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EC number: 464-320-6 | CAS number: 423772-95-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- August to November 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-octyldodecan-1-ol
- EC Number:
- 226-242-9
- EC Name:
- 2-octyldodecan-1-ol
- Cas Number:
- 5333-42-6
- Molecular formula:
- C20H42O
- IUPAC Name:
- 2-Octyldodecan-1-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- According to guidelineTEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 8-10 weeks
- Weight at study initiation: mean weight 196 g
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 38-58
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: September 30 to November 4, 1992
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on exposure:
- Test substance was administered orally by gavage once daily in the morning from day 6 up tp day 15 post coitum inclusive. All groups received a dose volume of 5ml/kg body weight, adjusted to the body weight of day 6 post coitum. Control animals were similarly dosed with the vehicle alone.
- 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.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Group 1 (Control group)
- Dose / conc.:
- 100 mg/kg bw/day
- Remarks:
- Group 2 (Low dose, actual ingested)
- Dose / conc.:
- 300 mg/kg bw/day
- Remarks:
- Group 3 (Mid dose, actual ingested)
- Dose / conc.:
- 1 000 mg/kg bw/day
- Remarks:
- Group 4 (High dose, actual ingested)
- No. of animals per sex per dose:
- 24
- Control animals:
- yes
- Details on study design:
- none
Examinations
- 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
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
Maternal developmental toxicity
- 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:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- other: No maternal toxicity was observed at all tested doses.
Maternal abnormalities
- Key result
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Group 1: no variations
Group 2: ribs rudimentary unilateral/bilateral, significant decrease at level 1%, thoracic vertebrae, dumbbell shape, significant increase at level 5%
Group 3: no variations
Group 4: thoratic vertebrae, dumbell shape, significant increase at level 1%
The statistical significant differences were considered to be incidental. The findings in the ribs rudimentare are due to the increase of the control group. The other variation effects to the thoratic vertebrae, dumbell shape are also incidental and not dose-related. The incidental character of these variations is emphasized by the fact that the values were within the normal range of variations for this strain. - Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: embryotoxicity
- Remarks on result:
- other: No effects were observed at all tested doses.
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: fetotoxicity
- Remarks on result:
- other: No effects were observed at all tested doses.
Fetal abnormalities
- Key result
- Abnormalities:
- not specified
Overall developmental toxicity
- Key result
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the NOAEL for maternal systemic toxicity and developmental toxicity was up to 1000 mg /kg bw/day, as no effects were observed at all tested doses.
- Executive summary:
In a developmental toxicity study conducted according to the OECD guideline No. 414 and in compliance with GLP, 2 -octyl-1 -dodecanol diluted in arachis oil was administered to 24 females rats/dose by gavage at dose levels of 0, 100, 300 or 1000 mg/kg bw/day from days 6 through 15 of gestation.
All animals were observed twice daily for appearance and behavior. The uteri and ovaries were examined, and the number of fetuses, early and late resorptions, total implantations and corpora lutea were recorded. Gravid uterine weights were recorded, and net body weights and net body weight changes were calculated. The fetuses were weighted, sexed and examined for external, visceral and skeletal malformations and developmental variation.
All animals survived to the scheduled necropsy. No maternal effects were observed in all tested doses.
There were no test article-related internal findings at the scheduled necropsy. For the effect on fetuses, no significant changes were observed in the number of live fetuses, embryo/fetal mortality, sex ratio, body weight of live fetuses, or in the external, visceral, or skeletal examination of fetuses, at all tested animals. No test article-related fetal malformations or developmental variations were noted at any dose level in this study. No other signs of developmental toxicity were noted.
Based on the results of this study, the dose level up to 1000 mg/kg bw/day was considered to be the NOAEL(systemic effects) for maternal toxicity and the NOAEL for developmental toxicity.
Under the test conditions, the test substanceis not classified according to Regulation (EC) No.1272/2008 (CLP) criteria.
This study is acceptable and satisfies the requirement for developmental toxicity endpoint.
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