Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Reproduction: The conclusion that the members of the aliphatic alcohol  category (C6to C22) are not expected to impair fertility is based on a  weight of evidence 

approach using data from reproductive screening studies [C12 (dodecanol), C18 (octadecanol)], a fertility study [C22 (docosanol)], together with a lack of effect on the 

reproductive organs in repeat dose studies over the range of linear and  essentially linear alcohols. Based on this it is concluded that octan-1-ol is not expected to impair fertility.

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, a 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. The 13-week study on 1-hexanol by (Sc. Assoc. 1966) has been used as key study also.

 


Short description of key information:
A read across feeding studies reported a lack of effects on the reproductive organs of rats receiving 1-hexanol (NOAEL 1127 mg/kg) (Scientific Associates Inc., 1966, rel; 2).

Effects on developmental toxicity

Description of key information
A reliable study using octan-1-ol (Hellwig, 1997) and performed to OECD guidelines, reported a LOAEL of 130 mg/kg bw/day (the lowest dose tested) for maternal toxicity and an NOAEL of 1300 mg/kg bw/day for teratogenicity and foetotoxicity (the highest dose tested).  In a reliable study (Nelson  et al, 1990), the NOAEC for maternal toxicity, foetotoxicity and teratogenicity in rats following inhalation exposure to 1-octanol during gestation days 1-19 was 0.4 mg/l (the highest attainable concentration).
Additional information

Developmental effects: Based on the reliable inhalation study and feeding study described above together with the weight of evidence from other alcohols across the category, it is concluded that octan-1-ol is unlikely to cause developmental effects.

Toxicity to reproduction: other studies

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 upon the above information, octan-1-ol is not required to be classified in accordance with EU guidelines.