Registration Dossier
Registration Dossier
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EC number: 251-110-2 | CAS number: 32582-32-4
Endpoint summary
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 -tetradecyloctadecan-1-ol
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 classification of 2 -tetradecyloctadecan-1-ol
with regard to reproductive toxicity and developmental toxicity/teratogenicity.Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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