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Diss Factsheets

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

Referenceopen allclose all

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.

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.