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EC number: 202-262-3 | CAS number: 93-61-8
- 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 publication were observed for test chemical. Test chemical was reviewed to determine the mutagenic nature of N-methylformanilide (93-61-8). The studies are as mentioned below:
Ames assay
In an Ames test, test chemical was considered to be not mutagenic in Salmonella typhimurium strains TA1335, TA1537, TA97, TA98 and TA100 with and without metabolic activation.
In vitro chromosomal abbreviation study
Test chemical was considered to be not mutagenic in the absence and presence of S9 activation system when evaluated with a chromosomal aberration test.
In vitro Mammalian gene mutation study
The test chemical in the concentration of 0, 0.5, 1.0, 2.5 or 5.0 mM did not show any evidence of gene toxicity when CHO cells were exposed to the test chemical in the presence of S9 metabolic activation system and hence does not 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:
- 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: Refer below principle
- Principles of method if other than guideline:
- Weight of evidence prepared from various publication mention below.
1,The preincubation modification of the Salmonella/mammalian microsome assay
2,To evaluate the mutagenic potential of test chemical in Salmonella Typhimurium TA98,TA 100,TA 1535 and TA 1537 by AMES test. - GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium, other: TA98,TA 100,TA 1535 and TA 1537
- Details on mammalian cell type (if applicable):
- not specified
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- no data
- Test concentrations with justification for top dose:
- Metabolic activation: Male Sprague-Dawley rats and male Syrian hamsters were routinely used for the preparation of the liver fractions.
1,Test Concentration: 0, 1.0, 3.3, 10.0, 33.0, 100 microgram/plate
2,0,1,3.3,10,33,100 and 333µg/plate - Vehicle / solvent:
- Vehicle: No data available
Positive controls: Yes, sodium
azide for TA1535 and TA 100,4-nitro-o-phenylenediaminef or TA98, and 9-aminoacridine
for TA97 and TA1537; 2-aminoanthracene was used with all strains with hamster and rat liver metabolic activation systems.
Three of the mutagens, 9-aminoacridine hydrochloride H20, 4-nitro-o-phenylenediamine, and tris( 1,3-dichloro-2-propyl phosphate, were positive controls which were sent, coded, to each laboratory.
Negative control: Yes, Potassium chloride
Solvent / vehicle control: Yes - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: S9 mix;4 nitro-O phenylenediamine (TA 98), Sodium azide (TA1535and TA 100) and 9-Aminoacridine(TA1537) +S9 mix; 2-Aminoanthracene(all strains)
- Details on test system and experimental conditions:
-
Details on test system and conditions
METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):
NUMBER OF REPLICATIONS: Triplicate
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:
OTHER: - Evaluation criteria:
- Evaluation criteria:
The criteria used for data evaluation were the same as those described previously
[Haworth et al, 19831, and are summarized as follows: 1) mutagenic response: a
dose-related, reproducible increase in the number of revertants over background,
even if the increase was less than twofold; 2) nomutagenic response: when no
increase in the number of revertants was elicited by the chemical; 3) questionable
response: when there was an absence of a clear-cut dose-related increase in revertants;
when the dose-related increases in the number of revertants were not reproducible; or when the response was of insufficient magnitude to support a determination of
mutagenicity. - 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:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA100, TA1535, TA98 and TA1537
- 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: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- In an Ames test, test chemical was considered to be not mutagenic in Salmonella typhimurium strains TA1335, TA1537, TA97, TA98 and TA100 with and without metabolic activation.
- Executive summary:
Data for the various publication were observed for test chemical. Test chemical was reviewed to determine the mutagenic nature of N-methylformanilide (93-61-8). The studies are as mentioned below:
In an Ames test, test chemical , in dose of 0, 1.0, 3.3, 10.0, 33.0, 100 microgram/plate was not mutagenic in Salmonella typhimurium strains TA1335, TA1537, TA97, TA98 and TA100 with and without metabolic activation.
