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EC number: 204-817-5 | CAS number: 126-98-7
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Methacrylonitrile
- EC Number:
- 204-817-5
- EC Name:
- Methacrylonitrile
- Cas Number:
- 126-98-7
- Molecular formula:
- C4H5N
- IUPAC Name:
- 2-methylprop-2-enenitrile
- Details on test material:
- - Name of test material (as cited in study report): 2-methyl-2-propenenitrile (MAN)
- Stability under test conditions: The lot used for the study has been confirmed to be stable during the study
- Storage condition of test material: Shield from the light at cool temperature
Constituent 1
Method
- Target gene:
- No data
Species / strain
- Species / strain / cell type:
- other: Chinese hamster lung(CHL/IU) cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Eagle's MEM media (Nissui Seiyaku, Japan) with 10% of calf serum (Cansera International, lot number of 2608311).
- Additional strain / cell type characteristics:
- other: No more than 10 th-subculture after thawing of the purchased culture (4th of subculture).
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and 5,6-Benzoflavone induced rat liver, S9
- Test concentrations with justification for top dose:
- - Zero, 0.17, 0.34, 0.67 mg/mL (short-term treatment for 6 hours) in the absence of metabolic activation
- Zero, 0.17, 0.34, 0.67 mg/mL (continuous treatment for 24 hours) in the absence of metabolic activation
- Zero, 0.068, 0.14, 0.27, 0.54 mg/mL short-term treatment for 6 hours) in the presence of metabolic activation - Vehicle / solvent:
- Distilled water (lot number K8H73, Ohtsuka Seiyaku Kojo, Japan).
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- With metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium.
DURATION
- Exposure duration:
Without S9 mix: 6 or 24 hours
With S9 mix: 6 hours.
- Incubation time: (If the exposure duration is 6 hours) 18 hours in culture in treatment-free media.
STAIN (for cytogenetic assays): 3% Giemsa solution (diluted with 1/15 M of phosphate buffer solution, pH of 6.8).
NUMBER OF REPLICATIONS: 2.
DETERMINATION OF CYTOTOXICITY
- Method: cell growth rate, mitotic index. Cell growth rate of less than 20% were excluded from further chromosome aberration analysis. Mitotic index of 0.5% and above were subjected for the determination of cytotoxicity of the test substance.
Cytotoxicity 20% and above
OTHER EXAMINATIONS:
- Determination of polyploidy: Yea.
- Other: Observation of morphologic abnormalities.
- Evaluation criteria:
- Biological evaluation of significance and dose-dependent analysis.
- Statistics:
- Fisher's exact test and Cochran-Armitage test.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: Chinese hamster lung(CHL/IU) cells
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 20 % at 0.54 mg/mL
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- other: Chinese hamster lung(CHL/IU) cells
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 87.5 % at 0.67 mg/mL (4 hours), 109 % at 0.67 mg/mL (24 hours)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- Cells with structural aberrations were increased dose dependently after short term treatment with metabolic activation (frequency: 7.5-62.0 %). Polyploidy did not show a dose-dependent increase but was significantly induced at 0.068 mg/mL and 0.14 mg/mL during short term treatment with metabolic activation.
- Remarks on result:
- other: strain/cell type: Chinese hamster lung(CHL/IU) cells
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Chromosome analysis in short-term treatment with S9 mix
|
Concentration of methacrylonitrile (mg/mL) |
Concentration of CPA μg/mL |
||||
Zero |
0.068 |
0.14 |
0.27 |
0.54 |
5 |
|
Number of cells analysed |
200 |
200 |
200 |
200 |
Tox |
200 |
TAG
|
5
|
19*
|
31*
|
129* |
Tox |
127*
|
2.5 % |
9.5 % |
15.5 % |
64.5 % |
- |
63.5 % |
|
TA
|
4
|
15*
|
30*
|
124*
|
Tox |
124*
|
2.0 % |
7.5 % |
15.0 % |
62.0 % |
- |
62.0 % |
|
Polyploid (%)
|
0.50 |
3.13* |
1.88* |
0.14 |
Tox |
0.13 |
Cell number (%) |
100.0 |
80.3 |
80.7 |
67.5 |
20.2 |
-
|
Mitotic Index (%) |
- |
- |
- |
1.6 |
Tox |
- |
TAG = total number of cells |
||||||
TA = total number of cells with aberration except gap |
||||||
* indicates p < 0.05 |
||||||
Tox = not examined because of cytotoxicity |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
Chromosome analysis showed that the test material induced morphologic abnormalities and polyploidy after 6 h exposure in the presence of metabolic activation.
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