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EC number: 293-165-5 | CAS number: 91052-08-3
- 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Chinese hamster lung cells (CHL/IU)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM medium supplemented with 10% calf serum
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- 6h treatment with and without S9 mix: 891, 1783, 3565 µg/mL
24h treatment without S9 mix: 55.7, 111, 223, 446 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of vehicle: due to limited solubility of the test substance in water, DMSO was selected as vehicle.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: mitomycin C (MMC), 0.1 µg/mL (6h exposure), 0.05 µg/mL (24h exposure); +S9: cyclophosphamide (CM), 10 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 6 h (short treatment) and 24 h (continuous treatment)
- Expression time (cells in growth medium): 18 h (after 6 h treatment)
- Fixation time (start of exposure up to fixation or harvest of cells): 24 h
SPINDLE INHIBITOR: 0.2 μg/mL of colcemid (added 2 h prior to harvest)
STAIN: 1.2% Giemsa stain (in sodium phosphoric acid buffer 1/100 mol/L pH 6.8) for 12 min
NUMBER OF REPLICATIONS: 2 replications in one experiment
NUMBER OF CELLS EVALUATED: 100 per culture
DETERMINATION OF CYTOTOXICITY
- Method: relative cell growth
OTHER EXAMINATIONS:
- Determination of polyploidy: Yes - Evaluation criteria:
- 100 cells/plate were observed and classified into gap, ctd (chromatid break), cte (chromatid exchange), csb (chromosome break), cse (chromosome exchange) and oth (others). The total number of cells with aberrations excluding gaps was calculated. The number of polyploid cells was also counted.
The test results were considered positive, if a statistically significant increase in the frequency of chromosome aberrations was observed, the increase showed dose-dependency and it was reproducible. - Statistics:
- Differences in chromosome aberration frequencies between treated and control cells were analysed with the Fisher's exact test (p < 0.025). Dose-dependency was assessed using the Cochran Armitage trend test.
Results and discussion
Test results
- Key result
- Species / strain:
- mammalian cell line, other: Chinese hamster lung cells (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 446 µg/mL (24 h treatment, without metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: the test substance was not soluble in water.
- Precipitation: visible precipitation was noted at 223 µg/mL and above.
RANGE-FINDING/SCREENING STUDIES:
To find the appropriate concentration range, a cytotoxicity test was performed at test concentrations of 3565, 1783, 891, 446, 223, 111, 55.7, 27.9, 13.9, 6.96 µg/mL. Cytotoxicity was evaluated both after a continuous 24 h exposure (-S9 mix) and a short-term 6 h exposure (± S9 mix) followed by an 18 h recovery period prior to harvest.
The test substance was not cytotoxic after short-term exposure at any concentration in the presence of S9 mix. Without metabolic activation, relative growth was reduced to about 71% of the control value.
After 24 h continuous treatment without S9 mix, the test substance was not cytotoxic up to 1783 µg/mL. At 3565 µg/mL, relative growth was decreased to ca. 13 % of the control value. The concentration leading to 50% cytotoxicity was calculated to be 2738 µg/mL.
Based on these results, the main test was conducted using the following test substance concentrations:
6 h treatment (± S9 mix): 891, 1783 and 3565 µg/mL
24 h treatment (-S9 mix): 55.7, 111, 223 and 446 µg/mL
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the main test, no cytotoxic effects were observed after short-term exposure. The test substance was cytotoxic at 446 µg/mL after the 24 h treatment. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Results of main study (short-term treatment) and additional study (continuous treatment)
Test item |
Concentration |
Relative cell growth |
Aberrant cells in % |
|
|
in μg/mL |
in % |
with gaps |
without gaps |
Exposure period 6h, fixation time 18h, without S9 mix |
||||
DMSO |
|
100 |
1 |
1 |
Glycerol monooleate |
891 a) |
121.8 |
0 |
1 |
|
1783 a) |
114.8 |
1 |
0 |
|
3565 a) |
101.1 |
1.5 |
0.5 |
MMC |
0.1 |
77.5 |
4.5 |
36* |
Exposure period 6h, fixation time 18h, with S9 mix |
||||
DMSO |
|
100 |
0.5 |
0 |
Glycerol monooleate |
891 a) |
135.9 |
2 |
2 |
|
1783 a) |
123.9 |
1 |
0.5 |
|
3565 a) |
111.4 |
1 |
0.5 |
CP |
12.5 |
83.4 |
3.5 |
19.5* |
Exposure period 24h, without S9 mix |
||||
DMSO |
|
100 |
1 |
1 |
Glycerol monooleate |
55.7 |
99 |
0.5 |
0 |
|
111 |
105.9 |
1 |
1 |
|
223 a) |
87.0 |
0.5 |
0 |
|
446 a) |
91.6 |
Toxic |
|
MMC |
0.05 |
104.4 |
6.5 |
25* |
*: Significant difference from control (Fisher's exact test, p < 0.025)
a): Visible precipitation was observed at the end of exposure period.
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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