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EC number: 217-110-1 | CAS number: 1742-95-6
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from J check
Data source
Reference
- Reference Type:
- other: J check
- Title:
- Reverse Mutation Test of Phthalimide on Bacteria
- Author:
- Authorities of The Law, Ministry of Health, Labour and Welfare, Ministry Of Economy, Trade and Industry, and Ministry of the Environment
- Year:
- 2 016
- Bibliographic source:
- National Institute of Technology and Evaluation, 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Bacterial reverse mutation assay was performed for the test chemical phthalimide using Salmonella typhimurium strain TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Pthalimide
- IUPAC Name:
- Pthalimide
- Reference substance name:
- Phthalimide
- EC Number:
- 201-603-3
- EC Name:
- Phthalimide
- Cas Number:
- 85-41-6
- IUPAC Name:
- 1H-isoindole-1,3(2H)-dione
- Details on test material:
- - Name of test material: Pthalimide
- Molecular formula: C8H5NO2
- Molecular weight: 147.133 g/mol
- Substance type: Organic
- Physical state: White powder
- Purity: 99.9%
- Impurities (identity and concentrations): 0.01%
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine for Salmonella typhimurium and Tryptophan for E. coli
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:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applcable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0, 313, 625, 1250, 2500 or 5000 μg / plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data available
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2- (2-furyl) -3- (5-nitro-2-furyl) acrylamide, 2-amino-anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: Duplicate test was performed with 3 plates/dose level
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: No data - Evaluation criteria:
- Twice the number of revertant colonies as compared to the control was judged to be a positive result.
- Statistics:
- No data
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:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- 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: the test plates were observed for precipitation
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: Dose range finding study was performed at dose levels of 5000, 1250, 313, 78.1, 19.5, 4.88, 1.22 μg / plate. No mutagenic activity was noted in the dosed levels.
COMPARISON WITH HISTORICAL CONTROL DATA: No data - 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 with and without
The test compound pthalimide failed to induce mutation in the Salmonella typhimurium strain TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA with and without S9 mix and hence is negative for gene mutation in vitro. - Executive summary:
Bacterial reverse mutation assay was performed for the test chemical phthalimide using Salmonella typhimurium strain TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA. The study was performed using the preincubation protocol at dose levels of 0, 313, 625, 1250, 2500 or 5000 μg / plate with in incubation period of 48 hrs in the presence and absence of S9 mix.Dose range finding study was performed at dose levels of 5000, 1250, 313, 78.1, 19.5, 4.88, 1.22 μg / plate. No mutagenic response was noted for the test compound in the preliminary dose range finding study and the main study performed.
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