Supported by other study. Genetic toxicity in vitro study was assessed for test chemical. For this purpose AMES test was performed .The test material was exposed to Salmonella typhimurium TA100, TA1535, TA98 and TA1537in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were 0, 1, 3.3,10,33,100 and 333µg/plate. No mutagenic effects were observed in all strains, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non-mutagenic in Salmonella typhimurium TA100, TA1535, TA98 and TA1537by AMES test. Hence the substance cannot be classified as gene mutant 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: Principle mentioned below
- Principles of method if other than guideline:
- Weight of evidence prepared from various studies mention below
1,In vitro mammalian chromosome aberration test was performed to evaluate the mutagenic nature of cinnamaldehyde
2,To evaluate the mutagenic potential of test chemical in Chinese hamster ovary cells by in vitro mammalian chromosome aberration test. - GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- Details on mammalian cell line
- Type and identity of media: Mc-Coy’s 5a medium supplemented with 10% fetal calf serum, L-glutamine and antibiotics.
- Properly maintained: No data available
- Periodically checked for Mycoplasma contamination: No data available
- Periodically checked for karyotype stability: No data available
- Periodically "cleansed" against high spontaneous background: No data available - Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- The S9 mix consisted of 15 pl/ml liver homogenate (from male Sprague-Dawley rats, induced with Aroclor 1254), 2.4 mg/ ml NADP, and 4.5 mg/ml isocitric acid in serum-free medium.
- Test concentrations with justification for top dose:
- 1,Without S9:
Trial 1: 6.02, 7.96, 10.21 µg/ ml
Trial 2: 6.4, 12.8, 18.3 µg/ ml
With S9:
Trial 1: 50.2, 74.8, 100.3 µg/ ml
2,-S9;0,6.4,12.8 and 18.3 µg/mL (Long duration)
0,6.02,7.96 and 10.21 µg/mL (short duration)
+S9; 0,50.2,174.8and 100.3 µg/mL - Vehicle / solvent:
- Water, dimethyl sulfoxide (DMSO), ethanol or acetone, in that order of preference. The exact vehicle used for the current chemical cannot be determined.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- triethylenemelamine
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: In medium
DURATION
- Preincubation period: No data available
- Exposure duration: With S9: 2 hrs
Without S9: Approx. 8-12 hrs
- Expression time (cells in growth medium): 8-12 hrs
- Selection time (if incubation with a selection agent): After 8-26 hrs, depending on cells ability to reach mitosis (as observed from a prior performed SCE assay)
- Fixation time (start of exposure up to fixation or harvest of cells): 8-12 hr after the beginning of treatment, later harvest times, e.g., 18-26 hr, were used to allow delayed cells to reach mitosis.
SELECTION AGENT (mutation assays): Geimsa stain
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: No data available
NUMBER OF CELLS EVALUATED: 100 cells
DETERMINATION OF CYTOTOXICITY
- Method: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy: Yes
- Determination of endoreplication: Yes, but were not included in the totals.
- Other: No data available
OTHER: No data available - Evaluation criteria:
- Chromosomal aberrations were noted, where cells were selected for scoring on the basis of good morphology and completeness of karyotype (21 ± 2 chromosomes).
All types of aberration was recorded separately. - Statistics:
- For chromosome aberrations, linear regression analysis of the percentage of cells with aberrations vs the log-dose was used as the test for trend. To examine absolute increases over control levels at each dose, a binomial sampling
assumption (as opposed to Poisson) was used, and the test was that described by Margolin et a1 [1983, pp 714-7151. The P values were adjusted by Dunnett’s method to take into account the multiple dose comparisons. For data analysis, we used the “total” aberration category, and the criterion for a positive response was that the
adjusted P value be < 0.05. - Species / strain:
- Chinese hamster Ovary (CHO)
- 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:
- Additional information on results
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data available
- Effects of osmolality: No data available
- Evaporation from medium: No data available
- Water solubility: No data available
- Precipitation: No data available
- Other confounding effects: No data available
RANGE-FINDING/SCREENING STUDIES: doses were chosen for the aberration test based on a preliminary test of cell survival 24 hr after treatment. Doses were based on observations of cell confluence and mitotic cell availability in the SCE test.
