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EC number: 619-856-7 | CAS number: 1056196-56-5
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Straße 7, D-55116 Mainz
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 33470-153-FK
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature.
- Stability under test conditions: The stability of the test substance under storage conditions throughout the study period was guaranteed by the sponsor.
- Solubility and stability of the test substance in the solvent/vehicle: DMSO was used as vehicle due to the limited solubility in water. The stability of the test substance in the vehicle DMSO was not determined analytically. However, the suitability of DMSO as vehicle had been demonstrated in bacterial reverse mutation tests and historical control data are available.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The substance was dissolved in dimethylsulfoxide (DMSO). To achieve a solution of the test substance in the vehicle, the test substance preparation was shaken thoroughly.
FORM AS APPLIED IN THE TEST (if different from that of starting material): solution in DMSO
Method
- Target gene:
- his gene, trp gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- 20, 100, 500, 2500 and 5000 μg/plate (SPT)
312.5, 625, 1250, 2500 and 5000 μg/plate (PIT)
In agreement with the recommendations of current guidelines 5 mg/plate or 5 μL/plate are generally selected as maximum test dose at least in the 1st Experiment. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controls
- Untreated negative controls:
- other: not applicable
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- other: 2-aminoanthracene (2-AA) with S9 mix for strains: TA 1535, TA 100, TA 1537, TA 98, WP2. N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) without S9 mix for strains: TA 1535, TA 100. 4-nitro-o-phenylendiamine (NOPD) without S9 mix for strain T98.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 min (PIT)
- Exposure duration: 48 - 72 (SPT and PIT)
DETERMINATION OF CYTOTOXICITY
- Method: Toxicity detected by a decrease in the number of revertants, clearing or diminution of the background lawn (= reduced his- or trp- background growth) and/or reduction in the titer is recorded for all test groups both with and without S9 mix in all experiments - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance is generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- weak bacteriotoxic effect from 2500 ug/plate onwards, precipitation at 500 ug/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- weak bacteriotoxic effect from 2500 ug/plate onwards, precipitation at 500 ug/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- weak bacteriotoxic effect from 2500 ug/plate onwards, precipitation at 500 ug/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- weak bacteriotoxic effect from 2500 ug/plate onwards, precipitation at 500 ug/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- weak bacteriotoxic effect from 2500 ug/plate onwards, precipitation at 500 ug/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Test substance precipitation was found from about 500 μg/plate onward with and without S9 mix.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: the positive control substances both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical positive control data or above.
- Negative (solvent/vehicle) historical control data: In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
Any other information on results incl. tables
Table 1: Summary of Results
Experiments | Metabolic activation | Strains | Result |
Standard plate test | Tests without S9 mix | TA 1535 | No relevant increase in the number of his+ or trp+ revertants. |
TA 100 | |||
TA 1537 | |||
TA 98 | |||
E. coli WP2 uvrA | |||
Tests with S9 mix | TA 1535 | No relevant increase in the number of his+ or trp+ revertants. | |
TA 100 | |||
TA 1537 | |||
TA 98 | |||
E. coli WP2 uvrA | |||
Preincubation test | Tests without S9 mix | TA 1535 | No relevant increase in the number of his+ or trp+ revertants. |
TA 100 | |||
TA 1537 | |||
TA 98 | |||
E. coli WP2 uvrA | |||
Tests with S9 mix | TA 1535 | No relevant increase in the number of his+ or trp+ revertants. | |
TA 100 | |||
TA 1537 | |||
TA 98 | |||
E. coli WP2 uvrA |
Applicant's summary and conclusion
- Conclusions:
- The test material is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in absence and presence of metabolic activation.
- Executive summary:
The test material was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay.
STRAINS: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA
DOSE RANGE: 20 μg - 5000 μg/plate (SPT) and 312.5 μg - 5000 μg/plate (PIT)
TEST CONDITIONS: Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (Aroclor-induced rat liver S9 mix).
SOLUBILITY: Precipitation of the test substance was found from about 500 μg/plate onward with and without S9 mix.
TOXICITY: A weak bacteriotoxic effect was occasionally observed depending on the strain and test conditions from about 2500 μg/plate onward.
MUTAGENICITY: An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system.
CONCLUSION: According to the results of the present study, the test material is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions chosen here.
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