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EC number: 440-870-2 | CAS number: 1013-88-3
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study comparable to OECD Guideline 471 under GLP conditions with acceptable restrictions (E. coli WP2 or S. typhimurium TA102 missing)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- E. coli WP2 or S. typhimurium TA102 missing
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 440-870-2
- EC Name:
- -
- Cas Number:
- 1013-88-3
- Molecular formula:
- C13 H11 N
- IUPAC Name:
- C,C-Diphenylmethyleneimine
- Reference substance name:
- Benzophenone imine
- IUPAC Name:
- Benzophenone imine
- Details on test material:
- - Name of test material (as cited in study report): BPI (Benzophenone imine)
- Analytical purity: 94.8 %
- Lot/batch No.: 11/94, Container 13
- Physical state: light yellow liquid
- Storage condition of test material: refrigerator
- Stability under test conditions: The stability of the test substance throughout the study period has been proven by reanalysis. The stability of the test substance in the vehicle DMSO over a period of 4 hours and in water over a period of 1 hour was verified analytically.
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): BPI (Benzophenone imine)
- Analytical purity: 94.8 %
- Lot/batch No.: 11/94, Container 13
- Physical state: light yellow liquid
- Storage condition of test material: refrigerator
- Stability under test conditions: The stability of the test substance throughout the study period has been proven by reanalysis. The stability of the test substance in the vehicle DMSO over a period of 4 hours and in water over a period of 1 hour was verified analytically.
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix prepared from Aroclor 1254-induced Sprague Dawley rat livers
- Test concentrations with justification for top dose:
- 20 - 5000 µg/plate (standard plate test); 0.8 - 500 µg/plate (preincubation test)
- Vehicle / solvent:
- - Vehicle used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- with S9: 2.5 µg 2-aminoanthracene for all strains; without S9: 5 µg N-methyl-N'-nitro-N-nitrosoguanidine for strains TA100 and TA1535, 10 µg 4-nitro-o-phenylendiamine for strain TA98, 100 µg 9-aminoacridine chloride monohydrate for strain TA 1537.
- Positive control substance:
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: with S9: 2.5 µg 2-aminoanthracene for all strains; without S9: 10 µg 4-nitro-o-phenylendiamine for strain TA98.
- Details on test system and experimental conditions:
- Standard Plate Test
Test tubes containing 2 ml soft agar kept in a water bath at 45°C, and remaining components added in the following order:
0.1 ml test solution or vehicle
0.1 ml bacterial suspension
0.5 ml S-9 mix (in tests with metabolic activation) or 0 .5 ml phosphate buffer (in tests without metabolic activation).
After mixing, the samples are poured onto Vogel-Bonner agar plates.
Preincubation assay
0.1 ml test solution or vehicle, 0.1 ml bacterial suspension and 0 .5 ml S-9 mix are incubated at 37°C for the duration of 20 minutes. Subsequently, 2 ml of soft agar is added and, after mixing, the samples are poured onto the Vogel-Bonner agar plates.
Both Tests
In each experiment 3 test plates per dose or per control used; after incubation at 37°C for 48 hours in the dark, the bacterial colonies ( his+ revertants) are counted.
The titer was determined and in regularly measurements the strain characteristics were checked. Sterility control was performed. - Evaluation criteria:
- To be chracterized as positive, a substance has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results
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:
- A bacteriotoxic effect (reduced his background growth, decrease in the number of his+ revertants) was observed at doses > 500 µg/plate (standard plate test) or from about 20 - 100 µg/plate onward (preincubation test).
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect (reduced his background growth, decrease in the number of his+ revertants) was observed at doses > 500 µg/plate (standard plate test) or from about 20 - 100 µg/plate onward (preincubation test).
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect (reduced his background growth, decrease in the number of his+ revertants) was observed at doses > 500 µg/plate (standard plate test) or from about 20 - 100 µg/plate onward (preincubation test).
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect (reduced his background growth, decrease in the number of his+ revertants) was observed at doses > 500 µg/plate (standard plate test) or from about 20 - 100 µg/plate onward (preincubation test).
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test substance was found
Applicant's summary and conclusion
- Conclusions:
- The test substance is not mutagenic in the Ames test with and without metabolic activation under the experimental conditions chosen.
- Executive summary:
The test substance was tested for its mutagenic potential based on the ability to induce back mutations in selected loci in several strains of Salmonella typhimurium in the Ame.The study was conducted under GLP conditions and is comparable to OECD Guideline 471 with acceptable restrictions (E. coli strain WP2 or S. typhimurium strain TA102 missing).
Strains: TA 1535, TA 100, TA 1537, TA 98
Dose range: 20.0 µg -5,000 µg/plate (SPT), 0.8 µg -500 µg/plate (PIT)
Test conditions: Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (Aroclor induced rat liver 5-9mix).
Solubility: No precipitation of the test substance was found.
Toxicity: A bacteriotoxic effect was observedat doses > 500 pg/plate (SPT) or from about 20 µg -100 µg/plate onward (PIT).
Mutagenicity: An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system.
Conclusion: According to the results of the present study, the test substance is not mutagenic in the Ames test under the experimental conditions chosen here.
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