Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

In addition to the 13 week read across feeding study in rats which reported a NOAEL of 1127 mg/kg (Scientific Associates Inc, 1966; rel2), read across from a combined repeat dose/reproductive/developmental toxicity screening study with 1 -dodecanol reported a NOAEL 2000 mg/kg. (Hansen 1992, rel; 2).

 

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. It is therefore concluded that decanol ¿ branched and linear, 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, 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.


Short description of key information:
A read across 13 week feeding study reported a lack of effects on the reproductive organs of rats receiving 1 -hexanol (NOAEL 1127 mg/kg) (Scientific Associates Inc., 1966, rel; 2)

A reliable read across rat oral developmental toxicity study using ethyl hexanol reported a NOAEL of 130 mg/kg/day for both maternal and developmental toxicity. (Hellwig, 1997; rel. 2)

Effects on developmental toxicity

Additional information

A developmental toxicity key study in rats by whole body inhalation exposure to 1 ¿decanol over 19 days, reported a developmental and maternal NOAEC of 0.1 mg/l, which was the highest dose tested. (Nelson, 1990, rel 2). Based on these studies and evidence from across the category, it is concluded that decanol- branched and linear, is unlikely to cause developmental effects.

Justification for classification or non-classification

Based upon the above information decanol ¿ branched and linear does not require classification for this endpoint.