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EC number: 218-747-8 | CAS number: 2224-33-1
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 17 to July 2, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- A standard NTP (National Toxicology Program) protocol.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- not specified
- Type of assay:
- other: in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Butanone oxime
- EC Number:
- 202-496-6
- EC Name:
- Butanone oxime
- Cas Number:
- 96-29-7
- Molecular formula:
- C4H9NO
- IUPAC Name:
- butan-2-one oxime
- Details on test material:
- - Name of test material (as cited in study report): Methyl ethyl ketoxime
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (Aroclor 1254-induced male Sprague-Dawley rat liver S9)
- Test concentrations with justification for top dose:
- Without metabolic activation: 1873, 2497, 3727, 5000 µg/mL
With metabolic activation: 2513, 3750, 5000 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl Sulfoxide
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Dimethyl Sulfoxide)
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In the test without S9, cells were incubated in McCoy’s 5A medium with methyl ethyl ketoxime for 18 hours; Colcemid was added and incubation continued for 2 hours. The cells were then harvested by mitotic shake-off, fixed, and stained with Giemsa. For the test with S9, cells were treated with methyl ethyl ketoxime and S9 for 2 hours, after which the treatment medium was removed and the cells incubated for 10 hours in fresh medium, with Colcemid present for the final 2 hours. Cells were harvested in the same manner as for the treatment without S9. The harvest time for the test was based on the cell cycle information obtained in the SCE test; because some cytotoxicity and cell cycle delay were anticipated in the absence of S9, the incubation period was extended. Cells were selected for scoring on the basis of good morphology and completeness of karyotype (21 ± 2 chromosomes). All slides were scored blind and those from a single test were read by the same person. Up to 200 first-division metaphase cells were scored at each dose level. Classes of aberrations included simple (breaks and terminal deletions), complex (rearrangements and translocations), and other (pulverized cells, despiralized chromosomes, and cells containing 10 or more aberrations).
- Evaluation criteria:
- Chromosomal aberration data are presented as percentages of cells with aberrations. To arrive at a statistical call for a trial, analyses were conducted on both the dose response curve and individual dose points. For a single trial, a statistically significant (P>=0.05) difference for one dose point and a significant trend (P>=0.003) were considered weak evidence for a positive response; significant differences for two or more doses indicated the trial was positive. A positive trend test, in the absence of a statistically significant increase at any one dose resulted in an equivocal call. Ultimately, the trial calls were based on a consideration of the statistical analyses as well as the biological information available to the reviewers.
- Statistics:
- Significance of percent cells with aberrations tested by the linear regression trend test versus log of the dose. Analyses were conducted on both the dose response curve and individual dose points
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- (up to 5000 µg/mL)
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Results of Chromosome Aberration test:
Trial #:1 Activation: No Activation Date: 07/02/1986 Harvest Time: 20.0 hrs Trial Call: Negative |
|||||||||||||||
Dose (µg/mL) |
Total Cells Examined |
Total Aberrations |
Complex Aberrations |
Simple Aberrations |
Other Abs. |
||||||||||
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
||||
Abs. |
Per |
With |
Abs. |
Per |
With |
Abs. |
Per |
With |
Abs. |
Per |
With |
||||
Cell |
Abs. |
Cell |
Abs. |
Cell |
Abs. |
Cell |
Abs. |
||||||||
Vehicle Control |
Negative (Not Specified) |
200 |
2 |
0.010 |
1.0 |
1 |
0.005 |
0.5 |
1 |
0.005 |
0.5 |
0 |
0.000 |
0.0 |
|
Vehicle Control |
Dimethyl Sulfoxide |
200 |
5 |
0.025 |
2.5 |
1 |
0.005 |
0.5 |
4 |
