Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
2 000 mg/kg bw/day
Additional information

Reproduction: The conclusion that the members of the aliphatic alcohol category (C6 to 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. 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. The 13-week study on 1-hexanol by (Sc. Assoc. 1966) has been used as one of the key study.

Based on this it is concluded that 1-pentadecanol is not expected to impair fertility.


Short description of key information:
Using read across data from a combined repeat dose and reproductive/developmental toxicity screening study, a lack of effects were reported on the reproductive organs of male and female rats receiving 1 -dodecanol (NOAEL > 2000 mg/kg/bw) (Hansen 1992, rel; 2). This study also reported a NOAEL for developmental effects to be 2000 mg/kg/bw.

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). No adverse effects were noted at any of the dose levels administered during the study.

Effects on developmental toxicity

Additional information

Developmental effects: Based on the weight of evidence from other alcohols across the category and the screening study with 1- dodecanol, (Hansen 1992, rel; 2) it is concluded that 1- pentadecanol is unlikely to be a developmental toxicant in the absence of maternal toxicity.

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, pentadecanol, branched and linear is not required to be classified in accordance with EU guidelines.