Potassium iodate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames assay:

 

The test chemical did not induce gene mutation in Salmonella typhimurium and E.coli strains in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

 

In vitro micronucleus assay:

 

Genotoxic effects of the test chemical was evaluated in vitro using the cytokinesis-block micronucleus assay on CHO cells. The study was performed using CHO cells. The test chemical was dissolved in culture medum and used at dose level of 0.625, 1.25, 2.5, 5 and 10 mM. In preliminary cytotoxicity assays, CHO cells were exposed for 1 h to the test compound at concentrations ranging from 0.001 to 5 mg/ml. The cells were exposed for 3 h to concentrations of the test compounds of 0.625, 1.25, 2.5, 5 and 10 mM. Test compound and MMS (30 mg/ml) were dissolved the culture medium. Exponentially growing CHO-K1 cells were plated in a six-well plate on glass coverslips (1.5 X 105 cells/well) and cultured 24 h prior to compound treatment. Duplicate coverslips were established for each experiment, and at least two independent experiments were performed. The cells were exposed to the chemicals at different concentrations for 3 h in a FCS free medium. At the end of treatment, cells were washed twice with PBS before a 20 h incubation in fresh medium containing 10% of FCS and 3 mg/ml of cytochalasin B. Thereafter, cells were washed twice with PBS and allowed to recover for 1.5 h in 10% FCS fresh medium. Cells were fixed with cold methanol, stained with acridine orange (62.5 mg/ml) for 5 min and mounted in Sorensen buffer. Slides were coded and blindly examined under an epifluorescence microscope at 1000X magnification under oil immersion. Briefly, the cells should be binucleated (BN) with an intact nuclear membrane and should be situated within the same cytoplasmic boundary. MN should be morphologically identical to but smaller than nuclei, their diameter usually varied between 1/6th and 1/3rd of the mean diameter of the main nuclei. MN should be readily distinguished and not be linked to the main nuclei via nucleoplasmic bridges. Cells showing chromatin condensation or nuclear fragmentation with an intact cytoplasmic membrane were classified as apoptotic cells. One thousand (1000) binucleated cells were scored for each slide. The frequencies of BN, of BN with MN (MNBN) and of apoptotic cells (AP) were estimated. MMS (30 mg/ml), a well known alkylating agent was used as positive control. Cytotoxicity was measured by the BN cell ratio between treated and control slides. Based on the observations made, the test chemical did not induce any increase in the frequency of MNBN cells for doses ranging from 0.625 to 10 mM in the micronucleus assay in the CHO cell line and hence it is not liekly to classify as a gene mutant in vitro.

 

Link to relevant study records

Reference

Reference 1

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

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: Refer below principle

Principles of method if other than guideline:

WoE derived based on the experimental 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: TA97, TA98, TA100, TA102, TA104, and TA1535

Remarks:

1

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium, other: TA98, TA100, TA1537, TA1538

Remarks:

2

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

E. coli WP2 uvr A

Remarks:

2

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:

Metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver

Test concentrations with justification for top dose:

1. 0, 100, 333, 1000, 3333 or 10000 µg/plate
2. 20-5000 µg/plate

Vehicle / solvent:

1. No data
2. - Vehicle(s)/solvent(s) used: Water
- Justification for choice of solvent/vehicle: The test chemical was soluble in water

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

methylmethanesulfonate

mitomycin C

other: The positive control for metabolic activation with all strains was 2-aminoanthracene, and 2-aminoanthracene or sterigmatocystin was used for TA102.

Remarks:

1

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

Remarks:

2

Details on test system and experimental conditions:

1. 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): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: Triplicate

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data

OTHER: No data

2. No data

Rationale for test conditions:

No data

Evaluation criteria:

1. In this assay, a positive response is defined as a reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination. An equivocal response is defined as an increase in revertants that is not dose related, is not reproducible, or is not of sufficient magnitude to support a determination of mutagenicity. A negative response is obtained when no increase in revertant colonies is observed following chemical treatment. There is no minimum percentage or fold increase required for a chemical to be judged positive or weakly positive.

2. The plates were observed for number of revertants/plate

Statistics:

1. Mean, SEM

Species / strain:

S. typhimurium, other: TA97, TA98, TA100, TA102, TA104, and TA1535

Remarks:

1

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

Species / strain:

S. typhimurium, other: TA98, TA100, TA1537, TA1538

Remarks:

2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

No data

Remarks on result:

other: No mutagenic potential

Conclusions:

The test chemical did not induce gene mutation in Salmonella typhimurium and E.coli strains in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

Executive summary:

Data available for the various test chemicals was reviewed to determine the mutagenic nature of the test chemical. The studies are as mentioned below:

Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical. The study was performed usingSalmonella typhimurium strainsTA97, TA98, TA100, TA102, TA104, and TA1535 in the presence and absence of S9 metabolic activation system. The chemical was dissolved in suitable solvent and used at dose levels 0, 100, 333, 1000, 3333 or 10000µg/plate by the preincubation method. Concurrent solvent and positive controls were included in the study. The test chemicaldid not induce gene mutation in Salmonella typhimuriumTA97, TA98, TA100, TA102, TA104, and TA1535 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical. The study was performed usingSalmonella typhimurium strainsTA98, TA100, TA1537, TA1538, E.Coli WP2UvrA in the presence and absence of S9 metabolic activation system. The chemical was dissolved in suitable solvent and used at dose levels 0, 20-5000µg/plate. The test chemicaldid not induce gene mutation in Salmonella typhimuriumTA98, TA100, TA1537, TA1538, E.Coli WP2UvrA in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

Based on the observations made, the test chemical did not induce gene mutation in Salmonella typhimurium and E.coli strains in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

Reference 2

Endpoint:

in vitro cytogenicity / micronucleus study

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

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 is from peer reviewed publication

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Genotoxic effects of the test chemical was evaluated in vitro using the cytokinesis-block micronucleus assay on CHO cells

GLP compliance:

not specified

Type of assay:

in vitro mammalian cell micronucleus 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: The cell line was grown at 37 C in a humidified atmosphere at
5% CO2 in air, in HAM’S F12 medium with L-glutamine supplemented with 10% fetal calf serum (FCS), penicillin (50 UI/ml) and streptomycine (50 µg/ml). Cells were subcultured 24 h before treatment.
- Properly maintained: Yes
- Periodically checked for Mycoplasma contamination: No data
- Periodically checked for karyotype stability: No data
- Periodically "cleansed" against high spontaneous background: No data

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

not specified

Metabolic activation system:

no data

Test concentrations with justification for top dose:

0.625, 1.25, 2.5, 5 and 10 mM

Vehicle / solvent:

culture medium- Vehicle(s)/solvent(s) used: Culture medium
- Justification for choice of solvent/vehicle: The test chemical was soluble in culture medium

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

methylmethanesulfonate

Remarks:

MMS (30 µg/ml)

Details on test system and experimental conditions:

Cell culture procedure
Chinese hamster ovary (CHO-K1) cells were purchased from Eurobio (France). They were routinely maintained from stocks stored in liquid nitrogen. CHO cells were grown at 37 C in a humidified atmosphere at 5% CO2 in air, in HAM’S F12 medium with l-glutamine supplemented with 10% fetal calf serum (FCS), penicillin (50 UI/ml) and streptomycine (50 mg/ml). Cells were subcultured 24 h before treatment.

Cell treatment
In preliminary cytotoxicity assays, CHO cells were exposed for 1 h to the test compounds at concentrations ranging from 0.001 to 5 mg/ml.
In the alkaline comet assay and in the cytokinesisblock micronucleus assay, cells were exposed for 3 h to concentrations of the test compounds of 0.625, 1.25, 2.5,5 and 10 mM. Tests compounds and MMS (30 mg/ml) were dissolved the culture medium. Etoposide (0.5 mg/ml) was dissolved in DMSO.

METHOD OF APPLICATION: in medium
- Cell density at seeding (if applicable): 150000 cells/well

DURATION
- Preincubation period: No data
- Exposure duration: 3 hrs
- Expression time (cells in growth medium): 20 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data

SPINDLE INHIBITOR (cytogenetic assays): No data

STAIN (for cytogenetic assays): Acridine orange

NUMBER OF REPLICATIONS: Duplicate

METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: Cells were fixed with cold methanol, stained with acridine orange (62.5 mg/ml) for 5 min and mounted in Sorensen buffer. Slides were coded and blindly examined under an epifluorescence microscope at 1000X magnification under oil immersion.

NUMBER OF CELLS EVALUATED: One thousand (1000) binucleated cells were scored
for each slide.

NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): No data

CRITERIA FOR MICRONUCLEUS IDENTIFICATION: MN should be morphologically identical to but smaller than nuclei, their diameter usually varied between 1/6th and 1/3rd of the mean diameter of the main nuclei. MN should be readily distinguished and not be linked to the main nuclei via nucleoplasmic bridges. Cells showing chromatin condensation or nuclear fragmentation with an intact cytoplasmic membrane were classified as apoptotic cells.

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Yes, Cytotoxicity was measured by the Binucleate cell ratio between treated and control slides
- Any supplementary information relevant to cytotoxicity: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Methods, such as kinetochore antibody binding, to characterize whether micronuclei contain whole or fragmented chromosomes (if applicable): No data

- OTHER: No data

Rationale for test conditions:

No data

Evaluation criteria:

MN should be morphologically identical to but smaller than nuclei, their diameter usually varied between 1/6th and 1/3rd of the mean diameter of the main nuclei. MN should be readily distinguished and not be linked to the main nuclei via nucleoplasmic bridges. Cells showing chromatin condensation or nuclear fragmentation with an intact cytoplasmic membrane were classified as apoptotic cells.

