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EC number: 201-642-6 | CAS number: 85-91-6
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Data for the various test chemicals was reviewed to determine the mutagenic nature of Methyl 2-(methylamino)benzoate ( 85-91-6). The studies are as mentioned below:
AMES Assay
Test substance was considered to be non mutagenic in Salmonella typhimurium strains with and without metabolic activation system in the plate incorporation and preincubation method performed.
In vitro Mammalian cell gene mutation assay
In vitro chromosome aberration test, Test material did not induce gene mutation in Chinese hamster lungs cells in the presence and absence of S9and hence is not likely to classify as a gene mutant in vitro.
Link to relevant study records
- 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:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
- Qualifier:
- according to guideline
- Guideline:
- other: Data is from WHO Food additives series 56 study report available on JECFA - Monographs & Evaluations
- Principles of method if other than guideline:
- Gene toxicity in vitro study was performed for the test compound methyl N-methylanthranilate using S typhimurium strain TA98 and TA100
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 rat liver homogenate
- Test concentrations with justification for top dose:
- 3-5000 µg/plate
- Vehicle / solvent:
- No data
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Test was carried out both in direct plate assay and pre-incubation assay. - Evaluation criteria:
- An increase in the number of revertants was noted
- Statistics:
- No data
- Species / strain:
- S. typhimurium, other: TA98, TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the direct plate assay, cytotoxicity observed at 3330 and 5000 µg/plate (+/- S9) in both the strains.
In pre-incubation assay, cytotoxicity observed 333-5000 µg/plate (+/- S9) in both the strains except in TA98 at 333µg/plate +S9. - Remarks on result:
- other: No mutagenic effec were observed
- Conclusions:
- Test substance was considered to be non mutagenic in Salmonella typhimurium strains TA100 and TA98 with and without metabolic activation system in the plate incorporation and preincubation method performed.
- Executive summary:
Gene toxicity in vitro study was performed for the test compound methyl N-methylanthranilate using S typhimurium strain TA98 and TA100. Plate incorporation and preincubation assay was performed at dose levels of 3-5000 µg/plate. with and without S9 metabolic activation system. The given test substance Methyl-N-Methyl-anthranilate failed to induce mutation in Salmonella typhimurium strains TA100 and TA98 with and without metabolic activation system S9 in the plate incorporation and preincubation method performed. The test material Methyl-N-Methyl-anthranilate is therefore not likely to be classified as a gene toxicant in vitro.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Weight of evidence prepared from various studies mention below
To evaluate the mutagenic potential of test chemical in Chinese hamster lung(CHL)cells by in vitro mammalian chromosome aberration test.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- Not specified
- Species / strain / cell type:
- other: Chinese hamster lung(CHL)cells
- Details on mammalian cell type (if applicable):
- CHL / IU cells derived from Chinese hamster lungs obtained from Dainippon Pharmaceutical Co., Ltd. (September 2003, passage: 14th generation,
frozen: 17th) were used for the test within 4 weeks after thawing succession - Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver, induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- 1,-S9 mix (6 hr short-term treatment); 100, 125, 150, 175, 200 μg/mL
+S9 mix (6 hr short-term treatment); 200, 225, 250, 275, 300 μg/mL
-S9 mix (24 hr continuous treatment; main test); 50, 75, 100, 125, 150 μg/mL
-S9 mix (24 hr continuous treatment; additional test); 100, 110, 120, 130, 140, 150 μg/mL
2,-S9 mix (6 hr short-term treatment); 100, 125, 150, 175, 200 μg/mL
+S9 mix (6 hr short-term treatment); 200, 225, 250, 275, 300 μg/mL
-S9 mix (24 hr continuous treatment; main test); 50, 75, 100, 125, 150 μg/mL
-S9 mix (24 hr continuous treatment; additional test); 100, 110, 120, 130, 140, 150 μg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Isotonic sodium chloride solution
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Isotonic sodium chloride solution
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: -S9 mix, Mitomycin C +S9 mix, Benzo [a] pyrene
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 3 days
- Exposure duration: short-time treatment method :6h
continuous treatment method:24h
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
NUMBER OF CELLS EVALUATED: 200 metaphases were scored per experimental group.
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- Structural abnormalities such as breakage and exchange of chromosome type or chromosome type, presence and absence of gap, and ploidy The presence or absence of cells (polyploid) was observed. The gap was not included in structural abnormality. Also analyzed 200 groups of metaphase cells per group for structural abnormalities and ploidy cells.
- Species / strain:
- other: Chinese hamster lung (CHL/IU) cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- other: Chinese hamster lung (CHL/IU) cells
- 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
- Remarks on result:
- other: No mutagenic effect were observed
- Conclusions:
- In vitro chromosome aberration test, Test material did not induce gene mutation in Chinese hamster lungs cells in the presence and absence of S9and hence is not likely to classify as a gene mutant in vitro.
