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Diss Factsheets
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EC number: 226-242-9 | CAS number: 5333-42-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Sex:
- male/female
- 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
- Sexual maturation:
- not examined
- Gross pathological findings:
- no effects observed
- 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-octyldodecanol is not expected to impair fertility.
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August to November 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- According to guideline
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on exposure:
- Test substance is stable in arachidis oil.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- According to guideline.
- Duration of treatment / exposure:
- day 6 to day 15 of gestation.
- Frequency of treatment:
- daily
- Duration of test:
- until day 20 of gestation.
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 24
- Control animals:
- yes
- Details on study design:
- none
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
POST-MORTEM EXAMINATIONS: Yes - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes :
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: half per litter - Statistics:
- yes
- Historical control data:
- no
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined - Changes in number of pregnant:
- no effects observed
- 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
- Fetal body weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The mean weight of live male fetuses was decreased in low dose group (level 5 %): due to the lack of a dose response the effect was considered to be not treatment-related.
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not examined - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not examined
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- one fetus with paleness (not considered to be treatment-related)
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Control (131 examined fetuses):
28 hydronephrosis
14 urether waved
1 ureter dilatation
Low dose group (100 mg/kg) (142 examined):
29 hydronephrosis
12 urether waved
9 ureter dilatation
Mid dose group (300 mg/kg) (142 examined):
39 hydronephrosis
14 urether waved
10 ureter dilatation
HIgh dose group (1000 mg/kg) (133 examined):
33 hydronephrosis
13 urether waved
14 ureter dilatation
1 ear region severe subcutaneous hematoma [artifact] - Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
- 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:
- 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 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
- 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.
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study without detailed documentation (publication).
- Principles of method if other than guideline:
- Method: other
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Sprague-Dawley
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- For 15 days prior to mating, during mating and up to Day 17 of gestation.
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
10, 100, 1000 mg/kg bw
Basis: - Control animals:
- yes
- Details on study design:
- Sex: female
Duration of test: 20th day of gestation - Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- 1000 mg/kg/day is the NOAEL for maternal toxicity, teratogenicity and foetotoxicity in rats receiving behenyl alcohol by gavage for 15 days premating, during mating and up until gestation day 17. This is based on the absence of adverse effects in any of the parental, reproductive or foetal parameters examined.
Referenceopen allclose all
All female rats survived to sacrifice and no maternal toxicity was observed. The were no differences between treated and control animals in any of the rerpoductive endpoints investigated (corpora lutea, pre & post implantation sites, early & late resorption sites). The litter size, foetal weight and sex ratio observed in treated groups was comparable to the control group. There were no unusual macroscopic findings among foetuses. Microscopic examination did not show any increased incidence of anomalies in skeletal or soft tissues. See above chapter 5.8.1 for further details.
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 (2000 mg/kg bw/d) were 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-octyldodecan-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.
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