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EC number: 947-407-8 | 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
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 25 March 1987 to 11 April 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- no strain to detect cross linking included
- Principles of method if other than guideline:
- Ames assay was performed to determine the mutagenic nature of test chemical.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-methyl-1-phenyl-3-pyrazolidone
- EC Number:
- 220-180-6
- EC Name:
- 4-methyl-1-phenyl-3-pyrazolidone
- Cas Number:
- 2654-57-1
- Molecular formula:
- C10H12N2O
- IUPAC Name:
- 4-methyl-1-phenylpyrazolidin-3-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (IUPAC name): 4-Methyl-1-phenyl-3-pyrazolidone- Common name: 4-Methyl-1-phenylpyrazolidin-3-one- Molecular formula: C10H12N2O- Molecular weight: 176.218 g/mol- Smiles notation: N1(NC(=O)[C@@H](C1)C)c1ccccc1 - InChl: 1S/C10H12N2O/c1-8-7-12(11-10(8)13)9-5-3-2-4-6-9/h2-6,8H,7H2,1H3,(H,11,13)- Substance type: Organic- Physical state: white powder
Constituent 1
Method
- Target gene:
- histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 from aroclor 1254 induced rat livers
- Test concentrations with justification for top dose:
- dose range finding: 5, 50, 500 and 5000 ug/platemain assay (with independent repeat): 15, 50, 150, 500 and 1500 ug/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO - Justification for choice of solvent/vehicle: no data
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: aminoanthrocene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)- Cell density at seeding (if applicable):ca 1E07/mLDURATION- Preincubation period: NA- Exposure duration: 72 hours at 37 °CNUMBER OF REPLICATIONS: 3/concentration (2 independent assays)DETERMINATION OF CYTOTOXICITY- Method:reduced bacterial back ground lawn and precipitate.
- Rationale for test conditions:
- No data
- Evaluation criteria:
- A test item is considered as mutagenic if:- a significant and dose-related increase in the number of revertants occurs with sufficient reproducibility- the number of revertant colonies is at least twice as high
- Statistics:
- NA
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- 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:
- at and above 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- 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:
- at and above 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- 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:
- at and above 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS- Effects of pH: No data- Effects of osmolality: No data- Evaporation from medium: No data- Water solubility: No data- Precipitation: No data- Definition of acceptable cells for analysis: No data- Other confounding effects: No dataRANGE-FINDING/SCREENING STUDIES: dose range finding study was performed at dose levels of 5, 50, 500 and 5000 ug/plateCYTOKINESIS BLOCK (if used)- Distribution of mono-, bi- and multi-nucleated cells: No dataNUMBER OF CELLS WITH MICRONUCLEI- Number of cells for each treated and control culture: No data- Indication whether binucleate or mononucleate where appropriate: No dataHISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)- Positive historical control data: No data- Negative (solvent/vehicle) historical control data: No dataADDITIONAL INFORMATION ON CYTOTOXICITY:- Measurement of cytotoxicity used: No data- Other observations when applicable: No data
- Remarks on result:
- other: No mutagenic potential
Applicant's summary and conclusion
- Conclusions:
- Test chemical did not induce gene mutation in Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA1538 in the presence and absence of S9 metabolic activation system and hence it is not likely to be mutagenic in vitro.
- Executive summary:
Ames assay was performed to determine the mutagenic nature of test chemical . The study was performed using Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA1538 in the presence and absence of aroclor 1254 induced S9 metabolic activation system in the standard plate incorporation assay. A dose range finding study was performed at dose levels of 5, 50, 500 and 5000 ug/plate. On the basis of the results obtained from the preliminary study, the test chemical was dissolved in DMSO and used at dose level of 15, 50, 150, 500 and 1500 ug/plate for the main study. In two independent assays with and without metabolic activation no increase of the number of revertants was observed. Based on the observations made, test chemical did not induce gene mutation in Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA1538 in the presence and absence of S9 metabolic activation system and hence it is not likely to be mutagenic in vitro.
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