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EC number: 202-219-9 | CAS number: 93-11-8
- 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
Ames assay:
The test chemical did not induce mutation in the Salmonella typhimurium strains both in the presence and absence of S9 metabolic activation system and hence is not likely to be mutagenic under the conditions of this study.
In vitro mammalian chromosome aberration study:
The test chemical did not induce chromosome aberrations in the mammalian cell line in the presence or absence of S9 metabolic activation system and hence it is not mutagenic in the chromosome aberration study performed.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- 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
- Remarks:
- Experimental data from various test chemicals
- Justification for type of information:
- Data for the target chemical is summarized based on data from various test chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE for the target CAS is summarized based on data from various test chemicals.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, and TA 1538
- Remarks:
- 2
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 100, TA 1537, TA1538 and TA98
- Remarks:
- 3
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- 2. S9 liver homogenate metabolic activation
3. S-9 liver fractions were prepared from Aroclor-pretreated rats (Aroclor 1254, 500 mg/kg ip) and adjusted to 25 mg protein/ml - Test concentrations with justification for top dose:
- 2. 0, 50, 150, 500, 1500, and 5000 μg/plate
3. 5 doses of the test substance were used upto 3600 µg/plate - Vehicle / solvent:
- 2. - Vehicle(s)/solvent(s) used: A vehicle control was used.
3. - Vehicle(s)/solvent(s) used: DMSO/water
- Justification for choice of solvent/vehicle: DMSO was used as solvent for the test materials that were poorly soluble in water - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 4-nitro-o-phenylenediamine for TA1538
- Remarks:
- 2
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO / water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- Remarks:
- 3
- Details on test system and experimental conditions:
- 2. NUMBER OF REPLICATIONS:
- Number of cultures per concentration - triplicate
3. METHOD OF APPLICATION: Plate incorporation method
DURATION
- Preincubation period: No data available
- Exposure duration: 48 hr
- Expression time (cells in growth medium): 48 hr - Rationale for test conditions:
- No data
- Evaluation criteria:
- 2. If there were increase in the mutation frequency in any of the strains tested at any of the concentrations tested.
3. A reproducible, dose-related and at least two-fold elevation of the spontaneous revertant frequency. Agents producing reproducible, dose-related and significant (P≤ 0.01) but less than two-fold elevations were classified as marginally mutagenic under the experimental conditions. - Statistics:
- 2. No data
3. Statistical significance was determined according to the methods of Kastenbaum & Bowman (1970). - Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, and TA 1538
- Remarks:
- 2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 1535, TA 100, TA 1537, TA1538 and TA98
- Remarks:
- 3
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No data
- Remarks on result:
- other: No mutagenic potential
- Conclusions:
- The test chemical did not induce mutation in the Salmonella typhimurium strains both in the presence and absence of S9 metabolic activation system and hence is not likely to be mutagenic under the conditions of this study.
