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EC number: 629-704-1 | CAS number: 226995-92-2
- 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
The substance was negative in the Ames test (bacterial reverse mutation assay) employing Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102, both in the presence and absence of a metabolic activation system (rat liver S9).
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 November 2001 - 24 December 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)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Batch number: CW-4896
Storage conditions: at room temperature
Purity: 85.9% actives
Expiry: 2 years from receipt - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: rfa mutation; uvrB mutation, inclusion of plasmid pKM 101 has been added to strains TA98, TA100 and TA102; pAQ1 tetracycline resistant plasmidic factor has been added to the TA102 strain.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver post-mitochondrial (S9) fraction from rats induced with Aroclor 1254.
- Test concentrations with justification for top dose:
- Preliminary test: the substance was poorly soluble and toxic at the highest dose employed (5000 µg/plate). The doses chosen for the main test were based on level of precipitation and toxicity.
Main test: 156.25, 312.5, 625, 1250 and 2500µg/plate for all tester strains, with and without S9.
Main test 2: 78.125, 156.25, 312.5, 625 and 1250 µg/platefor all tester strains, with and without S9. - Vehicle / solvent:
- Dimethyl sulphoxide (DMSO).
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-Anthramine
- Rationale for test conditions:
- As per guideline.
- Evaluation criteria:
- A reproducible 2-fold increase in the number of revertants compared with controls, in any strain at any dose level and/or evidence of dose-response relationship was considered as positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Moderate to marked cytotoxicity was observed at concentration of 1250µg/plate and above in the absence of S9 and at 2500 µg/plate in the presence of S9.
- 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:
- cytotoxicity
- Remarks:
- Moderate to marked cytotoxicity was observed at concentration of 1250µg/plate and above in the absence of S9 and at 2500 µg/plate in the presence of S9.
- 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:
- cytotoxicity
- Remarks:
- Moderate to marked cytotoxicity was observed at concentration of 1250µg/plate and above in the absence of S9 and at 2500 µg/plate in the presence of S9.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Moderate to marked cytotoxicity was observed at concentration of 1250µg/plate and above in the absence of S9 and at 2500 µg/plate in the presence of S9.
- 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:
- cytotoxicity
- Remarks:
- Moderate to marked cytotoxicity was observed at concentration of 1250µg/plate and above in the absence of S9 and at 2500 µg/plate in the presence of S9.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- In the TA 1537 strain, some two-fold increases in the number of revertants were noted. However, since these increases were very slight (up to 2.6-fold the vehicle control value) and in the absence of a dose-response relationship, they were considered as artefactual by the study facilitators and attributed to the low number of revertants in the vehicle control and therefore considered as not relevant.
- Conclusions:
- The substance did not induce any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102.
- Executive summary:
In the in vitro genotoxicity study (Ames test) the substance was tested for mutagenicity in Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA 102. Concentrations of up to 5000 μg/plate were tested in the preliminary study. The substance was poorly soluble and toxic at the highest dose employed (5000 µg/plate). The doses chosen for the main test were based on level of precipitation and toxicity. In the main test the doses employed were 156.25, 312.5, 625, 1250 and 2500µg/plate for all tester strains, with and without S9. In the second main test the concentration employed were 78.125, 156.25, 312.5, 625 and 1250 µg/platefor all tester strains, with and without S9. No evidence of mutagenic activity was seen at any concentration of the substance in either test. Moderate to marked cytotoxicity was observed at concentration of 1250µg/plate and above in the absence of S9 and at 2500 µg/plate in the presence of S9. 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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the findings of a reliable reverse bacterial mutagenicity study conducted on the substance, classification of the substance is not justified.
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