Registration Dossier

Administrative data

Description of key information

The results for repeated oral exposure are based on read across data from a dodecanol and 1-hexanol feeding study. These two studies report NOAEL values of 2000 mg/kg bw based on an OECD 422 study (Hansen 1992) for dodecanol , and 1127 mg/kg based on a 13 week oral study in the rat (Scientific Associates Inc., 1966) for 1 – hexanol.  

Key value for chemical safety assessment

Additional information

The results for repeated oral exposure are based on read across data from a dodecanol and 1-hexanol feeding study. These two studies report NOAEL values of 2000 mg/kg bw based on an OECD 422 study (Hansen 1992) for dodecanol, and 1127 mg/kg based on a 13 week oral study in the rat (Scientific Associates Inc., 1966) for 1 – hexanol. The read across repeat dose oral toxicity studies, both of which are reliability 2 will be considered as the basis for classification.

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 from 1 -dodecanol rat oral NOAEL of 2000 mg/kg bw (Hansen 1992) and 1 -hexanol rat 13 week dietary NOAEL 1127 mg/kg (Scientific Associates Inc. 1966), it is concluded that there is no basis for classification and labelling of nonanol, linear and branched.