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EC number: 468-740-0 | CAS number: -
- 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:
- 31 May 2005 to 16 June 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- MTDID 3285
- IUPAC Name:
- MTDID 3285
- Details on test material:
- - Substance type: Light brown waxy chunks
- Physical state: Solid
- Analytical purity: Minimum 80%
- Lot/batch no.: Lot 30045
- Expiration date of the lot/batch: 01 June 2006
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Other: Molecular weight: 610; Stable at higher temperatures (max 50 degrees C for maximum of 30 to 60 hours).
Constituent 1
Method
- Target gene:
- histidine requiring Salmonella typhimurium bacterial strains resulting in histidine-independent strains and in tryptophan-requiring Escherichia coli bacterial strain resulting in a tryptophan-independent strain.
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and Escherichia coli WP2uvrA
- Additional strain / cell type characteristics:
- other: S.typhi strains are histidine dependant and E.coli strain is tryptophan dependant.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (5% and 10% v/v)
- Test concentrations with justification for top dose:
- 3, 10, 33, 100, 333, 1000, 3330 and 5000 micrograms/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulfoxide
- Justification for choice of solvent/vehicle: The test article completely dissolves in DMSO (when treated with ultrasonic waves)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- other: The solvent, DMSO, was used as a negative control
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2AA) was used as a positive control for all strains with metabolic activation. For further details see Remarks field.
- Remarks:
- For the strains without metabolic activation, sodium azide, 9-aminacridine, 2-nitrofluorene, methylmethanesulfonate and 4-nitroquinoline N-oxide were used as positive controls for strain TA1535, TA 1537, TA98, TA 100 and WP2uvrA, respectively.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION
- in agar (plate incorporation)
DURATION
- expression time (cells in growth medium): 48 hours
NUMBER OF CELLS EVALUATED:
- revertant colonies were counted manually if there were less than 40 coloneis present. If more than 40 colonies were present, these could be counted automatically with a Protos model 50000-colony counter.
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other - Evaluation criteria:
- A test article is considered negative in the test if A) the total number of revertants in any tester strain at any concentration is not greather than two times the solvent control value, with or without metabolic activiation. B) The negative response should be reproducible in at elast one independently repeated experiment.
A test article is consdiered mositive in the test is A) it indueced at least a 2-fold, dose related increase in the number of revertant with respect to the number induced by the solvent control in any of the tester strains, either with or without metabolic activiation. However, any mean palet count of elss that 20 is considered not to be biologically relevant. B) In case a postiive response will be repeated, the postiive response should be reproducible in at least one independently repeated experiment.
These criteria are not absolute and other modifying factos might enter into the final evaluation decision. - Statistics:
- only number of revertant colonies were noted, no formal hypothesis tested.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- In the first and second mutation assays, no increases in the number of revertants were observed upon treatment with the test article under all conditions tested.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- observed in all tester strains at concentrations at or above 333 micrgorams/plate
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: The test article was tested in the tester strains TA100 and WP2uvrA with concentrations of 3, 10, 33, 100, 333, 1000 and 5000 micrograms/plate in the absence and presence of 5% (v/v) S9-mix. In the dose range finding test, the test article was tested up to concentrations of 5000 micrograms/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. The test article precipitated on the plates at dose levels of 3330 and 5000 micrograms/plate. In tester strain TA100, toxicity was observed at dose levels of 333 micrgorams per plate and above in the absence and presence of S9-mix. In tester strain WP2uvrA, toxicity was observed at dose levels of 1000 micrograms/plate and upwards in the absence of S9-mix and 3330 and 5000 micrograms/plate in the presence of S9-mix. Based on the dose range finding test, the test article was tested in the first mutation assay at a concentration range of 3 to 333 micrograms/plate in absence of S9--mix and at a concentration range of 666 micrograms/plate in the presence of 5% (v/v) S9-mix in tester strains T1535, TA1537 and TA98. For the second mutation assay, strains TA1535, TA1537 and TA100 , concentrations of 3, 10, 33, 100 and 333 micrograms/plate were used without S9-mix. With S9-mix, 10, 33, 100, 333 and 666 micrograms/plate were tested. In the TA98 tester strain, 10, 33, 100, 333 and 666 micrograms per plate were used. In the WP2uvrA tester strain, 33, 100, 333, 1000 and 3330 micrograms/plate were used.
COMPARISON WITH HISTORICAL CONTROL DATA: The negative and strain specific positive control values were within the laboratory histroical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. - 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
Based on the results of this study, it is concluded that the test article is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
The mutagenic activity of the test article in the Salmonella typhimurium reverse mutation assay and the Escherichia coli reverse mutation assay was assessed. Histidine-requiring strains of Salmonella typhimurium (TA 1535, TA1536, TA100 and TA98) and tryptophan requiring strain of Escherichia coli (WP2uvrA) were used as the tester strains in this study. The test was performed in two independent experiments in the presence and absence of S9-mix. The study procedure was based on most recent OECD and EEC guidelines. The test substance was dissolved in dimethyl sulfoxide of spectroscopic quality.Based on the results of the dose range finding test, the test article was tested in the first mutation assay at a concentration range of 3 to 333 micrograms/plate in the absence of S9-mix and at a concentration range of 10 to 666 micrograms/plate in the presence of 5% S9 mix in tester strains TA1535, TA1537 and TA98. In an independent repeat of the assay with additional parameters, the test article was tested at a concentration range of 3 to 333 micrograms/plate in the absence of S9-mix in tester strains TA100, TA1535 and TA1537. In tester strain TA98, the test article was tested at concentration of 33 to 3330 micrograms/plate in the absence and presence of 10% S9-mix. The test article precipitated on the plates at the top dose of 3330 micrograms/plate. Cytotoxicity was observed in all tester strains. The test article did not induce a dose-related, two-fold increase in the number of revertant (His+) colonies in each of the four tester strains (TA 1535, TA1537, TA100 and TA98) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment. In this study, the negative and strain-specific positive control values were within our laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Based on the results of this study, it is concluded that the test article is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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