Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

No acute toxicity studies were conducted with ZK 5145; read across approach with results of studies with androstanolone acetate (ZK 5180, CAS 1164-92-7):
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

No acute toxicity studies were conducted with ZK 5145 (androstonolone). Results of one study conducted with an ester of androstonolone (androstonolone acetate, ZK 5180) are regarded as representative as most likely ester cleavage occurs in vivo after administration.

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).