COMPARISON WITH HISTORICAL CONTROL DATA: No data available
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data available - Remarks on result:
- other: other: Cell line used
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Test chemical was considered to be not mutagenic in the absence and presence of S9 activation system when evaluated with a chromosomal aberration test.
- Executive summary:
Data for the various publication were observed for test chemical. Test chemical was reviewed to determine the mutagenic nature of N-methylformanilide (93-61-8). The studies are as mentioned below:
In an in vitro Mammalian cell gene mutation assay, the mutagenic effects of test substance was evaluated in a Chinese hamster V79 cell line. Cells were properly maintained in Dulbecco's MEM supplemented with 5% fetal calf serum (FCS), 100 U/ml penicillin G and 100 µg/ml streptomycin sulfate. Prior to cinnamaldehyde exposure, HGPRT-mutants were induced by methyl methanesulfonate (MMS),N-nitroso-N-methylurea (MNU), ethyl methanesulfonate (EMS) and UV light. Controls were also included in the experiment, and which were either left untreated or treated with cinnamaldehyde alone at 100mM. According to the results, cinnamaldehyde (50 or 100mM) did not show any mutagenic or toxic effects by itself and did not modify mutation frequency when given to cells simultaneously with chemical mutagens. Therefore, test substance is regarded as not mutagenic.
In an in vitro Mammalian cell gene mutation assay, the mutagenic effects of test substance was evaluated in a Chinese hamster V79 cell line. Cells were properly maintained in Dulbecco's MEM supplemented with 5% fetal calf serum (FCS), 100 U/ml penicillin G and 100 µg/ml streptomycin sulfate. Prior to test substance exposure, HGPRT-mutants were induced by methyl methanesulfonate (MMS),N-nitroso-N-methylurea (MNU), ethyl methanesulfonate (EMS) and UV light. Controls were also included in the experiment, and which were either left untreated or treated with test substance alone at 100mM. According to the results, cinnamaldehyde (50 or 100mM) did not show any mutagenic or toxic effects by itself and did not modify mutation frequency when given to cells simultaneously with chemical mutagens. Therefore, test substance is regarded as not mutagenic.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: Principle mentioned below
- Principles of method if other than guideline:
- Weight of evidence prepared from various publication mention below
1,The effects of cinnamaldehyde on the induction of HGPRT-mutants in the Chinese hamster V79 cell line. - GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- Weight of evidence prepared from various studies mention below
1,In vitro mammalian cell gene mutation assay - Target gene HGPRT
2,The purpose of this study was to assess toxic and genotoxic effects of the test chemicals on Chinese Hamster Ovary (CHO) cells by using several different in vitro-based assays, including genotoxicity tests based on the OECD Guideline No. 476 “In Vitro Mammalian Cell Gene Mutation Test”. - Species / strain / cell type:
- other: Chinese Hamster V79 cell line
- Details on mammalian cell type (if applicable):
- Details on mammalian cell line
- Type and identity of media: Dulbecco's MEM supplemented with 5% fetal calf serum
(FCS), 100 U/ml penicillin G and 100 µg/ml
streptomycin sulfate
- Properly maintained: Yes
- Periodically checked for Mycoplasma contamination: No data available
- Periodically checked for karyotype stability: No data available
- Periodically "cleansed" against high spontaneous background: No data available - Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- Cell line used: Chinese Hamster Ovary (CHO) cells
- Type and identity of media: Ham's F-12K (Kaighn's) Medium containing 2 mM L-Glutamine supplemented with 10% Fetal Bovine Serum and 1% Penicillin-Streptomycin (10,000 U/mL).