- Executive summary:
In different studies, the given test chemical has been investigated for the mutagenic nature. The studies are as mentioned below:
Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical by Ames assay in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538. Five dose levels (50, 150, 500, 1500, and 5000 μg/plate) were studied, in triplicate, with and without addition of S9 liver homogenate metabolic activation. Positive controls included N-ethyl-N-nitro-N-nitroguanidine for TA100 and TA1535; 9-aminoacridine for TA1537; 4-nitro-o-phenylenediamine for TA1538 and 4-nitroquinoline-1-oxide for TA98. A vehicle control was used, as well as a positive control with 2-aminoanthracene, which is mutagenic only with metabolic activation. The increase in the mutation frequency in any of the strains tested at any of the concentrations tested considered for the mutagenic potential of the test chemical. Test chemical was not toxic to any of the strains tested at any of the concentrations tested. It produced no significant increase in the mutation frequency in any of the strains tested at any of the concentrations tested. All of the positive controls produced marked increases in the mutation frequency, and the S9 liver homogenate metabolic activation was confirmed active with the additional positive control. Therefore, the given test chemical did not induce mutation in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
In another study, mutagenic nature of the test chemical was determined by using gene mutation toxicity study. The test was performed by plate incorporation method using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 with and without S9 metabolic activation system at 5 different doses upto 3600 µg/plate and the plates were incubated for 48 hrs. Agents producing reproducible, dose-related and significant (P≤ 0.01) but less than two-fold elevations were classified as marginally mutagenic under the experimental conditions. Statistical significance was determined according to the methods of Kastenbaum & Bowman (1970). The test chemical did not induce mutation in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
Thus, based on the above summarized studies on test chemical, it can be concluded that the given test chemical did not induce mutation in the Salmonella typhimurium strains both in the presence and absence of S9 metabolic activation system and hence is not likely to be mutagenic under the conditions of this study.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- 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
- Remarks:
- Experimental data from various test chemicals
- Justification for type of information:
- Data for the target chemical is summarized based on the various test chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE for the target CAS is summarized based on data from various test chemicals.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- No data
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Remarks:
- 5
- Details on mammalian cell type (if applicable):
- Details on mammalian cell line
- Type and identity of media: Mc-Coy’s 5a medium with 10% fetal calf serum, L-glutamine, and antibiotics - Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- other: Chinese hamster lung(CHL)cells
- Remarks:
- 6
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Chinese hamster lung derived fibroblast cell line (CHL).
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- 5. The S9 mix consisted of 15 µl/ml liverhomogenate (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.
6. Rat liver, induced with phenobarbital and 5,6-benzoflavone - Test concentrations with justification for top dose:
- 5. Without S9: 300-3000 µg/ml
With S9: 300-3000 µg/ml
6. -S9 mix(24hr continuous exposure): 0, 375, 750, 1500 µg/mL
-S9 mix(48hr continuous exposure): 0, 375, 750, 1500 µg/mL
-S9 mix(short-term exposure): 0, 375, 750, 1500µg/mL
+S9 mix(short-term exposure): 0, 375, 750, 1500 µg/mL - Vehicle / solvent:
- 5. - Vehicle(s)/solvent(s) used: Water, dimethyl sulfoxide (DMSO), ethanol, or Acetone (in the order of preference).
6. - Vehicle(s)/solvent(s) used: DMSO - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water, dimethyl sulfoxide (DMSO), ethanol, or Acetone (in the order of preference)
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- triethylenemelamine
- cyclophosphamide
- mitomycin C
- Remarks:
- 5
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Remarks:
- 6
- Details on test system and experimental conditions:
- 5. Details on test system and conditions
METHOD OF APPLICATION: in medium
DURATION
- Preincubation period:
- Exposure duration: With S9: 2 hrs
Without S9: Apprx. 8.5-9hrs
- Expression time (cells in growth medium):8.5-9hrs
- Selection time (if incubation with a selection agent):after 18-26 hrs
- Fixation time (start of exposure up to fixation or harvest of cells):8-12 hrafter the beginning of treatment.
SELECTION AGENT (mutation assays):Geimsa stain
NUMBER OF CELLS EVALUATED:100 cells
OTHER EXAMINATIONS:
- Determination of polyploidy:Yes
6. Details on test system and conditions
Cells were seeded on a multi-plate for cell culture, and the test substance solution was treated 3 days after the culture. In the case of the continuous treatment method, the treatment is carried out continuously for 24 or 48 hours, and in the short treatment method, after treatment for 6 hours in the presence of S9 mix (+ S 9 mix) or absence (-S 9 mix), fresh The medium was replaced with a culture medium, and the culture was continued for 18 hours.
After fixation of the cells with 10% neutral buffered formalin solution (Wako Pure Chemical Industries, Ltd.), the cells were stained with 0.1% crystal violet (Kanto Kagaku Co., Ltd.) aqueous solution for 10 minutes. An appropriate amount of pigment eluate (30% ethanol, 1% acetic acid aqueous solution) was added and allowed to stand for about 5 minutes to elute the dye, and the absorbance at 580 nm was measured. For each dose group, the ratio to the absorbance in the solvent control group, ie the cell viability was calculated.