0.020 |
2.0 |
0 |
0.000 |
0.0 |
|
Test Chemical
|
Methyl ethyl ketoxime
|
1873 |
200 |
2 |
0.010 |
1.0 |
0 |
0.000 |
0.0 |
2 |
0.010 |
1.0 |
0 |
0.000 |
0.0 |
2497 |
200 |
5 |
0.025 |
2.5 |
0 |
0.000 |
0.0 |
5 |
0.025 |
2.5 |
0 |
0.000 |
0.0 |
||
3727 |
200 |
1 |
0.005 |
0.5 |
1 |
0.005 |
0.5 |
0 |
0.000 |
0.0 |
0 |
0.000 |
0.0 |
||
5000 |
0 |
0 |
0.000 |
0.0 |
0 |
0.000 |
0.0 |
0 |
0.000 |
0.0 |
0 |
0.000 |
0.0 |
||
Positive Control |
Mitomycin-C |
0.05 |
200 |
31 |
0.155 |
12.5 |
16 |
0.080 |
7.5 |
15 |
0.075 |
6.0 |
0 |
0.000 |
0.0 |
0.08 |
25 |
9 |
0.360 |
36.0 |
4 |
0.160 |
16.0 |
5 |
0.200 |
20.0 |
0 |
0.000 |
0.0 |
||
Trend |
-1.211 |
0.069 |
-1.345 |
|
|||||||||||
Probability |
0.887 |
0.472 |
0.911 |
Trial #:2 Activation: No Activation Date: 06/17/1986 Harvest Time: 20.0 hrs Trial Call: Test Failure |
|||||||||||||||
Dose (µg/mL) |
Total Cells Examined |
Total Aberrations |
Complex Aberrations |
Simple Aberrations |
Other Abs. |
||||||||||
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
||||
Abs. |
Per |
With |
Abs. |
Per |
With |
Abs. |
Per |
With |
Abs. |
Per |
With |
||||
Cell |
Abs. |
Cell |
Abs. |
Cell |
Abs. |
Cell |
Abs. |
||||||||
Vehicle Control |
Dimethyl Sulfoxide |
|
200 |
5 |
0.025 |
2.0 |
0 |
0.000 |
0.0 |
5 |
0.025 |
2.0 |
0 |
0.000 |
0.0 |
Test Chemical |
Methyl ethyl ketoxime |
2500 |
200 |
7 |
0.035 |
3.5 |
0 |
0.000 |
0.0 |
7 |
0.035 |
3.5 |
0 |
0.000 |
0.0 |
Positive Control |
Mitomycin-C |
0.08 |
25 |
11 |
0.440 |
28.0 |
4 |
0.160 |
12.0 |
7 |
0.280 |
20.0 |
0 |
0.000 |
0.0 |
Trend |
0.000 |
|
0.000 |
|
0.000 |
|
|||||||||
Probability |
0.000 |
0.000 |
0.000 |
Trial #:1 Activation: Induced Rat Liver S9 Date: 06/17/1986 Harvest Time: 12.0 hrs Trial Call: Negative |
|||||||||||||||
Dose (µg/mL) |
Total Cells Examined |
Total Aberrations |
Complex Aberrations |
Simple Aberrations |
Other Abs. |
||||||||||
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
||||
Abs. |
Per |
With |
Abs. |
Per |
With |
Abs. |
Per |
With |
Abs. |
Per |
With |
||||
Cell |
Abs. |
Cell |
Abs. |
Cell |
Abs. |
Cell |
Abs. |
||||||||
Vehicle Control |
Negative (Not Specified) |
|
200 |
6 |
0.030 |
2.5 |
2 |
0.010 |
1.0 |
4 |
0.020 |
2.0 |
0 |
0.000 |
0.0 |
Vehicle Control |
Dimethyl Sulfoxide |
|
200 |
6 |
0.030 |
2.5 |
2 |
0.010 |
1.0 |
4 |
0.020 |
2.0 |
0 |
0.000 |
0.0 |
Test Chemical |
Methyl ethyl ketoxime |
2513 |
200 |
6 |
0.030 |
2.5 |
2 |
0.010 |
1.0 |
4 |
0.020 |
2.0 |
0 |
0.000 |
0.0 |
3750 |
200 |
8 |
0.040 |
3.0 |
4 |
0.020 |
2.0 |
4 |
0.020 |
1.5 |
0 |
0.000 |
0.0 |
||
5000 |
200 |
4 |
0.020 |
2.0 |
1 |
0.005 |
0.5 |
3 |
0.015 |
1.5 |
0 |
0.000 |
0.0 |
||
Positive Control |
Cyclophosphamide |
7.5 |
200 |
32 |
0.160 |
11.5 |
13 |
0.065 |
4.0 |
19 |
0.095 |
7.5 |
0 |
0.000 |
0.0 |
37.5 |
25 |
13 |
0.520 |
44.0 |
4 |
0.160 |
16.0 |
9 |
0.360 |
32.0 |
0 |
0.000 |
0.0 |
||
|
Trend |
|
-0.166 |
|
-0.063 |
|
-0.493 |
|
|||||||
Probability |
0.566 |
0.525 |
0.689 |
Applicant's summary and conclusion
- Conclusions:
- No increase in chromosomal aberrations was observed in cultured Chinese hamster ovary cells treated with up to 5000 μg/mL methyl ethyl ketoxime, with or without S9
- Executive summary:
A cytogenetic Chromosome aberration tests with cultured Chinese hamster ovary cells was performed on methyl ethyl ketoxime according to NTP's standard protocol (test method similar to OECD Guideline 473). Chinese hamster ovary cells were exposed to 2513, 3750, 5000 µg/mL test item with metabolic activation (Aroclor 1254-induced male Sprague-Dawley rat liver S9) and to 1873, 2497, 3727, 5000 µg/mL without metabolic activation for a harvest time of 20 and 12 hours respectively. Up to 200 first-division metaphase cells were scored at each dose level. Classes of aberrations included simple (breaks and terminal deletions), complex (rearrangements and translocations), and other (pulverized cells, despiralized chromosomes, and cells containing 10 or more aberrations). Negative and positive controls were performed satisfactorily. No increase in chromosomal aberrations was observed in cultured Chinese hamster ovary cells treated with up to 5000 μg/mL methyl ethyl ketoxime, with or without S9.
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