without any compound-related clinical or macroscopic pathological signs. The acute dermal toxicity of ZK 5180 in rats is above 2000 mg/kg body weight. [Schering AG, Report X296; 1998-09-24]

Justification for classification or non-classification

Since LD50 > 2000 mg/kg after oral administration, there is no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).