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EC number: 267-008-6 | CAS number: 67762-27-0 This substance is identified by SDA Substance Name: C16-C18 alkyl alcohol and SDA Reporting Number: 19-060-00.
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Alcohols, C16-18 is a member and is from Long Chain Alcohols (C6-22 primary aliphatic alcohols) category.
The Long Chain Alcohols (C6-22 primary aliphatic alcohols) category is considered suitable as a source of data for Alcohols, C16-18.
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified.
Long Chain Alcohols (C6-22 primary aliphatic alcohols) category covers a family of 30 primary aliphatic alcohols within a carbon chain length range of C6-C22. Commercial products generally include several aliphatic alcohol components, with a range of carbon chain lengths present. The family consists of alcohols with varying compositions and structures. Composition depends on the route to manufacture and the related feedstocks. Most of the alcohols have linear carbon chains but certain manufacturing processes create branched structures. Data are also available for eleven other similar substances, which support the category. Non-sponsored alcohols may not be HPV or may not be produced by members of the consortium, but have structures similar to sponsored linear alcohols.
Key points are that the members share:
• The same structural features
• Similar metabolic pathways
• Common mode of ecotoxicological action
• Common levels and mode of human health related effects.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 022
- Reference Type:
- publication
- Title:
- Dossier on 1-Octadecanol.
- Author:
- Hachiya N, Takeya A, Takizawa Y
- Year:
- 1 982
- Bibliographic source:
- Japanese J. Public Health 29(5): 236-239. (In Japanese, translation available)
- Reference Type:
- publication
- Title:
- SIDS Dossier on 1-Octadecanol.
- Author:
- Environmental Protection Agency,
- Year:
- 1 993
- Bibliographic source:
- Environmental Protection Agency, Denmark. 6 June 1993.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- Method: other: mouse bone marrow micronucleus test to protocol to the Japanese Labour Ministry
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Octadecan-1-ol
- EC Number:
- 204-017-6
- EC Name:
- Octadecan-1-ol
- Cas Number:
- 112-92-5
- Molecular formula:
- C18H38O
- IUPAC Name:
- octadecan-1-ol
- Details on test material:
- Octadecanol (112-92-5) (Kalcohol 80, 718)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: ddY
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS: Mice
- Age: 6 weeks
- Weight at study initiation: not reported
- No. of animals per dose: Groups of 5 or 6
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Vehicle used: olive oil
- Details on exposure:
- ADMINISTRATION: Gavage
- Vehicle: Olive oil, dosing volume 25 ml/kg
- Duration of test: 1 or 4 doses.
- Frequency of treatment: Once or 4 times in 24 hours.
- Sampling times and number of samples: 24 hours after a single does, 5 days after the first administraton of the repeated doses. 2000 red blood cells scored per smear for micronuclei, 1000 scored for reticulocytes.
- Control groups and treatment: Stearyl alcohol single oral doses of 0.36, 0.73 or 1.45 g/kg/day or 4 doses of 0.73 g/kg/day in a 24 hour period. Positive control mitomycin C 3 mg/kg intraperitoneally. Solvent control olive oil 25 ml/kg - Duration of treatment / exposure:
- 24 hours
- Frequency of treatment:
- single administration and 4 administrations
- Post exposure period:
- 24 hours (single administration); 5 days from initial administration (repeat administration)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
360, 730, 1450 mg/kg (single dose) or 730 mg/kg (adminstered 4 times in 24 hours)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 6 (single dose) 5 (repeat dose) sex not stated
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Positive control: mitomycin C
- Route of administration: ip injection
- Doses / concentrations: 3.0 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrrow; erythrocytes examined
- Statistics:
- STATISTICAL ANALYSIS: Kastenbaum & Bowman
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- MORTALITY: Not reported
CLINICAL SIGNS: Not reported
NECROPSY FINDINGS: Not reported
BODY WEIGHT CHANGES: Not reported
FOOD AND WATER CONSUMPTION CHANGES: Not reported
EFFECT ON MITOTIC INDEX OR PCE/NCE RATIO: There were no effects on the incidence of reticulocytes following a single dose of stearyl alcohol.
Repeated exposure showed a decrease [controls 61.3%; treated 52.9%]
GENOTOXIC EFFECTS: No significant increase increase in numbers (%) of micronucleated erythrocytes. 10000 - 12000 observed.
NOAEL (NOEL) (C) / LOAEL (LOEL) (C): A single dose of 1450 mg/kg/day or a total repeated dose of 2920 mg/kg did not increase the incidence of
micronuclei. There was no reported assessment of effects on the live animals.
Any other information on results incl. tables
Results of micronucleus assay
Treatment |
Vehicle 25 ml/kg |
Positive control 3.0 mg/kg |
Low dose |
Mid dose |
High dose |
Mid dose |
No of injections |
1 |
1 |
1 |
1 |
1 |
4 |
Micronucleated erythrocytes % |
0.13 ±0.10 |
1.96 ± 0.64 |
0.03 ± 0.03 |
0.06 ± 0/04 |
0.09 ± 0.04 |
0.08 ± 0.08 |
Frequency of erythrocytes |
81.3 ± 8.0 |
46.2 ± 9.4 |
61.5 ± 6.2 |
60.3 ± 9.2 |
67.4 ± 7.5 |
52.9 ± 7.6 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results : negative
Stearyl alcohol (Kalcohl 80, 718) did not increase the incidence of micronucleated cells in mouse bone marrow erythrocytes following a single oral dose level up to and including 1450 mg/kg or a total of 2920 mg/kg adminstered as 4 doses in a 24 hour period. It is concluded that the test substance is negative for induction of micronuclei under the conditions of the test.
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