SPINDLE INHIBITOR (cytogenetic assays): colcemid
NUMBER OF CELLS EVALUATED: 100 cells were evaluated.
OTHER EXAMINATIONS:
- Determination of polyploidy: Yes - Rationale for test conditions:
- No data
- Evaluation criteria:
- 5. Chromosomal aberrations were noted; Cells were selected for scoring on the basis of good morphology and completeness of karyotype (21 ± 2 chromosomes).
Classes of aberrations included simple (breaks and terminal deletions), complex (rearrangements and translocations), and other (pulverized chromosomes).Gaps and endo-reduplications were recorded but were not included in the totals. Aberrations were not scored in polyploidy cells but metaphases with 19-23 chromosomes were used (the modal number being 21).
6. The cells were observed for chromosomal gaps, chromatid breaks (ctb), chromosome breaks (csb), chromosome segments (csb), chromosome segments They were classified as structural anomalies of exchange (cte), chromosome exchange (cse) and others (oth). At the same time, the incidence of ploidy cells was recorded. - Statistics:
- 5. For chromosome aberrations, linear regression analysis of the percentage of cells with aberrations vs the log-dose was used as the test for trend. Toexamine absolute increases over control levels at each dose, a binomial sampling assumption was used. The P values were adjusted 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 theadjusted P value be < 0.05.
6. No data - Species / strain:
- Chinese hamster Ovary (CHO)
- Remarks:
- 5
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- other: Chinese hamster lung (CHL) cells
- Remarks:
- 6
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- 5. RANGE-FINDING/SCREENING STUDIES: doses were chosen for the aberration test based on a preliminary testof cell survival 24 hr after treatment. Doses were based on observations of cell confluence and mitotic cell availability in the SCE test.
6. No data - Remarks on result:
- other: No mutagenic potential
- Conclusions:
- The test chemical did not induce chromosome aberrations in the mammalian cell line in the presence or absence of S9 metabolic activation system and hence it is not mutagenic in the chromosome aberration study performed.
- Executive summary:
In different studies, the given test chemical has been investigated for the mutagenic nature. The studies are as mentioned below:
In-vitro mammalian chromosome aberration test was performed to evaluate the mutagenic nature of the test chemical. Cloned Chinese hamster ovary cells (CHO-W-B1) were cultured in Mc-Coy’s 5a medium with 10% fetal calf serum, L-glutamine, and antibiotics. Test was carried out with and without an in vitro metabolic activation system (S9 mix). The S9 mix consisted of 15µl/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. In without metabolic activation, the test chemical was left in culture until colcemid addition, whereas with activation the test chemical was added along with S9 mix for only 2 hr at the beginning of the test period. The doses used for the study were 300-3000 µg/ml with and without S9.
The test chemical did not induce chromosome aberrations in the Chinese hamster ovary cell line in the presence and absence of S9 metabolic activation system and hence it is not mutagenic in the chromosome aberration study performed.
In another genetic toxicity in vitro study, the given test chemical was assessed for mutagenic effects. For this purpose in vitro mammalian chromosome aberration test was performed according to Guidelines for Screening Mutagenicity Testing of Chemicals (Japan). The test material was exposed to Chinese hamster lung (CHL) cells in the 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 mix(24hr continuous exposure): 0, 375, 750, 1500 µg/mL; -S9 mix(48hr continuous exposure): 0, 375, 750, 1500 µg/mL; -S9 mix(short-term exposure): 0, 375, 750, 1500µg/mL; +S9 mix(short-term exposure): 0, 375, 750, 1500 µg/mL. No chromosomal abbreviation, gaps were observed in cells, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non-mutagenic in Chinese hamster lung (CHL) cells by in vitro mammalian chromosome aberration test. Hence, the substance cannot be classified as gene mutant in vitro.
Thus, based on the above summarized studies on test chemical, it can be concluded that the given test chemical did not induce chromosome aberrations in the mammalian cell line in the presence and absence of S9 metabolic activation system and hence it is not mutagenic in the chromosome aberration study performed.