- Properly maintained: Yes
- Periodically checked for Mycoplasma contamination: Not applicable
- Periodically checked for karyotype stability: Not applicable - Metabolic activation:
- not specified
- Metabolic activation system:
- no data
- Test concentrations with justification for top dose:
- 1,50 or 100 microM
2,1./2. 0, 0.5, 1.0, 2.5 or 5.0 mM - Vehicle / solvent:
- Vehicle
- Vehicle(s)/solvent(s) used:
Solvent: Absolute ethyl alcohol
Vehicle: A maximum of 0.02% ethyl alcohol in Hank’s BSS (HBSS) buffered with Hepes.
- Justification for choice of solvent/vehicle: No data available - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: In medium
DURATION
- Preincubation period:
- Exposure duration:2-4 hrs
- Expression time (cells in growth medium): 7 days
- Selection time (if incubation with a selection agent):10 days
- Fixation time (start of exposure up to fixation or harvest of cells): 7 days
SELECTION AGENT (mutation assays): 6TG
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: 3-4
NUMBER OF CELLS EVALUATED: 5 × 105 cells/100-mm dish
For cell viability: 100 cells/60-mm dish
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Cell viability
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available
OTHER: No data available - Evaluation criteria:
- An increase in mutation frequency was observed
Classes of aberrations included simple (breaks and terminal deletions), complex (rearrangements and translocations), and other (pulverized cells, despiralized chromosomes, and cells containing 10 or more aberrations). - Statistics:
- Student's t-test with computer assistance.
- Species / strain:
- other: Chinese Hamster V79 cell line
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- Chinese hamster Ovary (CHO)
- 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:
- No data available
- Remarks on result:
- other: other: Cell line used
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
Test chemical failed to induce mutation in the Mammalian cell and is therefore regarded as not mutagenic.- Executive summary:
Data for the various publication were observed for test chemical. Test chemical was reviewed to determine the mutagenic nature of N-methylformanilide (93-61-8). The studies are as mentioned below:
In an in vitro Mammalian cell gene mutation assay, the mutagenic effects of test substance was evaluated in a Chinese hamster V79 cell line. Cells were properly maintained in Dulbecco's MEM supplemented with 5% fetal calf serum (FCS), 100 U/ml penicillin G and 100 µg/ml streptomycin sulfate. Prior to cinnamaldehyde exposure, HGPRT-mutants were induced by methyl methanesulfonate (MMS),N-nitroso-N-methylurea (MNU), ethyl methanesulfonate (EMS) and UV light. Controls were also included in the experiment, and which were either left untreated or treated with cinnamaldehyde alone at 100mM. According to the results, cinnamaldehyde (50 or 100mM) did not show any mutagenic or toxic effects by itself and did not modify mutation frequency when given to cells simultaneously with chemical mutagens. Therefore, test substance is regarded as not mutagenic.
In an in vitro Mammalian cell gene mutation assay, the mutagenic effects of test substance was evaluated in a Chinese hamster V79 cell line. Cells were properly maintained in Dulbecco's MEM supplemented with 5% fetal calf serum (FCS), 100 U/ml penicillin G and 100 µg/ml streptomycin sulfate. Prior to test substance exposure, HGPRT-mutants were induced by methyl methanesulfonate (MMS),N-nitroso-N-methylurea (MNU), ethyl methanesulfonate (EMS) and UV light. Controls were also included in the experiment, and which were either left untreated or treated with test substance alone at 100mM. According to the results, cinnamaldehyde (50 or 100mM) did not show any mutagenic or toxic effects by itself and did not modify mutation frequency when given to cells simultaneously with chemical mutagens. Therefore, test substance is regarded as not mutagenic.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Data for the various publication were observed for test chemical. Test chemical was reviewed to determine the mutagenic nature of N-methylformanilide (93-61-8). The studies are as mentioned below:
Ames assay
In an Ames test, test chemical , in dose of 0, 1.0, 3.3, 10.0, 33.0, 100 microgram/plate was not mutagenic in Salmonella typhimurium strains TA1335, TA1537, TA97, TA98 and TA100 with and without metabolic activation.
