Registration Dossier

Administrative data

Description of key information

The no-observable-effect-level (NOEL) of the test substance in dogs via capsule administration for a period of 3 months was determined to be 2000 mg/kg/day.

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
Study duration:
subchronic
Species:
dog

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

Mode of Action Analysis / Human Relevance Framework

Additional information

After 3 months of treatment, selected organ/body weight and organ/brain weight ratios were calculated. Complete gross post mortem examinations and histopathological valuation of selected tissues were conducted on all animals. None of the parameters, including mortality, physical observations, body weights and food consumption, hematology, clinical chemistry, ophthalmology, urinalysis, organ weight data and macroscopic and microscopic examination revealed any indication of adverse effects due to administration of the test substance.

Justification for classification or non-classification

No significant toxic effects of relevance to human health were observed at any of the dose concentrations used in a 90 -day repeat dose study on the dog.