- Executive summary:
In vitro Mammalian cell gene mutation assay
In vitro chromosome aberration study was performed to determine the mutagenic nature of test material.SHE cells (5x105) in tertiary culture were plated into 75-cm2flasks, incubated overnight, and treatedat dose levels from 0, 0.8,3,8,30µMfor 24 h.The test chemical was dissolved in distilled, deionized water .SHE cells have the doubling time of 16 h. The cells were harvested with 0.1% trypsin for chromosome preparation. Three hours before harvest, Colcemid was administered at 0.2µg/ml and metaphase chromosomes were prepared. For determination of chromosome aberrations, 100 metaphases were scored per experimental group. Achromatic lesions greater than the width of the chromatid were scored as gaps unless there was displacement of the broken piece of chromatid. If there was displacement, they were scored as breaks. Also, the chromosome aberration assay was carried out in the presence of exogenous metabolic activation with rat liver post-mitochondrial supernatant (PMS), Cells (5x105) were plated on 100-mm dishes and after overnight incubation, they were treated with chemical agents for 3 h in a 5% PMS mixture.). Cells were washed twice with 5 ml PBS (-) and incubated with fresh medium for 18 h followed by chromosome preparations., Test material did not induce gene mutation inSyrian hamster embryo (SHE) cells inthe presence and absence ofmetabolic activation with rat liver post-mitochondrial supernatant (PMS)and hence is not likely to classify as a gene mutant in vitro.
In vitro chromosome aberration study was performed to determine the mutagenic nature of test material. CHL / IU cells derived from Chinese hamster lungs. 2 × 10 4 CHL / IU cells were seeded in a dish (6 cm in diameter) containing 5 mL of the culture solution and cultured in a 37 ° C. CO 2 incubator (5% CO 2) for 3 days. After the preculture, in the short-time treatment method, the test substance was treated for 6 hours in the presence and absence of S9 mix and then cultured for 18 hours in fresh culture medium. In the continuous treatment method, the test substance was continuously treated for 24 hours. The test substance was dissolved in a Physiological saline to prepare a stock solution, and then the stock solution was serially diluted with a solvent to prepare a test substance preparation solution of a 0,100,125,150,200 µg/mL concentration without S9 and 2,200,225,250,275,300 µg/mL with S9 in the short-time treatment method while 0,50,75,100,125,150 µg/mL concentration in In the continuous treatment method were used . The test substance preparation solution was added so as to be 10 % Volume of the culture solution in all tests. As a positive control group, benzo [a] pyrene was added at a concentration of 20 μg / mL in the presence of S 9 mix in a short time treatment method, and mitomycin C at a concentration of 0.1 μg / mL, and in continuous treatment, mitomycin C was set at a concentration of 0.05 μg / mL. Chromosome analysis based on structural abnormalities such as breakage and exchange of chromosome type or chromosome type, presence and absence of gap, and ploidy. The presence or absence of cells (polyploid) was observed. The gap was not included in structural abnormality. Also analyzed 200 groups of metaphase cells per group for structural abnormalities and ploidy cells. The appearance frequency of chromosomal structural abnormalities and polyploid cells was less than 5% in both the short treatment method S9 mix presence and in the absence of S9 mix and in the treatment group treated with continuous treatment method 24 hours. Hence test material did not induce gene mutation inChinese hamster lungs cells inthe presence and absence of S9and hence is not likely to classify as a gene mutant in vitro
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data for the various test chemicals was reviewed to determine the mutagenic nature of Methyl 2-(methylamino)benzoate ( 85-91-6). The studies are as mentioned below:
AMES Assay and DNA repair Assay
Gene toxicity in vitro study was performed for the test chemical using S typhimurium strain TA98 and TA100. Plate incorporation and preincubation assay was performed at dose levels of 3-5000 µg/plate with and without S9 metabolic activation system. The given test substance failed to induce mutation in Salmonella typhimurium strains TA100 and TA98 with and without metabolic activation system S9 in the plate incorporation and preincubation method performed. The test material is therefore not likely to be classified as a gene toxicant in vitro.
In the same study, Salmonella mutagenicity assay was performed to evaluate the mutagenic nature of the test chemical. Direct plate incorporation assay was performed at dose levels of 10 -3330 µg/plate. The given test substance failed to induce mutation in Salmonella typhimurium strains TA102, TA1535, TA1537 with and without metabolic activation system S9 in the plate incorporation at concentration of 10-3330 µg/plate. Therefore, the test chemical is not likely to classify as a gene mutant in vitro.
In the same study, another gene mutation toxicity study was performed to evaluate the mutagenic nature of the test chemical . Preincubation assay was performed at dose levels of 3 -1000 µg/plate. The given test substance Methyl-N-Methyl-anthranilate was found to be non-mutagenic in Salmonella typhimurium strains TA102, TA1535, TA1537 with and without S9 metabolic activation system in the preincubation assay performed at concentration of 3-1000 µg/plate. Thus the test chemical is not likely to classify as a gene mutant in vitro.
