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EC number: 444-340-1 | 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:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in compliance with OECD GLP (1997) regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- MV31 K-Salz
- IUPAC Name:
- MV31 K-Salz
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): MV31 K-Salz
- Substance type: Mono-constituent
- Physical state: Solid (Grey granules)
- Analytical purity: 88%
- Purity test date: 19 September 2000
- Lot/batch No.: Lot no. 1268147/1-1268154/1
- Expiration date of the lot/batch:31 December 2001
- Stability under test conditions: Guranteed for 4 hours
- Storage condition of test material: Darkness at approximately 20 C in a fume cupboard
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strain
- 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:
- Aroclor 1254 induced rat liver S9-mix
- Test concentrations with justification for top dose:
- 50, 160, 500, 1600 and 5000 ug/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Deionized water
- Justification for choice of solvent/vehicle: Test article solubility
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other:
- Remarks:
- Without S9: TA100 and TA1535: sodium azide, TA1537: 9-aminoacridine, TA98: 2-nitrofluorene, TA102: Mitomycin C. With S9: All strains: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation (two independent mutagenicity studies conducted)
DURATION
- Preincubation period: 20-30 minutes
- Exposure duration: 48 hours
- Expression time (cells in growth medium): Approx. 48.5 hours
- Selection time (if incubation with a selection agent): 48.5 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 48 hours
SELECTION AGENT (mutation assays): Histidine minimal agar
NUMBER OF CELLS EVALUATED: Colonies on all plates were counted after exposure.
DETERMINATION OF CYTOTOXICITY
- Method: Bacterial lawn thinning and reduction in the number of colonies - Evaluation criteria:
- A test compound is classified as mutagenic if it has either of the following effects: A) It produces at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn or B) it induces a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test compound at complete bacterial background lawn. If the test substance does not achieve either of the above criteria, it is considered to show no evidence of mutagenic activity in this system.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Thinning of bacterial lawns and reduction in the number of colonies was observed in all strains at 1600 or 5000 ug/plate in the presence or absence of S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY: Thinning of bacterial lawns and reduction in the number of colonies was observed in all strains at 1600 or 5000 ug/plate in the presence or absence of S9-mix
- 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
Thinning of bacterial lawns and reduction in the number of colonies was observed in all strains at 1600 or 5000 ug/plate in the presence or absence of S9-mix - Executive summary:
The mutagenic potential of the test article (grey granules, purity approx. 88 Fl.%, CASRN 496805-64-2, Lot: 1268147/1-1268154/1) was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in the presence and absence of metabolic activation (S9-mix: Aroclor 1254-induced rat liver). This study was performed in compliance with OECD GLP (1997) and the German Chemical Law (1999). The study method was based on OECD 471 (1997), US EPA OPPTS 870.5100 (1998), and EEC Directive 92/69 L383A, B.14 (1992). Two independent mutagenicity studies were conducted (one plate incorporation test and one preincubation test. The test article was prepared in deionized water just prior to administration to the cells. In each mutagenicity assay, the test article was tested at up to 5000 ug/plate in each strain in the presence and absence of S9-mix. Strain-specific positive controls were tested in parallel. Each treatment was performed in triplicate. Toxicity (thinning of bacterial lawns and reduction in the number of colonies) was observed in all strains at 1600 or 5000 ug/plate in the presence or absence of S9-mix. No increase in the number of revertants in any strain at any dose in the presence or absence of S9-mix. All criteria for a valid assay were met as described in the protocol. Under the conditions of this study, the test article is not mutagenic in the Bacterial Reverse Mutation Assay in the presence or absence of metabolic activation.
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