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EC number: 204-017-6 | CAS number: 112-92-5
- 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 vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- without detailed documentation
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- The toxicity of behenyl alcohol: I. Genotoxicity and subchronic toxicity in rats and dogs
- Author:
- Iglesias G, J J Hlywka, J E Berg, M H Khalil, L E Pope and D Tamarkin
- Year:
- 2 002
- Bibliographic source:
- Regulatory Tox. and Pharm. 36, 69-79, 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Well-conducted study according to protocol very similar to OECD guideline 473
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Docosan-1-ol
- EC Number:
- 211-546-6
- EC Name:
- Docosan-1-ol
- Cas Number:
- 661-19-8
- Molecular formula:
- C22H46O
- IUPAC Name:
- docosan-1-ol
- Test material form:
- other: Waxy Solid
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: minimum essential medium
- Properly maintained: no data
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver microsomal fraction from male rats prepared according to Ames et al., 1977
- Test concentrations with justification for top dose:
- 0.6, 10.0 and 20.0 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: solubility
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- ethylmethanesulphonate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: not applicable
- Exposure duration: 4 hours
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): 7 and 24 (or 28) hours at 20 µg/ml, 18 hours at 0.6, 10 and 20 µg/ml
SPINDLE INHIBITOR (cytogenetic assays): Colcemid, 0.2 µg/ml
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2 cultures per concentration
NUMBER OF CELLS EVALUATED: 100 per slide, 200 per concentration
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
- Evaluation criteria:
- To be considered positive, either a statistically significant, concentration-related increase in the number of structural chromosome aberrations, or a statistically significant positive response at one of the concentrations
- Statistics:
- Chi-squared test performed for cells with aberration (excluding gaps)
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: presumably >20 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: insoluble
- Precipitation: no data
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES: yes, but no data presented
COMPARISON WITH HISTORICAL CONTROL DATA: no data
ADDITIONAL INFORMATION ON CYTOTOXICITY: at 20 µg/ml, mitotic index not reduced, plating efficiency not reduced - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table 1 Cytogenicity: 7 hour fixation. Aberrations in 200 cells
Activation |
Concentration µg/ml |
Percent aberrant cells |
||
incl gaps |
excl gaps |
exchanges |
||
Without |
0* |
4.0 |
1.5 |
0 |
20 |
2.5 |
0.5 |
0 |
|
With |
0* |
4.0 |
1.5 |
0 |
20 |
7.0 |
2.5 |
0 |
* Solvent control with ethanol
** Only 100 cells counted for positive controls
Table 2 Cytogenicity: 18 hour fixation. Aberrations in 200 cells
Activation |
Concentration µg/ml |
Percent aberrant cells |
||
incl gaps |
excl gaps |
exchanges |
||
Without |
Negative control |
5.5 |
1.5 |
0 |
0* |
4.0 |
1.5 |
0.5 |
|
0.6 |
4.5 |
2.0 |
0 |
|
10 |
4.0 |
1.0 |
0.5 |
|
20 |
3.0 |
0.5 |
0 |
|
Positive control** |
12.0 |
9.0 |
4.0 |
|
With |
Negative control |
2.5 |
1.5 |
0 |
0* |
2.5 |
1.5 |
0.5 |
|
0.6 |
5.5 |
3.0 |
0.5 |
|
10 |
4.0 |
2.5 |
0 |
|
20 |
4.0 |
2.5 |
0.5 |
|
Positive control** |
16.0 |
13.0 |
5.5 |
* Solvent control with ethanol
** Only 100 cells counted for positive controls
Table 3 Cytogenicity: 18 hour fixation. Aberrations in 200 cells
Activation |
Concentration µg/ml |
Percent aberrant cells |
||
incl gaps |
excl gaps |
exchanges |
||
Without |
0* |
6.0 |
2.5 |
0.5 |
20 |
3.5 |
2.0 |
0 |
|
With |
0* |
1.0 |
0.5 |
0 |
20 |
4.0 |
2.5 |
0.5 |
* Solvent control with ethanol
** Only 100 cells counted for positive controls
Applicant's summary and conclusion
- Conclusions:
- In a reliable study, according to a protocol that is similar to OECD 473, behenyl alcohol (C22) did not increase the incidence of chromosome aberrations in Chinese hamster V79 cells in the presence or absence of metabolising fraction at concentrations up to 20 µg/ml. There was no evidence of cytotoxicity at this dose level.
- Executive summary:
In an in vitro chromosome aberration study, Chinese hamster lung fibroblasts (V79) were incubated with 0.6, 10.0 and 20.0 µg/ml of test material dissolved in ethanol for 4 hours, with and without metabolic activation.
The test substance did not increase the incidence of chromosome aberrations in Chinese hamster V79 cells in the presence or absence of metabolic activation when tested up to limit concentration. There was no evidence of cytotoxicity at this dose level. The study was comparable to guideline without detailed documentation (publication). It is considered that read across to the registered substance is valid and scientifically justifiable.
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