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EC number: 201-061-8 | CAS number: 77-83-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vivo
Description of key information
Link to relevant study records
- Endpoint:
- in vivo mammalian germ cell study: gene mutation
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Schmid W (1976) The micronucleus test for cytogenetic analysis. In Chemical Mutagens. Edited by Hollaender A. Vol. 4. p 31. Plenum Press, New York.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 10 wk to 14 wk
- Weight at study initiation: No data
- Assigned to test groups randomly: [no/yes, under following basis: ]
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): - Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle used: olive oil
- Justification for choice of solvent/vehicle:
- Concentration of test material in vehicle:
- Amount of vehicle (if gavage or dermal): - Duration of treatment / exposure:
- 30 hr
- Frequency of treatment:
- Treated only once
- Remarks:
- Doses / Concentrations:
1856 mg/kg bw
Basis:
no data - Remarks:
- Doses / Concentrations:
1237 mg/kg bw
Basis:
no data - Remarks:
- Doses / Concentrations:
619 mg/kg bw
Basis:
no data - No. of animals per sex per dose:
- 4
- Control animals:
- yes
- Positive control(s):
- No data
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION:
- Mice were killed and bone marrow smears were prepared 30 hr after treatment.
- The smears were stained according to the method of Schmid (1976). - Statistics:
- Statistical significance was determined according to the methods of Kastenbaum & Bowman (1970) Tables for determining the statistical significance of mutation frequencies. Mutation Research 9: 527
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Conclusions:
- Interpretation of results : negative
Wild et al. found that the test material was not genotoxic up to a concentration of 1856 mg/kg body weight in a mouse micronucleus test.
Reference
Results on mouse bone marrow:
Dose (mg/kg body weight) | Surviving:treated mice | Mean No. of micronucleated polychromatic erythrocytes (PE)/1000 PE |
1856 | 4:4 | 1.7 |
1237 | 4:4 | 1.7 |
619 | 4:4 | 1.3 |
0 (control) | 4:4 | 1.9 |
No significant difference between the control and treated groups.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
A variety of studies have been performed on the genotoxicity of the substance. Wild et al. (1982) conducted an Ames test, a Basc (Drosophila melanogaster) test, and a mouse micronucleus test on the substance. Galloway et al. (1987) performed a chromosome aberration test and a sister chromatid exchange test.
The mouse micronucleus test by Wild et al. (1982) differs from the current guidelines particularly only a single time point of 30 hours was employed. At the time the study was performed 3 time points were common; 24, 48 and 72 hours. The Ames test lacks testing on E. coli when compared to the current guidelines.
As a consequence of (1) the negative mouse micronucleus test (Wild et al. 1982) (2) the negative Ames test both with and without metabolic activation (Wild et al. 1982), (3) the negative chromosome aberration test with metabolic activation (Galloway et al. 1987), and (4) the negative sister chromatid exchange test (Galloway et al. 1987), the test material can be considered negative for genetic toxicity.
In coming to this conclusion, two results have to be discounted: (1) The Basc test (Wild et al. 1982) was weakly positive but used as a model organism a species of fruit fly, Drosophila melanogaster, that is not especially analogous to humans. This is also not a standard test required by Regulation (EC) No. 1907/2006, but was available in the scientific literature. (2) The chromosome aberration test without metabolic activation was ambiguous (Galloway et al. 1987), but was negative with metabolic activation and metabolic activation can reasonably be expected in vivo.
Genetic toxicity is a concern for toxicology in part because genotoxic substances are often mutagenic, which often leads to carcinogenicity. The availability of a long-term in vivo study that found no neoplastic histopathological effects (Dunnington et al. 1981) supports the finding that the test material is not genotoxic.
As a consequence of the findings of the chromosome aberration test performed by Galloway et al. (1987), an in vitro gene mutation study in mammalian cells was not performed.
Justification for selection of genetic toxicity endpoint
In vivo study.
Justification for classification or non-classification
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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