Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vivo
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 vivo micronucleus test was carried out in mouse bone marrow, to find out genetic effect of dimethyl sulphone (Methylsulfonylmethane).
GLP compliance:
no
Type of assay:
other: micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Details on test material
- Name of test material (as cited in study report): Methylsulfonylmethane
- Molecular formula (if other than submission substance): C2-H6-O2-S
- Molecular weight (if other than submission substance): 94.1334 g/mol
- Substance type: Organic
- Physical state: Solid
Purity: No data available
- Impurities (identity and concentrations): No data available

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle(s)/solvent(s) used: Carboxymethylcellulose
- Justification for choice of solvent/vehicle: No data available
- Concentration of test material in vehicle: No data available
- Amount of vehicle (if gavage or dermal): 0.5% w/v (vehicle control group)
- Type and concentration of dispersant aid (if powder): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available
Details on exposure:
No data available
Duration of treatment / exposure:
48 hr
Frequency of treatment:
Once
Post exposure period:
No data available
Doses / concentrationsopen allclose all
Dose / conc.:
1 250 other: mg/kg
Dose / conc.:
2 500 other: mg/kg
Dose / conc.:
5 000 other: mg/kg
No. of animals per sex per dose:
No data available
Control animals:
not specified
Positive control(s):
Positive controls: mitomycin C
- Justification for choice of positive control(s): No data available
- Route of administration: intra peritoneal (i.p)
- Doses / concentrations: 4 mg/kg

Examinations

Tissues and cell types examined:
bone marrow
Details of tissue and slide preparation:
No data available
Evaluation criteria:
No data available
Statistics:
No data available

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: non mutagenic
Additional information on results:
RESULTS OF RANGE-FINDING STUDY
- Dose range: No data available
- Solubility: No data available
- Clinical signs of toxicity in test animals: No data available
- Evidence of cytotoxicity in tissue analyzed: No data available
- Rationale for exposure: No data available
- Harvest times: No data available
- High dose with and without activation: No data available
- Other:

RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): No data available
- Induction of micronuclei (for Micronucleus assay): No data available
- Ratio of PCE/NCE (for Micronucleus assay): No data available
- Appropriateness of dose levels and route: No data available
- Statistical evaluation: No data available

Applicant's summary and conclusion

Conclusions:
The micronucleus assay results confirmed that test substance at doses up to 5000 mg/kg did not exhibit any genotoxicity in mouse bone marrow.
Executive summary:

The in vivo micronucleus test was carried out in mouse bone marrow, to find out genetic effect of test substance . Methylsulfonylmethane was administered to group of mice using an oral gavage at doses of 1250, 2500, 5000mg/kg. The vehicle control groups received carboxymethyl cellulose at an equivalent oral volume of 0.5% w/v, whereas the positive control group received an i.p. dose of mitomycin C at 4mg/kg. No significant difference in body weight was noted between test substance treated mice and the solvent control. The number of micronucleated polychromatic erythrocytes, where the frequency in the solvent control was 0.4±0.5, the frequency in the positive control was 12.2±1.2, which was significantly higher and the frequency after test substance treatment with 1250, 2500, 5000mg/kg was 0.1±0.5, 0.5±0.5 and 0.4±0.5 respectively. Therefore, the test substance treatment did not cause any change in the frequency of micronucleated polychromatic erythrocytes when compared with the solvent control. Consequently, the micronucleus assay results confirmed that test substance at doses up to 5000 mg/kg did not exhibit any genotoxicity in mouse bone marrow.