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Diss Factsheets
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EC number: 203-517-1 | CAS number: 107-74-4
- 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)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test item gave no indication for a genotoxic potential in an Ames test performed on five tester strains of Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA1538 and TA98) both with and without S9 mix.
An in vitro gene mutation study in mammalian cells does not to be conducted because adequate data from a reliable in vivo mammalian gene mutation test are available.test substance.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- up to 3600 µg/plate with and without S-9 mix
Positive controls: sodium azide and benzo[a]pyrene
Results that met the following additional criteria were regarded as positive: reproducible, dose-related and at least two-fold elevation of the spontaneous revertant frequency - GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Supplier: ICN, ICNK &K: Plainview, NY, USA
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- up to 3600 µg/plate
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- Details on test system and experimental conditions:
- not further specified
- Evaluation criteria:
- Results that met the following additional criteria were regarded as positive: reproducible, dose-related and at least two-fold elevation of the spontaneous revertant frequency
- Statistics:
- not further specified
- Key result
- Species / strain:
- other: all strains tested
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- The test item gave no indication for a genotoxic potential in an Ames test performed on five tester strains of Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA1538 and TA98) both with and without S9 mix.
- Executive summary:
The test item gave no indication for a genotoxic potential in an Ames test performed on five tester strains of Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA1538 and TA98) both with and without S9 mix.
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- An in vitro gene mutation study in mammalian cells does not to be conducted because adequate data from a reliable in vivo mammalian gene mutation test are available.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
The micronucleus test on mouse bone marrow was performed to determine the mutagenic effects of the test substance. The test substance was tested at dose levels of 0, 516, 860 and 1204 mg/kg. The test substance failed to produce genetic effects in the micronucleus test on mouse bone marrow cells and is negative for gene mutation in vivo.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Type of assay:
- other: mammalian erythrocyte micronucleus test (migrated information)
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 - 14 weeks - Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: olive oil
- Duration of treatment / exposure:
- 30 h
- Frequency of treatment:
- 1x
- Post exposure period:
- 30 h
- Dose / conc.:
- 516 mg/kg bw (total dose)
- Dose / conc.:
- 860 mg/kg bw (total dose)
- Dose / conc.:
- 1 204 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 4
- Tissues and cell types examined:
- polychromatic erythrocytes of bone marrow
- Details of tissue and slide preparation:
- The smears were stained according to the method of Schmid (Schmid W. 1976; Chemical Mutagens; edited by A . Hollaender; Vol4; p31; Plenum Press, New York). Slides were scored as described by Wild (Wild D. 1980; Archs Toxicol.; 43; 249).
- Evaluation criteria:
- No. of polychromatic erthrocytes
- Statistics:
- Statistical significance was determined according to the methods of Kastenbaum & Bowman (Kastenbaum M. 1970; Mutation Res. 9; 527).
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Mortality 3/7 animals at highest dose
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- The substance was negative in an viivo micronucleus study in mice as it did not produce genetic effects on mouse bone marrow cells.
- Executive summary:
The micronucleus test on mouse bone marrow was performed to determine the mutagenic effects of the test substance. The test substance was tested at dose levels of 0, 516, 860 and 1204 mg/Kg.
The test substance failed to produce genetic effects in the micronucleus test on mouse bone marrow cells and is negative for gene mutation in vivo.
Reference
DOSE: mean number of micronucleated polychromatic erythrocytes (PE) per 1000 PE
516 mg/kg bw: 2.2 (4/4 animals survived)
860 mg/kg bw: 2.2 (4/4 animals survived)
1204 mg/kg bw: 2.6 (3/7 animals survived)
vehicle control: 2.0 (4/4 animals survived)
mean of the vehicle controls for all substances tested: 1.85
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The test item gave no indication for a genotoxic potential in an Ames test performed on five tester strains of Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA1538 and TA98) both with and without S9 mix.
An in vitro gene mutation study in mammalian cells does not to be conducted because adequate data from a reliable in vivo mammalian gene mutation test are available.
The micronucleus test on mouse bone marrow was performed to determine the mutagenic effects of the test substance. The test substance was tested at dose levels of 0, 516, 860 and 1204 mg/kg. The test substance failed to produce genetic effects in the micronucleus test on mouse bone marrow cells and is negative for gene mutation in vivo.
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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