Statistics:

In the cytokinesis-block micronucleus assay, data were expressed as the percentage of binucleated cells with micronuclei. Comparisons between control and treated cell cultures were made using ANOVA and Dunnett’s one sided test.

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

not specified

Genotoxicity:

negative

Remarks:

Potassium iodate did not induce any increase in the frequency of MNBN cells for doses ranging from 0.625 to 10 mM.

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Definition of acceptable cells for analysis: No data
- Other confounding effects: No data

RANGE-FINDING/SCREENING STUDIES: In preliminary cytotoxicity assays, CHO cells were
exposed for 1 h to the test compounds at concentrations ranging from 0.001 to 5 mg/ml.

CYTOKINESIS BLOCK (if used)
- Distribution of mono-, bi- and multi-nucleated cells: No data

NUMBER OF CELLS WITH MICRONUCLEI
- Number of cells for each treated and control culture: No data
- Indication whether binucleate or mononucleate where appropriate: No data

HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: No data
- Negative (solvent/vehicle) historical control data: No data

ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: No data
- Other observations when applicable: No data

Conclusions:

The test chemical did not induce any increase in the frequency of MNBN cells for doses ranging from 0.625 to 10 mM in the micronucleus assay in the CHO cell line and hence it is not liekly to classify as a gene mutant in vitro.

Executive summary:

Genotoxic effects of the test chemical was evaluated in vitro using the cytokinesis-block micronucleus assay on CHO cells. The study was performed using CHO cells. The test chemical was dissolved in culture medum and used at dose level of 0.625, 1.25, 2.5, 5 and 10 mM. In preliminary cytotoxicity assays, CHO cells were exposed for 1 h to the test compound at concentrations ranging from 0.001 to 5 mg/ml. The cells were exposed for 3 h to concentrations of the test compounds of 0.625, 1.25, 2.5, 5 and 10 mM. Test compound and MMS (30 mg/ml) were dissolved the culture medium. Exponentially growing CHO-K1 cells were plated in a six-well plate on glass coverslips (1.5 X 10⁵ cells/well) and cultured 24 h prior to compound treatment. Duplicate coverslips were established for each experiment, and at least two independent experiments were performed. The cells were exposed to the chemicals at different concentrations for 3 h in a FCS free medium. At the end of treatment, cells were washed twice with PBS before a 20 h incubation in fresh medium containing 10% of FCS and 3 mg/ml of cytochalasin B. Thereafter, cells were washed twice with PBS and allowed to recover for 1.5 h in 10% FCS fresh medium. Cells were fixed with cold methanol, stained with acridine orange (62.5 mg/ml) for 5 min and mounted in Sorensen buffer. Slides were coded and blindly examined under an epifluorescence microscope at 1000X magnification under oil immersion. Briefly, the cells should be binucleated (BN) with an intact nuclear membrane and should be situated within the same cytoplasmic boundary. MN should be morphologically identical to but smaller than nuclei, their diameter usually varied between 1/6th and 1/3rd of the mean diameter of the main nuclei. MN should be readily distinguished and not be linked to the main nuclei via nucleoplasmic bridges. Cells showing chromatin condensation or nuclear fragmentation with an intact cytoplasmic membrane were classified as apoptotic cells. One thousand (1000) binucleated cells were scored for each slide. The frequencies of BN, of BN with MN (MNBN) and of apoptotic cells (AP) were estimated. MMS (30 mg/ml), a well known alkylating agent was used as positive control. Cytotoxicity was measured by the BN cell ratio between treated and control slides. Based on the observations made, the test chemical did not induce any increase in the frequency of MNBN cells for doses ranging from 0.625 to 10 mM in the micronucleus assay in the CHO cell line and hence it is not liekly to classify as a gene mutant in vitro.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Data available for the target chemical and its various test chemicals was reviewed to determine the mutagenic nature. The studies are as mentioned below:

Ames assay:

 

Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical. The study was performed usingSalmonella typhimurium strainsTA97, TA98, TA100, TA102, TA104, and TA1535 in the presence and absence of S9 metabolic activation system. The chemical was dissolved in suitable solvent and used at dose levels 0, 100, 333, 1000, 3333 or 10000µg/plate by the preincubation method. Concurrent solvent and positive controls were included in the study. The test chemicaldid not induce gene mutation in Salmonella typhimuriumTA97, TA98, TA100, TA102, TA104, and TA1535 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

 

Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical. The study was performed usingSalmonella typhimurium strainsTA98, TA100, TA1537, TA1538, E.Coli WP2UvrA in the presence and absence of S9 metabolic activation system. The chemical was dissolved in suitable solvent and used at dose levels 0, 20-5000µg/plate. The test chemicaldid not induce gene mutation in Salmonella typhimuriumTA98, TA100, TA1537, TA1538, E.Coli WP2UvrA in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

