Registration Dossier

Administrative data

Description of key information

A 28-day oral gavage study in rats receiving up to 1000 mg/kg bw of the test substance no clearly test substance related adverse effects were observed. The study was performed in accordance with current guidelines and under GLP. Additional neurobehavioural and neuropathological investigations were included in the study and an extended histopathology of the male sex organs was performed.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

Oral (gavage) administration of the test substance to groups of 5 male and 5 female Wistar rats with 0, 30, 300 and 1000 mg/kg bw day of test item did not result in test substance related adverse effects up to the highest dose tested. An NOAEL of 1000 mg/kg bw/day was derived from this study. Minor test substance related changes were considered of an adaptive rather than adverse nature. The study included an addtional neuorological screening battery and neurohistopathology as well as extended histopathology of the sex organs includig sperm staging. .

Justification for classification or non-classification

Based on the results of the 28 -day oral study in rats that did not reveal clearly test substance related adverse effects up to a dose level of 1000 mg/kg bw, no classification for repeated dose toxicity is warranted.