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Diss Factsheets
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EC number: 456-830-2 | CAS number: 745070-61-5
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-11-08 to 2004-12-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant; Guideline Study (OECD 471)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Guideline "Genotoxicity: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals"
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EMEA Guideline"ICH Topic S2A - Genotoxicity: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals" (CPMP/ICH/141/95)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
- Target gene:
- his +/- (S. typhimurium); trp+/- (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction derived from liver of phenobarbitone/B-naphtoflavone treated rats
- Test concentrations with justification for top dose:
- 1, 0.316, 0.1, 0.0316, and 0.01 mg/plate (main study)
0.2, 0.1, 0.05, 0.025, and 0.0125 mg/plate (repeat study) - Vehicle / solvent:
- - Vehicle: DMSO
- Justification for choice of solvent/vehicle: DMSO was found to be suitable for dissolving the test item
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9
Migrated to IUCLID6: S. typh. TA 100, TA 1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9
Migrated to IUCLID6: S.typh. TA 98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9
Migrated to IUCLID6: S.typh. TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9
Migrated to IUCLID6: E.coli WP2 uvrA
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminofluorene; S.typh. TA 98, TA 100, TA 1537
- Remarks:
- with S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene; S.typh. TA 1535, E.coli WP2 uvrA
- Remarks:
- with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 60 - 70 minutes in an agitated water bath at 37 ± 0.5°C
- Incubation of plates: main study: 72 h at 37 ± 2°C; repeat study: 65 h at 37 ± 2°C
NUMBER OF STUDIES: 2 (main and repeat study)
NUMBER OF REPLICATIONS: triplicates
DETERMINATION OF CYTOTOXICITY AND PRECIPITATION:
- Cytotoxicity was determined by microscopic analysis (100 - 200 fold magnification) of the plates tested with the highest test item concentration.
- Precipitation was determined by visual control after pre-incubation and microscopically after incubation of plates tested. - Evaluation criteria:
- A mutagenic potential of a test item was assumed if one quotient of the mean value of the respective revertant colonies over the mean value of the respective negative control is 2.0 or higher. A dose effect relationship could underline this conclusion.
A possible mutagenic potential of a test item was assumed if one quotient of the mean value of the respective revertant colonies over the mean value of the respective negative control ranges between 1.7 to 1.9 in combination with a dose effect relationship.
No mutagenic potential of a test item was assumed if all quotients of the mean value of the respective revertant colonies over the mean value of the respective negative control range between 1.0 (or lower) to 1.6. The absence of a dose effect relationship could underline this conclusion.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- PRECIPITATION:
- Main study: after the pre-incubation period precipitation at test item concentrations of 1 and 0.316 mg/plate, after the incubation phase precipitation at a concentration of 0.1 mg/plate.
- Repeat study: after the pre-incubation period precipitation at test item concentrations of 0.2 and 0.1 mg/plate, after the incubation phase precipitation at a concentration of 0.05 mg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: The number of revertants in control and test item plates were within the historical control data range.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Neither in the main nor in the repeat studies any signs of cytotoxicity were observed. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
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.
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