Registration Dossier

Administrative data

Description of key information

A 90-day repeated dose oral toxicity study is available for the submission substance.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
275 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
A modern, guideline- and GLP-compliant 90-day rat study is available for the submission substance.

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

A 90 -day repeated dose oral toxicity study performed with the submission substance (Longobardi, 2017) reports a NOAEL of 275 mg/kg bw/d, based on findings (mortality, clinical signs, changes in haematology and clinical chemistry parameters and increased liver weight at the highest dose level of 750 mg/kg bw/d. A slight reversible increase in liver weight without pathological correlates and minor fluctuations in clinical chemistry parameters seen at 275 mg/kg bw/d were not considered to represent an adverse effect.

Justification for classification or non-classification

No classification is proposed: relevant data are not available