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Administrative data

Description of key information

For a close homologue of the registered substance, one relevant (and reliable) subchronic study (90 day, rat, oral ) is available. The oral NOAEL of 250 mg/kg bw is the result of a read-across approach to the registered substance.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
250 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

The subchronic toxicity of a close homologue of the registered substance was investigated in a 90-day study similar to OECD test guideline 408. While the registered substance mainly consists of saturated components, the tested substance has a significant proportion of the corresponding unsaturated fatty alcohols. As a general rule the reactivity (and hence toxicity) is increased while the degree of saturation decreases in a molecule. Therefore, the test substance can conservatively be assumed to represent a worst case with regard to reactivity and thus to be of higher toxicity as the registered substance.

The test substance dose of 250 mg/kg bodyweight was applied orally by gavage using CMC as vehicle five times per week to Wistar rats of both sexes.

No treatment-related adverse systemic effects were observed with any parameter investigated

(clinical signs and mortality, body weight gain, haematology, biochemistry, urinanalysis and (histo-)pathology) . Therefore, the NOAEL of the test substance, and consequently the registered substance, was determined to be 250 mg/kg bodyweight/day.

Justification for classification or non-classification