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Administrative data

Description of key information

In the key combined repeated dose with the reproduction/developmental toxicity screening test in rats (OECD 422), the No Observed Adverse Effect Level (NOAEL) for Ethyl caproate as a Read across substance was up to 1000 mg/kg bw/day (top dose).

In consideration of the molecular weight of both substances (144.21 and 102.13 g/mol) No-Observed-Adverse-Effect-Levels (NOAELs) for general toxicity effects and reproduction/developmental toxicity are considered to be at least 708 mg/kg/day.

Using this read across approach, the target substance was not to be classified for long term toxicity endpoints according to CLP.

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
708 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The key source study was a good quality study, conducted using OECD Guideline 422 and complies with GLP and was therefore assigned 1 (reliable without restrictions). However, these data have been scored as reliability 2 (reliable with restrictions) when used for read across to the target test 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

Mode of Action Analysis / Human Relevance Framework

Additional information

In the key source study, a test item-related increase in thyroid hormone (T4) was observed in adult males and pups at 1000 mg/kg. However, it was not considered to have toxicological relevance since there were no correlated changes in other parameters including microscopic findings of thyroids (with parathyroids). At the top dose an increase in prothrombin time (both sexes) and increased kidney weight (females) was observed; however, these effects were not considered to be toxicologically relevant as no correlated microscopic findings were observed. Additionally, decreased gamma glutamyl transpeptidase was identified in males in all test item-treated groups; however, it was not considered to have toxicological relevance since there were no correlated microscopic findings.

Justification for classification or non-classification

No adverse effects were observed in the key combined repeated dose with the reproduction/developmental toxicity screening test (OECD 422) in rats for ethyl caproate as a read-across substance; therefore, the test substance is not classificable as STOT RE according to CLP (Regulation EC No 1272/2008).