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Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subacute
Species:
rat

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

An oral repeated dose toxicity study (28 days, OECD TG 407) revealed no mortalities, no clinical or functional observations, no effects on body weight development and on hematological or clinico-chemical parameters.

In males liver weights were slightly increased and necropsy revealed distinct lobulation and surface changes at 1000 mg/kg. These morphological observations corresponded to centrilobular vacuolation together with eosinophilia in this group. The vacuolation was proved as hepatocellular fat deposition and might indicate an (adverse) influence on fat metabolism. Females were not affected. Gross and histopathological investigation did not give any indication of test substance-related functional or morphological alterations in the other organs examined.

The NOAEL was 300 mg/kg bw for males due to liver findings and 1000 mg/kg bw for females.

Justification for classification or non-classification

No classification required for Repeated Dose Toxicity according to Regulation (EC) No 1272/2008, Annex I.