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EC number: 262-108-6 | CAS number: 60209-82-7
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 Apr - 15 May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- (adopted July 21, 1997).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: cultured peripheral human lymphocytes
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640, supplemented with 20% (v/v) heat-inactivated foetal calf serum, L-glutamine (2 mM), penicillin/streptomycin (50 U/ml and 50 µg/ml respectively) and 30 U/ml heparin.
- 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 ß-naphthoflavone
- Test concentrations with justification for top dose:
- 3 h exposure time: 10, 33 and 100 µg/mL (with and without S9 mix)
24 h exposure time: 66, 150 and 250 µg/mL (without S9 mix)
48 h exposure time: 3, 125 and 150 µg/mL (without S9 mix)
(At a concentration of 100 µg/mL isopropyl laurate precipitated in the culture medium) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: cyclophosphamide (10 µg/mL, with S9); mitomycin C (0.5 µg/mL for a 3 h exposure period, 0.2 µg/mL for a 24 h exposure period and 0.1 µg/mL for a 48 h exposure period without S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 3, 24 and 48h
- Fixation time (start of exposure up to fixation or harvest of cells): 24 and 48 h for 3 h treatment period; 48 h for 48 h treatment period
SPINDLE INHIBITOR (cytogenetic assays): colchicine 0.5 µL/mL medium
STAIN (for cytogenetic assays): Giemsa 5% (v/v) in tap water
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 100 per culture
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index of 1000 cells
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- A test substance was considered positive (clastogenic) in the chromosome aberration test; it induced a dose-related statistically significant (Chi-square test, one-sided, p < 0.05) increase in the number of cells with chromosome aberrations; a statistically significant and biologically relevant increase in the frequencies of the number of cells with chromosome aberrations was observed in the absence of a clear dose-response relationship.
A test substance was considered negative (not clastogenic) in the chromosome aberration test if none of the tested concentrations induced a statistically significant (Chi-square test, one-sided, p < 0.05) increase in the number of cells with chromosome aberrations. The preceding criteria are not absolute and other modifying factors might enter into the final evaluation decision. - Statistics:
- Chi-square test, one-sided, p < 0.05
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: cultured human peripheral lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 150 µg/mL (exposure period 24 h, fixation time 24 h, -S9 mix) and at 125 µg/mL (exposure period 48 h, fixation time 48 h, -S9 mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At a concentration of 100 µg/mL isopropyl laurate precipitated in the culture medium
- Polyploidy did also not occur in a significant way and was also observed in control group.
RANGE-FINDING/SCREENING STUDIES: The highest concentration analysed was selected based on the solubility of the test substance in the culture medium (3 h and 24 h continuous exposure) or on toxicity, inhibition of the mitotic index of about 50% or greater (48 h continuous exposure).
COMPARISON WITH HISTORICAL CONTROL DATA: Negative controls were in range of the historical control data from experiments performed between January 2007 and December 2009.
Any other information on results incl. tables
Table 1: Cytotoxic and Genotoxic observations
Test item |
Concentration |
Mitotic Index |
Aberrant cells in % |
|
|
in µg/mL |
in % |
with gaps |
without gaps |
Exposure period 3h, fixation time 24h, without S9 mix |
||||
Ethanol |
1.0% (v/v) |
100 |
6 |
4 |
MMC |
0.5 |
97 |
56 |
56 |
Test substance |
10 |
97 |
6 |
1 |
33 |
92 |
4 |
2 |
|
100 |
81 |
2 |
2 |
|
Exposure period 3h, fixation time 24h, with S9 mix |
||||
Ethanol |
1.0% (v/v) |
100 |
7 |
3 |
CP |
0.5 |
59 |
52 |
50 |
Test substance |
10 |
101 |
7 |
7 |
33 |
96 |
2 |
2 |
|
100 |
91 |
5 |
3 |
|
Exposure period 24h, fixation time 24h, without S9 mix |
||||
Ethanol |
1.0% (v/v) |
100 |
3 |
3 |
MMC |
0.2 |
86 |
45 |
45 |
Test substance |
66 |
96 |
1 |
1 |
150 |
55 |
4 |
4 |
|
250 |
41 |
2 |
2 |
|
Exposure period 48h, fixation time 48h, without S9 mix |
||||
Ethanol |
1.0% (v/v) |
100 |
3 |
3 |
MMC |
0.1 |
89 |
56 |
56 |
Test substance |
3 |
94 |
6 |
6 |
125 |
70 |
3 |
3 |
|
150 |
46 |
5 |
5 |
|
Exposure period 3h, fixation time 48h, with S9 mix |
||||
Ethanol |
1.0% (v/v) |
100 |
2 |
2 |
CP |
10.0 |
-- |
42 |
42 |
Test substance |
10 |
99 |
0 |
0 |
33 |
96 |
0 |
0 |
|
100 |
95 |
1 |
1 |
MMC: Mitomycin
CP: Cyclophosphamide
Applicant's summary and conclusion
- Conclusions:
- 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.
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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