Registration Dossier

Administrative data

Description of key information

Oral, subacute 4 weeks (Rat-Wistar, GLP, OECD TG 407): NOAEL = 1000 mg/kg
[Schering AG, Report No. AQ04 -draft-, 1997-01-30]

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Mode of Action Analysis / Human Relevance Framework

Additional information

In a subacute oral toxicity study in rats 6 -Chlor-Chlormethyldien (ZK 10882) was administered daily via gavage to 7 -6 male and 6-5 female Wistar rats per dose group, in doses of 0, 34, and 1000 mg/kg body weight for a period of 4 weeks. The animals were regularly observed and weighed. Food and water intake was determined. Ophthalmology, hematology and clinical laboratory investigations on blood samples as well as urinalysis and investigations on bone marrow and blood coagulation were performed. Organs and tissues were subjected to gross and histopathological investigations and selected organs were weighed.

Survival was not affected by treatment and no adverse effects were detected up to and including the highest dose group.

Therefore, the NOAEL in male and female rats was established to be 1000 mg/kg body weight/day.

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.