Registration Dossier
Registration Dossier
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EC number: 276-627-0 | CAS number: 72388-18-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see Read-across justification document in chapter 13
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Reproductive effects observed:
- not specified
- Conclusions:
- In a reliable study, conducted to a protocol similar to OECD guideline 415, an NOAEL of 1000 mg/kg bw/day was determined in the rat for reproductive effects. The study was performed in compliance with GLP.
Reference
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 -dodecylhexadecan-1-ol
is not expected to impair fertility.
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see read-across justification document.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Details on test animals or test system and environmental conditions:
- According to guideline
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
- Reduction in number of live offspring:
- no effects observed
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: embryotoxicity
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: fetotoxicity
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- The structurally-related substance 2-Octyldodecan-1-ol is not cumulatively toxic to pregnant rats and does not reveal embryotoxic, fetotoxic or developmental toxic effects up to 1000 mg/kg bw, the highest dose tested.
- Executive summary:
According to an OECD 414 developmental toxicity study with the structurally-related substance 2-octyl-1-dodecanol, the test substance is not cumulatively toxic to pregnant CD rats and does not reveal embryotoxic, fetotoxic or developmental toxic effects up to 1000 mg/kg bw, the highest dose tested.
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see Read-across justification document in chapter 13
- Reason / purpose for cross-reference:
- read-across source
- Analytical verification of doses or concentrations:
- no
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- In a reliable study, conducted according to a protocol similar to OECD guideline 414, the NOAEL for maternal toxicity, teratogenicity and foetotoxicity in rabbits, was 2000 mg/kg/day (highest dose tested). The study was performed in compliance with GLP.
Referenceopen allclose all
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 -dodecylhexadecan-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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
