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EC number: 298-361-4 | CAS number: 93803-87-3
- 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://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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
- Study period:
- 10 Feb-28 Mar 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2-octyldodecyl isooctadecanoate
- EC Number:
- 298-361-4
- EC Name:
- 2-octyldodecyl isooctadecanoate
- Cas Number:
- 93803-87-3
- Molecular formula:
- UVCB
- IUPAC Name:
- 2-octyldodecyl 3-methylheptadecanoate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: pale yellow liquid
- Analytical purity: 100% (UVCB)
- Lot/batch No.: N567701
- Storage condition of test material: at room temperature in the dark
- Other: density approximately 860 kg/m³ (25 ºC)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Swiss, CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: approximately 7 weeks
- Weight at study initiation: 31.2-32.4 (males, range of mean group values), 24.2-25.8 (females, range of mean group values)
- Assigned to test groups randomly: yes, assigned to treatment groups as they came to hand from delivery boxes
- Fasting period before study: no
- Housing: Five animals per sex per group were housed in labelled polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, the Netherlands)
- Diet: standard pelleted laboratory animal diet (Carfil Quality BVBV, Oud-Turnhout, Belgium)
- Water: tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
dosing solutions were prepared directly prior to administration by dissolving the test substance in corn oil. The dosing volume was 10 mL/kg bw. - Duration of treatment / exposure:
- Not applicable
- Frequency of treatment:
- Single treatment
- Post exposure period:
- 24 or 48 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1000 and 2000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- The positive control animals were dosed with cyclophosphamide.
- Route of administration: intraperitoneal injection
- Doses / concentrations: 50 mg/kg bw
Examinations
- Tissues and cell types examined:
- Tissue: bone marrow
Cell type: bone marrow cells - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
A suitable dose range for the micronucleus test was selected based on the results of a dose range-finding study. Two dose groups, each comprising 3 males and 3 females, received a single dose of the test substance. The animals were observed for 3 days, during which mortality and physical condition were recorded daily.
TREATMENT AND SAMPLING TIMES (in addition to information in specific fields):
The animals were dosed once and sacrificed by cervical dislocation at 24 or 48 h (2000 mg/kg bw test substance and vehicle control) or 24 h only (500 and 1000 mg/kg bw test substance, and positive control group)
DETAILS OF SLIDE PREPARATION:
The femur bone was removed, and the bone marrow canal exposed and flushed with approximately 2 mL of foetal calf serum. The cell suspension was collected and centrifuged at 1000 rpm (approximately 100 g) for 5 min. The supernatant was removed with a Pasteur pipette. A drop of serum was left on the pellet. The cells in the sediment were carefully mixed with the serum by aspiration with the remaining serum. A drop of the cell suspension was placed on the end of a slide which was previously cleaned (24 h immersed in a 1:1 mixture of 96% (v/v) ethanol/ether and cleaned with a tissue) and marked (with the NOTOX study identification number and the animal number). The drop was spread by moving a clean slide at an angle of approximately 45° over the slide with the drop of bone marrow suspension. The preparations were then air-dried, fixed for 5 min in 100% methanol and air-dried overnight. Two slides were prepared per animal.The slides were automatically stained using the 'Wright-stain-procedure' in an 'Ames' HEMA-tek slide stainer (Miles, Bayer Nederland B.V.). The dry slides were dipped in xylene before they were embedded in MicroMount and mounted with a coverslip.
METHOD OF ANALYSIS:
Slides were scored at a magnification of 1000 x. The number of micronucleated polychromatic erythrocytes was counted in 2000 polychromatic erythrocytes. The ratio polychromatic to normochromatic erythrocytes was determined by counting and differentiating the first 1000 erythrocytes at the same time. Micronuclei were only counted in polychromatic erythrocytes. - Evaluation criteria:
- A micronucleus test is considered acceptable if it meets the following criteria:
a) The positive control substance induced a statistically significant (Wilcoxon Rank Sum Test, two-sided test at P < 0.05) increase in the frequency of micronucleated polychromatic erythrocytes.
b) The incidence of micronucleated polychromatic erythrocytes in the control animals should reasonably be within the laboratory historical control data range.