The hepatocyte/DNA repair test which measures unscheduled DNA synthesis (UDS) is known to be sensitive to various classes of DNA-reactive carcinogens and is regarded as a reliable short-term test for the detection of chemical carcinogens. The genotoxicity of test chemical, was examined by a DNA repair test with rat hepatocytes. The test was performed basically in accordance with the method of Williams et al. The test material was dissolved in DMSO and the positive control used was N-2-fluorenylacetamide. The hepatocytes were exposed to the test chemical for 20 hrs. At the end of incubation, the cultures were washed, and the coverslips were mounted on glass slides. The slides were dipped in Sakura NR-M2 photographic emulsion and exposed for 14 days. Autoradiographic grains were counted on a television screen (Olympus, type S) with a microscopic attachment. The test chemical was evaluated to be positive only when the mean net nuclear grain count was more than 5 grains above background and statistically greater than that of controls. The results of the hepatocyte/DNA repair test suggests that test chemical is negative for genotoxicity in vitro.
In vitro Mammalian cell gene mutation assay
In vitro chromosome aberration study was performed to determine the mutagenic nature of test material.SHE cells (5x105) in tertiary culture were plated into 75-cm2flasks, incubated overnight, and treatedat dose levels from 0, 0.8,3,8,30µMfor 24 h.The test chemical was dissolved in distilled, deionized water .SHE cells have the doubling time of 16 h. The cells were harvested with 0.1% trypsin for chromosome preparation. Three hours before harvest, Colcemid was administered at 0.2µg/ml and metaphase chromosomes were prepared. For determination of chromosome aberrations, 100 metaphases were scored per experimental group. Achromatic lesions greater than the width of the chromatid were scored as gaps unless there was displacement of the broken piece of chromatid. If there was displacement, they were scored as breaks. Also, the chromosome aberration assay was carried out in the presence of exogenous metabolic activation with rat liver post-mitochondrial supernatant (PMS), Cells (5x105) were plated on 100-mm dishes and after overnight incubation, they were treated with chemical agents for 3 h in a 5% PMS mixture.). Cells were washed twice with 5 ml PBS (-) and incubated with fresh medium for 18 h followed by chromosome preparations., Test material did not induce gene mutation inSyrian hamster embryo (SHE) cells inthe presence and absence of metabolic activation with rat liver post-mitochondrial supernatant (PMS)and hence is not likely to classify as a gene mutant in vitro.
In vitro chromosome aberration study was performed to determine the mutagenic nature of test material. CHL / IU cells derived from Chinese hamster lungs. 2 × 10 4 CHL / IU cells were seeded in a dish (6 cm in diameter) containing 5 mL of the culture solution and cultured in a 37 ° C. CO 2 incubator (5% CO 2) for 3 days. After the preculture, in the short-time treatment method, the test substance was treated for 6 hours in the presence and absence of S9 mix and then cultured for 18 hours in fresh culture medium. In the continuous treatment method, the test substance was continuously treated for 24 hours. The test substance was dissolved in a Physiological saline to prepare a stock solution, and then the stock solution was serially diluted with a solvent to prepare a test substance preparation solution of a 0,100,125,150,200 µg/mL concentration without S9 and 2,200,225,250,275,300 µg/mL with S9 in the short-time treatment method while 0, 50, 75,100,125,150 µg/mL concentration in In the continuous treatment method were used. The test substance preparation solution was added so as to be 10 % Volume of the culture solution in all tests. As a positive control group, benzo [a] pyrene was added at a concentration of 20 μg / mL in the presence of S 9 mix in a short time treatment method, and mitomycin C at a concentration of 0.1 μg / mL, and in continuous treatment, mitomycin C was set at a concentration of 0.05 μg / mL. Chromosome analysis based on structural abnormalities such as breakage and exchange of chromosome type or chromosome type, presence and absence of gap, and ploidy. The presence or absence of cells (polyploid) was observed. The gap was not included in structural abnormality. Also analyzed 200 groups of metaphase cells per group for structural abnormalities and ploidy cells. The appearance frequency of chromosomal structural abnormalities and polyploid cells was less than 5% in both the short treatment method S9 mix presence and in the absence of S9 mix and in the treatment group treated with continuous treatment method 24 hours. Hence test material did not induce gene mutation inChinese hamster lungs cells inthe presence and absence of S9and hence is not likely to classify as a gene mutant in vitro.
Based on the studies summarized, the test chemical Methyl 2-(methylamino)benzoate ( 85-91-6) is not likely to classify as gene mutant in vitro.
Justification for classification or non-classification
Based on the data summarized and CLP criteria , Methyl 2-(methylamino)benzoate ( 85-91-6)did not induce gene mutation .Hence it is not likely to be mutagenic in vitro.
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