Registration Dossier

Diss Factsheets

Administrative data

Description of key information

A high quality, guideline- and GLP-compliant 28-day oral rat study is available.

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
Quality of whole database:
A high quality, guideline- and GLP-compliant 28-day rat study is available. A waiver is proposed for the 90-day study in the absence of any effects in the 28-day study and as systemic exposure is unlikely.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
No study is available.

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
No study is available.

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
No study is available.

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
No study is available.

Additional information

No effects of treatment were observed in a 28 -day oral (gavage) rat study at the limit dose of 1000 mg/kg bw/d. A waiver is proposed for the 90-day study in the absence of any effects in the 28-day study and as systemic exposure is unlikely.

Justification for classification or non-classification

The substance is of very low toxicity following repeated oral exposure; the available data do not warrant classification for STOT-RE under the CLP Regulation.