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EC number: 278-306-0 | CAS number: 75782-86-4
- 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)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. Read across to the registered substance is considered scientifically justified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Alcohols, C10-16
- EC Number:
- 267-019-6
- EC Name:
- Alcohols, C10-16
- Cas Number:
- 67762-41-8
- IUPAC Name:
- tetradecan-1-ol
- Details on test material:
- - Name of test material (as cited in study report):
Sasol(TM) 23 Alcohol C10-16 alcohols Type B (also known as Compound 33A). Equivalent to Alcohols, C12-13-branched and linear (CAS 75782-86-4)
- Substance type: UVCB substance
- Physical state: liquid
- Lot number: KPT/SAS/DA/2/98
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- Test 1: 0.1 - 500 µg/ml; Test 2: with S9 1 -50 µg/ml, without S9 0.5 - 20 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: none given in report. Standard solvent
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with activation
- Details on test system and experimental conditions:
- ACTIVATION: 1 ml Aroclor induced rat liver S9 mix, NADP as cofactor
METHOD OF APPLICATION: in medium
DURATION
Exposure duration: Test 1: +S9 3 hours, -S9 18 hours, Test 2: +S9 3 hours; -S9 18 or 32 hours
- Expression time (cells in growth medium): 18 hours
- Fixation time (start of exposure up to fixation or harvest of cells): Test 1 18 hours; Test 2 18 or 32 hours
SPINDLE INHIBITOR (cytogenetic assays): Colcemid (final concentration 0.1 mM)
TAIN (for cytogenetic assays): Giesma
NUMBER OF REPLICATIONS: Duplicate cultures, independent repeat assay
NUMBER OF CELLS EVALUATED: 100 per culture
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; other: observation of culture
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes
- Other: interstitial deletions - Evaluation criteria:
- CRITERIA FOR EVALUATING RESULTS: The test is considered positive if the aberration frequency of at least one concentration is significantly above concurrent control frequencies.
- Statistics:
- Fisher's exact probability test (two-sided)
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- +S9 40 µg/ml; -S9 15 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- GENOTOXIC EFFECTS: - With and without metabolic activation:
There were no statistically significant increase in total numbers of chromosome aberrations at any dose level tested
There was no increase in the incidence of polyploids or endoreduplicates.
PRECIPITATION CONCENTRATION: 125 µg/ml.
MITOTIC INDEX: The mitotic index was measured on 1000 cells and was always >40% of control levels and usually >50% for the dose levels which were scored for chromosome aberrations.
STATISTICAL RESULTS: Fischers exact probability test (two-sided) did not indicate any significant difference between test and control groups. - Remarks on result:
- other: strain/cell type: Chinese hamster ovary cells (CHO K-1 line)
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Chromosome aberration assay: Test 1
Treatment time 18 hrs |
||||||
Treatment |
Activation |
Concentration µg/ml |
Number of cells |
Total - gaps |
Total + gaps |
|
Negative control DMSO |
-MA |
0 |
200 |
0 |
4 |
|
Test substance
|
-MA |
2.5 |
200 |
0 |
6 |
|
-MA |
5 |
200 |
0 |
6 |
||
-MA |
10 |
200 |
2 |
8 |
||
Positive control Mitomycin C |
-MA |
0.025 |
200 |
48 |
48 |
|
Treatment time 3 hrs |
||||||
Treatment |
Concentration µg /ml |
Number of cells |
Total - gaps |
Total + gaps |
||
Negative control DMSO |
+MA |
0 |
200 |
0 |
2 |
|
Test substance
|
+MA |
10 |
200 |
1 |
6 |
|
+MA |
20 |
200 |
1 |
5 |
||
+MA |
30 |
200 |
1 |
5 |
||
Positive control Cyclophosphamide |
+MA |
3.75 |
200 |
48 |
48 |
Chromosome aberration assay: Test 2
Treatment |
-MA |
Concentration µg /ml |
Number of cells |
Total - gaps |
Total + gaps |
Treatment time 18 hrs |
|||||
Negative control DMSO |
-MA |
0 |
200 |
1 |
5 |
Test substance
|
-MA |
5 |
200 |
2 |
8 |
-MA |
7.5 |
200 |
0 |
5 |
|
-MA |
10 |
200 |
1 |
4 |
|
Positive control Mitomycin C |
-MA |
0.025 |
200 |
54 |
54 |
Treatment time 3 hrs, incubation 18 hours |
|||||
Treatment |
Concentration µg /ml |
Number of cells |
Total - gaps |
Total + gaps |
|
Negative control DMSO |
+MA |
0 |
200 |
0 |
8 |
Test substance
|
+MA |
10 |
200 |
1 |
2 |
+MA |
20 |
200 |
1 |
7 |
|
+MA |
30 |
200 |
1 |
7 |
|
Positive control Cyclophosphamide |
+MA |
3.75 |
200 |
105 |
105 |
Treatment time 32 hrs |
|||||
Treatment |
Concentration µg /ml |
Number of cells |
Total - gaps |
Total + gaps |
|
Negative control DMSO |
-MA |
0 |
200 |
0 |
8 |
Test substance |
-MA |
10 |
200 |
0 |
7 |
Treatment time 3 hrs, incubation 32 hours |
|||||
Treatment |
Concentration µg /ml |
Number of cells |
Total - gaps |
Total + gaps |
|
Negative control DMSO |
+MA |
0 |
200 |
2 |
3 |
Test substance |
+MA |
30 |
200 |
0 |
5 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without activation
C12 AND 13 ALCOHOLS; LINEAR AND MONOBRANCHED, TYPE 2 (also known as Compound 33A) has been tested in a valid study according to OECD TG 473 and under GLP in CHO K1 cells. The test substance did not increase the incidence of chromosome aberrations in Chinese hamster ovary cells at dose levels up to cytotoxic concentrations in the presence or absence of metabolic activation. The result of the repeat experiment confirmed that of the initial assay. It is concluded that the test substance is negative for the induction of chromosome aberrations under the conditions of this test.
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.
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