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
Gene mutation in vitro:
Data available from various sources was reviewed to determine the mutagenic nature of the given test chemical. The studies are as mentioned below:
Ames assay:
Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical by Ames assay in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538. Five dose levels (50, 150, 500, 1500, and 5000 μg/plate) were studied, in triplicate, with and without addition of S9 liver homogenate metabolic activation. Positive controls included N-ethyl-N-nitro-N-nitroguanidine for TA100 and TA1535; 9-aminoacridine for TA1537; 4-nitro-o-phenylenediamine for TA1538 and 4-nitroquinoline-1-oxide for TA98. A vehicle control was used, as well as a positive control with 2-aminoanthracene, which is mutagenic only with metabolic activation. The increase in the mutation frequency in any of the strains tested at any of the concentrations tested considered for the mutagenic potential of the test chemical. Test chemical was not toxic to any of the strains tested at any of the concentrations tested. It produced no significant increase in the mutation frequency in any of the strains tested at any of the concentrations tested. All of the positive controls produced marked increases in the mutation frequency, and the S9 liver homogenate metabolic activation was confirmed active with the additional positive control. Therefore, the given test chemical did not induce mutation in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
In another study, mutagenic nature of the test chemical was determined by using gene mutation toxicity study. The test was performed by plate incorporation method using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 with and without S9 metabolic activation system at 5 different doses upto 3600 µg/plate and the plates were incubated for 48 hrs. Agents producing reproducible, dose-related and significant (P≤ 0.01) but less than two-fold elevations were classified as marginally mutagenic under the experimental conditions. Statistical significance was determined according to the methods of Kastenbaum & Bowman (1970). The test chemical did not induce mutation in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
Thus, based on the above summarized studies on test chemical, it can be concluded that the given test chemical did not induce mutation in the Salmonella typhimurium strains both in the presence and absence of S9 metabolic activation system and hence is not likely to be mutagenic under the conditions of this study.
In vitro mammalian chromosome aberration study:
In-vitro mammalian chromosome aberration test was performed to evaluate the mutagenic nature of the test chemical. Cloned Chinese hamster ovary cells (CHO-W-B1) were cultured in Mc-Coy’s 5a medium with 10% fetal calf serum, L-glutamine, and antibiotics. Test was carried out with and without an in vitro metabolic activation system (S9 mix). The S9 mix consisted of 15µl/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. In without metabolic activation, the test chemical was left in culture until colcemid addition, whereas with activation the test chemical was added along with S9 mix for only 2 hr at the beginning of the test period. The doses used for the study were 300-3000 µg/ml with and without S9.
The test chemical did not induce chromosome aberrations in the Chinese hamster ovary cell line in the presence and absence of S9 metabolic activation system and hence it is not mutagenic in the chromosome aberration study performed.
In another genetic toxicity in vitro study, the given test chemical was assessed for mutagenic effects. For this purpose in vitro mammalian chromosome aberration test was performed according to Guidelines for Screening Mutagenicity Testing of Chemicals (Japan). The test material was exposed to Chinese hamster lung (CHL) cells in the 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 mix(24hr continuous exposure): 0, 375, 750, 1500 µg/mL; -S9 mix(48hr continuous exposure): 0, 375, 750, 1500 µg/mL; -S9 mix(short-term exposure): 0, 375, 750, 1500µg/mL; +S9 mix(short-term exposure): 0, 375, 750, 1500 µg/mL. No chromosomal abbreviation, gaps were observed in cells, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non-mutagenic in Chinese hamster lung (CHL) cells by in vitro mammalian chromosome aberration test. Hence, the substance cannot be classified as gene mutant in vitro.
Thus, based on the above summarized studies on test chemical, it can be concluded that the given test chemical did not induce chromosome aberrations in the mammalian cell line in the presence and absence of S9 metabolic activation system and hence it is not mutagenic in the chromosome aberration study performed.
Justification for classification or non-classification
Based on the data available and applying weight of evidence approach, the given test chemical does not exhibit gene mutation in vitro by Ames assay and In vitro mammalian chromosome aberration study. Hence, the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.
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