Registration Dossier

Diss Factsheets

Administrative data

Description of key information

A subchronic oral toxicity study, dosed via feed at concentrations of 10, 40 and 160 mg/kg bw/day, has revealed few effects that can be definitely attributed to treatment. The liver- and kidney-weight increases are considered to be treatment-related, although it is uncertain whether these were toxic or adaptive effects. Hence, clear adverse effects were not identified in this study and the authors, on this basis, have set the no-effect level (NOEL) for this study to 10 mg/kg/day.

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
subchronic
Experimental exposure time per week (hours/week):
13
Species:
rat
Organ:
kidney
liver

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In lack of clear adverse effects ina subchronic toxicity study via feed, a classification according to CLP (Regulation EC No 127272008) for STOT repeat exposure is not required.