Supported by other study. Genetic toxicity in vitro study was assessed for test chemical. For this purpose AMES test was performed .The test material was exposed to Salmonella typhimurium TA100, TA1535, TA98 and TA1537in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were 0, 1, 3.3,10,33,100 and 333µg/plate. No mutagenic effects were observed in all strains, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non-mutagenic in Salmonella typhimurium TA100, TA1535, TA98 and TA1537by AMES test. Hence the substance cannot be classified as gene mutant in vitro.
In vitro chromosomal abbreviation study
Genetic toxicity in vitro study was assessed for test chemical. For this purpose in vitro mammalian chromosome aberration test was performed .The test material was exposed toChinese hamster ovary cells inthe presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were mention below
S9;0,6.4,12.8 and 18.3 µg/mL (Long duration)
0,6.02,7.96 and 10.21 µg/mL (short duration)
+S9; 0,50.2,174.8and 100.3 µg/mL
No chromosome aberration, Chromosome gaps and breaks were observed in the presence or absence of metabolic activation. Therefore test chemical was considered to be non-mutagenic inChinese hamster ovary cells byin vitro mammalian chromosome aberration test. Hence the substance cannot be classified as non -mutagenic in vitro.
In an in vitro mammalian chromosome aberration test, the mutagenic effect test substance was evaluated in cloned Chinese hamster ovary (CHO-W-B1) cells in the absence and presence of an in vitro metabolic activation system (S9 mix). Cells were cultured in Mc-Coy’s 5a medium supplemented with 10% fetal calf serum, L-glutamine and antibiotics. Cells were exposed to the test chemical for 2 hr in the presence of S9 or throughout the incubation period without S9. Cells were collected by mitotic shake-off. Slides were stained with Giemsa. A statistically weak positive result was observed in the first trial without S9, however, this was due to the lack of aberrations in the solvent control and a slight increase based on only 18 cells at the highest dose. When repeating of the test at higher doses, the results showed no evidence for aberration induction. Based on the results provided, testsubstance wasregarded to be not mutagenic in the absence and presence ofS9 activation system when evaluated with a chromosomal aberration test.
In vitro Mammalian gene mutation study
In an in vitro Mammalian cell gene mutation assay, the mutagenic effects of test substance was evaluated in a Chinese hamster V79 cell line. Cells were properly maintained in Dulbecco's MEM supplemented with 5% fetal calf serum (FCS), 100 U/ml penicillin G and 100 µg/ml streptomycin sulfate. Prior to cinnamaldehyde exposure, HGPRT-mutants were induced by methyl methanesulfonate (MMS),N-nitroso-N-methylurea (MNU), ethyl methanesulfonate (EMS) and UV light. Controls were also included in the experiment, and which were either left untreated or treated with cinnamaldehyde alone at 100mM. According to the results, cinnamaldehyde (50 or 100mM) did not show any mutagenic or toxic effects by itself and did not modify mutation frequency when given to cells simultaneously with chemical mutagens. Therefore, test substance is regarded as not mutagenic.
In an in vitro Mammalian cell gene mutation assay, the mutagenic effects of test substance was evaluated in a Chinese hamster V79 cell line. Cells were properly maintained in Dulbecco's MEM supplemented with 5% fetal calf serum (FCS), 100 U/ml penicillin G and 100 µg/ml streptomycin sulfate. Prior to test substance exposure, HGPRT-mutants were induced by methyl methanesulfonate (MMS),N-nitroso-N-methylurea (MNU), ethyl methanesulfonate (EMS) and UV light. Controls were also included in the experiment, and which were either left untreated or treated with test substance alone at 100mM. According to the results, cinnamaldehyde (50 or 100mM) did not show any mutagenic or toxic effects by itself and did not modify mutation frequency when given to cells simultaneously with chemical mutagens. Therefore, test substance is regarded as not mutagenic.
Based on the data summarized, and CLP criteria N-methylformanilide (93-61-8) does not likly to induce gene mutation .Hence it is not likely to be mutagenic in vitro.
Justification for classification or non-classification
Based on the data summarized, and CLP criteria N-methylformanilide (93-61-8) does not likly to induce gene mutation .Hence it is not likely to be mutagenic in vitro.
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