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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from peer-reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Evaluation of Genotoxicity on Plant-Derived Dietary Sulfur
Author:
LEE, YOON-IK
Year:
2006
Bibliographic source:
J. Microbial. Biotechnol.

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The in vitro chromosome aberration test was carried out using Chinese Hamster Lung (CHL) cells to evaluate genetic potential of substance dimethyl sulphone (Methylsulfonylmethane).
GLP compliance:
no
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
Chinese Hamster Lung (CHL) cells
Species / strain
Species / strain / cell type:
other: Chinese Hamster Lung (CHL) cells
Details on mammalian cell type (if applicable):
Details on mammalian cell line
- Type and identity of media: The cell were cultured in Eagles minimum essential medium (EMEM) supplemented with 10% fetal bovine serum. The cell were incubated in a 95% air and 5% CO₂ atmosphere at 37°C. The cell were plated at a density of 2.5ẋ10⁵ cells on 6cm plates and grown for 22h, and then colcemid (0.25g/ml) was added 2hr before harvest.
- 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
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9 fraction
Test concentrations with justification for top dose:
0, 5, 2.5, 1.25 mg/ml
Vehicle / solvent:
Vehicle
- Vehicle(s)/solvent(s) used: No data available
- Justification for choice of solvent/vehicle: No data available
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
methylmethanesulfonate
Details on test system and experimental conditions:
METHOD OF APPLICATION: plate incorporation

DURATION
- Preincubation period: No data available
- Exposure duration: 24hr
- Expression time (cells in growth medium): 22 hr
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): 24 hr

SELECTION AGENT (mutation assays): No data available

SPINDLE INHIBITOR (cytogenetic assays): No data available

STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: No data available

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: No data available

OTHER EXAMINATIONS
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
Rationale for test conditions:
No data
Evaluation criteria:
No data
Statistics:
No data

Results and discussion

Test results
Key result
Species / strain:
other: Chinese Hamster Lung (CHL) cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
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 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: No data available

COMPARISON WITH HISTORICAL CONTROL DATA: No data available

ADDITIONAL INFORMATION ON CYTOTOXICITY: No data available
Remarks on result:
other: no mutagenic potential

Applicant's summary and conclusion

Conclusions:
In the in vitro chromosome aberration test using Chinese Hamster Lung (CHL) cells, no abberation effects were seen.Therefore, the test substance is considered to be non mutagenic in Chinese Hamster Lung (CHL) cells.
Executive summary:

The in vitro chromosome aberration test was carried out using Chinese Hamster Lung (CHL) cells to evaluate the potential of test substance damaging chromosome. The cell were exposed to test substance at concentration 0, 5, 2.5, 1.25 mg/ml for 24 hr. Methylmethane sulfon ate (MMS)(0.02 mg/ml) and Benzo[a]pyrene (B[a]P) (0.02mg/ml) used as positive control substances. After treatment with test substance , no significant increase in the number of aberrant cells was observed. In presence or absence of S9 mix, the chromosome aberration produced by treatment with Methylsulfon ylmethane was less than 2 %. These results indicate that methylsulfonylmethane did not increase chromosome aberration as compared with the negative control. Therefore, the test substance is considered to be non genotoxic.