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Administrative data

Description of key information

The results for repeated oral exposure are based on read across data from a reliable 13 week oral feeding study in rats using 1-hexadecanol. This study reports a NOAEL value of > 4400 mg/kg bw. (Scientific Associates 1966a; rel 2) In addition a read across 28 day study using 1 – hexadecanol (rat, oral gavage), reported a NOAEL >1000 mg/kg bw [Henkel, 1985a; rel. 2]).
A read across from a reliable 13 week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg (Scientific Associates Inc., 1966). No adverse effects were noted at any of the dose levels administered during the study.

Key value for chemical safety assessment

Additional information

Chronic and sub-chronic toxicity studies have shown that long chain alcohols (LCA) are of low toxicity. Furthermore, combined repeated-dose studies with developmental endpoints, as well as reproductive and developmental studies showed no effects at the highest dose tested.

Rather than having separate values for the three endpoints, one endpoint “systemic effects” has been used instead. Since the NOAELs do not vary greatly across the category, one key study has been chosen as being representative of the whole category.

 

C6, Hexanol has been chosen as the category representative because shorter chain molecules are usually regarded as more toxic when compared to structural analogues with longer carbon chain lengths.

 

Justification for classification or non-classification

Based on the read across data from the 13 week rat oral feeding study using 1- hexadecanol (NOAEL > 4400 mg/kg/bw/d, Scientific Associates 1966a; rel 2) and the absence of any repeat dose study treatment related effects from other alcohols within the category, it is concluded that there is no basis for classification and labelling of pentadecanol, branched and linear.

Based on the NOAEL of 1127 mg/kg, no EU classification will be required.