A test substance is considered positive in the micronucleus test if:
It induced a biologically as well as a statistically significant (Wilcoxon Rank Sum Test; two-sided test at P < 0.05) increase in the frequency of micronucleated polychromatic erythrocytes (at any dose or at any sampling time) in the combined data for both sexes or in the data for male or female groups separately.
A test substance is considered negative in the micronucleus test if:
None of the tested concentrations or sampling times showed a statistically significant (P < 0.05) increase in the incidence of micronucleated polychromatic erythrocytes neither in the combined data for both sexes nor in the data for male or female groups alone.
The preceding criteria are not absolute and other modifying factors may enter into the final evaluation decision. - Statistics:
- The Wilcoxon Rank Sum Test; two-sided test (P < 0.05) was for all statistical calculations.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 1000 and 2000 mg/kg bw
- Clinical signs of toxicity in test animals: no effects were observed
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): no increase in the frequency of micronucleated polychromatic erythrocytes was observed in the polychromatic erythrocytes from the bone marrow of test substance treated animals (see Table 1 and 2). The positive control substance (cyclophosphamide) induced a statistically significant increase in the number of micronucleated polychromatic erythrocytes in both sexes, showing the positive control was valid.
- Ratio of PCE/NCE (for Micronucleus assay): The animals of the groups that were treated with the test substance did not show a decrease in the ratio of polychromatic to normochromatic erythrocytes compared with the vehicle controls. As the highest dose of the test substance was the recommended limit dose according to the guideline, the study result is acceptable, despite the lack of toxicity at the highest dose level. The groups that were treated with cyclophosphamide showed a decrease in the ratio of polychromatic to normochromatic erythrocytes compared with the vehicle controls.
Any other information on results incl. tables
Table 1: Results of the in vivo micronucleus assay in male animals
Exposure group |
Sampling time (h) |
Number of animals |
Number of micronucleated PCEs/ 2000 PCEs (mean±SD) |
Ratio PCEs/ NCEs (mean±SD) |
Vehicle (corn oil) |
24 |
5 |
0.4±0.5 |
0.99±0.02 |
Vehicle (corn oil) |
48 |
5 |
0.2±0.4 |
1.01±0.04 |
500 mg/kg bw |
24 |
5 |
0.8±0.8 |
1.00±0.03 |
1000 mg/kg bw |
24 |
5 |
0.2±0.4 |
0.99±0.01 |
2000 mg/kg bw |
24 |
5 |
0.6±0.9 |
1.01±0.04 |
2000 mg/kg bw |
48 |
5 |
0.4±0.5 |
1.00±0.01 |
Cyclophosphamide |
48 |
5 |
25.0±8.0* |
0.51±0.20 |
PCE = polychromatic erythrocyte
NCE = normochromatic erythrocytes
*Significantly different from corresponding control group (Wilcoxon Rank Sum Test, P < 0.05)
Table 2: Results of the in vivo micronucleus assay in female animals
Exposure group |
Sampling time (h) |
Number of animals |
Number of micronucleated PCEs/ 2000 PCEs (mean±SD) |
Ratio PCEs/ NCEs (mean±SD) |
Vehicle (corn oil) |
24 |
5 |
0.6±0.9 |
1.01±0.02 |
Vehicle (corn oil) |
48 |
5 |
0.0±0.0 |
0.99±0.02 |
500 mg/kg bw |
24 |
5 |
1.2±0.8 |
1.02±0.02 |
1000 mg/kg bw |
24 |
5 |
0.6±0.5 |
0.98±0.02 |
2000 mg/kg bw |
24 |
5 |
0.4±0.5 |
0.99±0.07 |
2000 mg/kg bw |
48 |
5 |
0.4±0.5 |
1.00±0.02 |
Cyclophosphamide |
48 |
5 |
13.2±2.8* |
0.56±0.05 |
PCE = polychromatic erythrocyte
NCE = normochromatic erythrocytes
*Significantly different from corresponding control group (Wilcoxon Rank Sum Test, P < 0.05)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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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