Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A well documented one-generation study of the structurally-related linear alcohol 1-docosanol in rat is available which was performed according to a protocol similar to OECD 415. There were no treatment related effects on reproductive parameters observed

Furthermore in the repeated dose toxicity studies with 2-octyldodcan-1-ol and 1-docosanol no effects on reproductive organs could be found.

Based on these data it is concluded that 2-hexyldecanol is not expected to impair fertility.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

A well documented OECD 414 developmental toxicity study in rats is available for 2-octyldodecan-1-ol (C20). The substance is not cumulatively toxic to pregnant rats and does not reveal embryotoxic, fetotoxic or developmental effects up to the highest dose tested (1000 mg/kg bw/d).

In a one.generation study with the structurally-related linear C22 alcohol docosan-1-ol rats received the substance by gavage for 15 days premating, during mating and up until gestation day 17. No adverse effects in any of the parental, reproductive or foetal parameters were observed.

Furthermore a published well-documented developmental toxicty study in rabbits on the structurally-related linear alcohol 1-docosanol is available. In the study no substance-related maternal and developmental toxicity up to the highest dose tested (to 2000 mg/kg bw/d) was observed.

Due to their structural similarity no developmental toxicity is expected for the whole category of Guerbet alcohols.

Justification for classification or non-classification

Available data are conclusive but not sufficient for classfication of 2-hexyldecan-1-ol with regard to reproductive toxicity and developmental toxicity/teratogenicity.