 

In vitro micronucleus assay:

 

Genotoxic effects of the test chemical was evaluated in vitro using the cytokinesis-block micronucleus assay on CHO cells. The study was performed using CHO cells. The test chemical was dissolved in culture medum and used at dose level of 0.625, 1.25, 2.5, 5 and 10 mM. In preliminary cytotoxicity assays, CHO cells were exposed for 1 h to the test compound at concentrations ranging from 0.001 to 5 mg/ml. The cells were exposed for 3 h to concentrations of the test compounds of 0.625, 1.25, 2.5, 5 and 10 mM. Test compound and MMS (30 mg/ml) were dissolved the culture medium. Exponentially growing CHO-K1 cells were plated in a six-well plate on glass coverslips (1.5 X 105 cells/well) and cultured 24 h prior to compound treatment. Duplicate coverslips were established for each experiment, and at least two independent experiments were performed. The cells were exposed to the chemicals at different concentrations for 3 h in a FCS free medium. At the end of treatment, cells were washed twice with PBS before a 20 h incubation in fresh medium containing 10% of FCS and 3 mg/ml of cytochalasin B. Thereafter, cells were washed twice with PBS and allowed to recover for 1.5 h in 10% FCS fresh medium. Cells were fixed with cold methanol, stained with acridine orange (62.5 mg/ml) for 5 min and mounted in Sorensen buffer. Slides were coded and blindly examined under an epifluorescence microscope at 1000X magnification under oil immersion. Briefly, the cells should be binucleated (BN) with an intact nuclear membrane and should be situated within the same cytoplasmic boundary. MN should be morphologically identical to but smaller than nuclei, their diameter usually varied between 1/6th and 1/3rd of the mean diameter of the main nuclei. MN should be readily distinguished and not be linked to the main nuclei via nucleoplasmic bridges. Cells showing chromatin condensation or nuclear fragmentation with an intact cytoplasmic membrane were classified as apoptotic cells. One thousand (1000) binucleated cells were scored for each slide. The frequencies of BN, of BN with MN (MNBN) and of apoptotic cells (AP) were estimated. MMS (30 mg/ml), a well known alkylating agent was used as positive control. Cytotoxicity was measured by the BN cell ratio between treated and control slides. Based on the observations made, the test chemical did not induce any increase in the frequency of MNBN cells for doses ranging from 0.625 to 10 mM in the micronucleus assay in the CHO cell line and hence it is not liekly to classify as a gene mutant in vitro.

 

 

Comet assay:

 

Genotoxic effects of the test chemical was evaluated in vitro using the alkaline comet assay using CHO cells. The test chemical was dissolved in culture medium and used at dose level of 0.625, 1.25, 2.5, 5 and 10 mM. Cells were collected by trypsination,suspended in prewarmed low melting point (LMP) agarose (0.5% in PBS) and deposited on a conventional microscope slide (initially dipped in 1% agarose and dried) precoated with normal agarose (0.8% in PBS). Slides were put in a lysis solution (2.5 M NaCl, 0.1 M EDTA, 10 mM Tris pH10, 10% DMSO and 1% Triton X 100) for 1 h at about 5 C. DNA was allowed to unwind in electrophoresis buffer (0.3 M NaOH, 1 mM EDTA, pH13.6) for 40 min at room temperature. Slides were then placed into a horizontal electrophoresis tank and exposed to 0.7 V/cm (300 mA) for 24 min. After electrophoresis, slides were washed twice in neutralization buffer (0.4 M Tris, pH7.5) and dehydrated in ethanol for 5 min. After staining with ethidium bromide, 50 randomly selected cells per slide were submitted to image analysis. Olive tail moment was used to evaluate the extent of DNA damage in individual cells. Median values of OTM were calculated without taking HDC into account. Each dose was tested in duplicate and at least two independent assays were performed. Etoposide (0.5 mg/ml), a well known inhibitor of topoisomerase II inducing DNA double strand breaks, was used as positive control. In parallel to the assessment of DNA damage, cell viability was measured using the Trypan blue exclusion method. Cell viability was expressed as proportion of total cells. No primary DNA damage was observed after cell exposure to the test chemical. The slight increase in tail moment observed for the 10 mM potassium iodate concentration was not statistically significant from control. The test chemical did not induce DNA damage in CHO cells when tested at concentrations up to 10 mM in alkaline comet assay and hence it is not likely to classify as a gene mutant in vitro.

Based on the data available for the target and it various test chemicals, the test chemicals does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as gene mutant in vitro.

Justification for classification or non-classification

Based on the data available for the target and it various test chemicals, the test chemicals does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as gene mutant in vitro.