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EC number: 310-080-1 | CAS number: 102242-49-9 The complex residue resulting from the vacuum distillation of C6-24 fatty alcohols which is derived from hydrogenation of C6-24 fatty acids methyl esters. It consists predominantly of satd. fatty alcohols having carbon numbers greater than C18, dimerization products, and long chain esters having carbon numbers greater than C32 and boils at > 250°C (482°F) at 10 torr.
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD test guideline 422 under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 112-95-5
- IUPAC Name:
- 112-95-5
- Details on test material:
- - Name of test material (as cited in study report): 1-Octadecanol
- Molecular formula (if other than submission substance): C18H38O
- Analytical purity: 99% (Sigma L 5751)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mollegard breeding center, Denmark
- Age at study initiation: females: 7 weeks; males: 8 weeks
- Housing: The rats were kept in steel wire cages type 3 until day 20 in
pregnancy where the pregnant female were placed in macroIon cages type 3.
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C.
- Humidity (%): 55 ± 10%.
- Photoperiod (hrs dark / hrs light): Fluorescent light was on from 20 pm. to 8 am.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: IT CHOW 101
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): once
- Mixing appropriate amounts with (Type of food):
BARLEY 6,060 KG
MINERALMIXTURE 0,660 KG
VITAMINS B-K 0,240 KG
1-0CTADECANOL 0,600 KG
SKIM MILK POWDER 6,540 KG
OATS 5,400 KG
SOIA BEAN OIL,cc A.D.E. VIT. 0,500 KG
VEHICLE
- Justification for use and choice of vehicle (if other than water): feed, as the substance is well digestable
- Concentration in vehicle: 3% - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- After a 14 days dosing period the females were placed together with the males, 1 to
1. Check for mating included inspection for plugs during the morning, at lunch time and
dUring the afternoon. The day on which a plug was recorded at lunch time or during
the afternoon was defined day O. The day on which a plug was recorded during the
morning was defined day 1 in pregnancy. Females, in which no mating was recorded,
were kept together with the same male for a 14 days period. If no plug and no
indication on pregnancy was found after a 14 days period, the female rat was placed
together with an other male for an 8 days period. - Duration of treatment / exposure:
- females: 14 days
males: 45 days - Frequency of treatment:
- daily by diet
- Duration of test:
- females: 14 treatment before mating; mating for up to 22 days; termination 5 days after birth
males: 45 day
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg bw
Basis:
actual ingested
calculated from food consumption
- Remarks:
- Doses / Concentrations:
500 mg/kg bw
Basis:
actual ingested
calculated from food consumption
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw
Basis:
other: calculated from food consumption
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, plain diet
- Details on study design:
- 2000 mg/kg bw
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- 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: No
- Skeletal examinations: No
- Head examinations: Yes
- Malformations of internal organs
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a study according to OECD test guideline 422, the NOAEL of 1-Octadecanol for reproductive/developmental toxicity was determined to be 2000 mg/kg bw.
- Executive summary:
The reproductive/developmental toxicity of 1-octadecanol was determined in a study according to OECD test guideline 422 under GLP.
The substance was administered to rats in doses of 0, 100, 500, and 2000 mg/kg bw/day via the diet over 14 days.
Developmental parameters examined were external and head examinations, as well as organ formations.
No indication for effects of the test substance on any of these parameters were found. Consequently, the NOAEL of 1-Octadecanol for reproductive/developmental toxicity was determined to be 2000 mg/kg bw.
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