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EC number: 270-331-5 | CAS number: 68424-95-3
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
There are no studies available for the assessment of in vitro genotoxicity of the substance. However, there is a reliable in vitro studies available for a structurally similar substance. The substance (at concentrations up to 50 µg/plate) was found to be negative for mutagenicity in the reverse mutation assay (Ames) employing Salmonella typhimurium strains TA1535, TA1537, TA98, TA102 and TA100 in the presence and absence of a metabolic activation system.
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:
- 20 March 2001 - 22 March 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% liver S9 in standard co-factors.
- Test concentrations with justification for top dose:
- Doses were selected based on a range finder study.
using 0.05 to 15 µg/plate without S9.
Dose range finder using 0.15 to 50 µg/plate with S9. - Vehicle / solvent:
- Dimethyl sulphoxide.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Vehicle
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 1,8-Dihydroxyanthraquinone
- Evaluation criteria:
- The test material should have induced a reproducible, dose-related and statistically (Dunnett's method of linear regression) significant increase in the revertant count in at least one strain of bacteria.
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- The substance (at concentrations up to 50 µg/plate) was found to be negative for mutagenicity in the reverse mutation assay employing Salmonella typhimurium strains TA1535, TA1537, TA98, TA102 and TA100 in the presence and absence of a metabolic activation system.
- Executive summary:
In the in vitro genotoxicity study (Ames test) the substance was tested for mutagenicity in Salmonella typhimurium strains TA1535, TA1537, TA98, TA102 and TA100. Concentrations of up to 50 μg/plate were tested. No evidence of mutagenic activity was seen at any concentration of the substance in the presence and absence of a metabolic activation system. It was concluded that the substance showed no evidence of mutagenic activity in this bacterial system under the test conditions employed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
There are no studies available for the assessment of in vivo genotoxicity of the substance. However, there is a reliable in vivo study available for a structurally similar substance. The substance was found to be negative for chromosomal damage in rat bone marrow in the in vivo cytogenetic test when administered orally by gavage.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 September 1986 - 20 January 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Read-across
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Version / remarks:
- 1984
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1984
- GLP compliance:
- yes
- Type of assay:
- other: Micronucleus assay
- Specific details on test material used for the study:
- Batch number: E06130085
Purity: 50.3% - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CRL UK
- Assigned to test groups randomly: yes
- Fasting period before study: overnight prior to dosing
- Housing: plastic disposable cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Air changes (per hr): 30
- Photoperiod (hrs dark / hrs light): 12 hours artifical light/day
- Route of administration:
- oral: gavage
- Vehicle:
- Sterile distilled water.
- Details on exposure:
- All animals in all groups were dosed by oral gavage with a standard volume of 20 ml/kg bw except that those receiving cyclophosphamide were dosed by IP injection.
- Duration of treatment / exposure:
- Single administration of dose.
- Frequency of treatment:
- Once.
- Post exposure period:
- 48 hours
- Dose / conc.:
- 600 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 35/sex/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
40 mg/kg bw/day
Prepared in a solution in sterile 0.9% saline at a concentration of 2.0 mg/ml. - Tissues and cell types examined:
- Both femurs were dissected from the animals and the proximal epiphysis was remoaved and the marrow eluted.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: A preliminary toxicity test was conducted to evaluate the toxicity of the substance at various doses. The dose selcted for the main test was based on the lowest dose that did not result in any toxicity.
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- The substance was found to be negative for chromosomal damage in rat bone marrow in the in vivo cytogenetic test when administered orally by gavage.
- Executive summary:
The substance was assessed for its potential to induce chromosomal damage in rats dosed by oral gavage at a dose of 600 mg/kg bw. The animals were observed for 48 hours for any signs of toxicity. Two hours prior to sacrifice the animals each received a dose of colchicine to arrest cells in the metaphase stage of cell division. At the end of the observation period the animals were terminated by cervical dislocation and the bone marrow from the femurs were removed for analysis. The substance was found to be negative for chromosomal damage in rat bone marrow in the in vivo cytogenetic test when administered orally by gavage.
Reference
Sampling time (hrs) | Treatment | Doseage (mg/kg bw) | Incidence of aberrant cells (%) | |
Excluding gap damage | Including gap damage | |||
6 | Vehicle P0151 |
- 600 |
0 0 |
0 0 |
24 | Vehicle P0151 Cyclophosphamide |
- 600 40 |
0 0 5.6 |
0 0 5.6 |
48 | Vehicle P0151 |
- 600 |
0 0 |
0 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Based on the findings of three reliable in vitro and one reliable in vivo genotoxicity studies conducted on a structurally similar substance, classification of the substance is not justified.
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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