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EC number: 428-190-4 | CAS number: 68490-66-4 CUREZOL 2MA-OK
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 May to 06 Jun 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- EPA 712-C-98-247
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- EC Commission Directive 2000/32/EC Annex 4D-B.13/14. No. L 136/57
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United kingdom, London, England
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium) and trp operon (for E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male SD rats treated with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- First experiment: 5, 15, 50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation
Second experiment: 50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test material was not sufficiently soluble in distilled water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation assay); pre-incubation.
DURATION
- Preincubation period: when used during the second test: at 37 °C for 30 mins with shaking
- Exposure duration: 37 °C for 72 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: Method inspection of the background bacterial lawn - Rationale for test conditions:
- The test material caused no reduction in the growth of the background bacterial lawn at any dose level. The test material therefore, was tested up to the maximum recommended dose level of 5000 µg/plate
- Evaluation criteria:
- If exposure to a test substance produces a reproducible increase in revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle controls, with some evidence of a positive dose-response relationship, it is considered to exhibit mutagenic activity in this system. No statistical analysis is performed.
If exposure to a test substance does not produce a reproducible increase in revertant colony numbers, it is considered to show no evidence of mutagenic activity in this system. No statistical analysis is performed.
If the results obtained fail to satisfy the criteria for a clear "positive" or "negative' response, even after the additional testing, the test data may be subjected to analysis to determine the statistical significance of any increases in revertant colony numbers. The statistical analyses used are those described by Mahon et al (1989) and are usually followed by Dunnett's test, then if appropriate, by trend analysis. Biological importance should always be considered along with statistical significance. In general, treatment-associated increases in revertant colony numbers below two or three times the vehicle controls (as described above) are not considered biologically important. - Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- HISTORICAL CONTROL DATA (with ranges, means and standard deviation)
- Negative (solvent/vehicle) historical control data:
- Positive historical control data:
DMSO (Negative Control) historical control: mean revertant colony counts
[ TA100 ] [ TA1535 ] [ WP2 uvrA (pKM101) ] [ TA98 ] [ TA1537 ]
S9 mix - + - + - + - + - +
Mean 138 152 20 20 128 157 38 48 15 28
SD 25 27 5 4 27 29 6 9 5 8
Values 656 663 643 647 592 592 662 666 633 636
Min 70 56 9 5 60 78 17 17 6 9
Max 226 249 43 38 280 262 75 85 50 54
Positive Controls
[ TA100 ] [ TA1535 ] [ WP2 uvrA (pKM101) ] [ TA98 ] [ TA1537 ]
S9 mix - - + + - - + + - - + - - + - +
PC NaN3 NaN3 B(a)P AAN NaN3 NaN3 AAN AAN AF-2 NQO AAN 2NF 2NF B(a)P AAC B(a)P
µg/plate 0.5 2 5 5 0.5 2 2 5 0.05 2 10 1 2 5 50 5
Mean 571 950 755 1913 371 1093 160 290 917 776 699 460 430 495 848 246
SD 177 278 174 736 159 302 112 100 447 354 400 522 107 222 440 117
Values 750 270 746 273 748 264 744 263 51 10 57 757 275 1028 736 988
Min 208 425 212 424 49 325 40 52 268 272 130 112 178 93 73 64
Max 1534 2440 1373 4328 1130 2306 1145 952 2081 1262 1451 4280 792 1287 3307 2115
PC = Positive Control
NaN3 = Sodium azide
AF-2 = 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide
2NF = 2-Nitrofluorene
AAC = 9-Aminoacridine
B(a)P = Benzo(a)pyrene
AAN = 2-Aminoanthracene
NQO = 4-Nitroquinoline-1-oxide
Any other information on results incl. tables
Test Results from Experiments 1 and 2
EXPERIMENT 1 (Standard Plate Test, SPT) |
|||||
S9-Mix |
Without |
||||
Test Item (mg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA(pKM101) |
TA98 |
TA1537 |
|
VC |
169.3±30.0 |
28.0±1.0 |
146.7±25.0 |
33.7±3.8 |
11.0±1.0 |
5 |
182.0±5.3 |
19.0±3.6 |
159.3±25.1 |
33.0±5.3 |
12.3±4.9 |
15 |
216.7±70.6 |
11.7±3.8 |
159.7±10.1 |
31.0±13.2 |
12.3±3.2 |
50 |
170.7±20.8 |
21.0±7.9 |
196.3±118.6 |
32.3±5.1 |
13.7±2.1 |
150 |
128.0±14.0 |
19.7±3.2 |
163.7±48.6 |
31.7±17.6 |
18.3±1.5 |
500 |
150.0±14.2 |
20.0±1.7 |
142.0±24.9 |
35.7±3.1 |
12.3±0.6 |
1500 |
165.0±46.4 |
26.0±7.5 |
156.7±41.4 |
25.3±3.2 |
10.7±2.1 |
5000 |
159.0±18.7 |
19.3±7.8 |
195.7±55.1 |
34.0±10.6 |
10.0±3.6 |
PC (mg/plate) |
NaN3(2) |
NaN3(2) |
NQO (2) |
2NF (2) |
AAC (50) |
965.3±125.5 |
1428.0±25.5 |
2171.0±180.4 |
309.3±75.7 |
770.0±444.4 |
|
S9-Mix |
With |
||||
Test Item (mg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA(pKM101) |
TA98 |
TA1537 |
|
VC |
211.3±26.8 |
18.3±2.9 |
171.0±13.1 |
39.60±5.5 |
28.0±3.6 |
5 |
180.7±10.1 |
21.0±3.0 |
200.7±21.0 |
38.0±6.6 |
32.0±10.8 |
15 |
193.7±16.9 |
24.3±9.1 |
204.0±21.4 |
33.0±4.6 |
34.3±13.1 |
50 |
163.0±26.9 |
16.3±1.2 |
164.7±24.6 |
41.7±2.5 |
32.0±2.6 |
150 |
159.3±17.6 |
17.0±1.7 |
175.0±9.86 |
35.3±6.5 |
31.7±6.4 |
500 |
187.7±13.8 |
19.3±9.1 |
186.7±24.0 |
41.7±2.9 |
27.7±4.7 |
1500 |
201.7±6.8 |
18.3±6.4 |
166.0±22.1 |
47.7±3.5 |
19.7±3.8 |
5000 |
184.0±17.1 |
19.0±2.6 |
196.3±22.5 |
39.7±7.5 |
18.0±1.7 |
PC (mg/plate) |
AAN (5) |
AAN (5) |
AAN (10) |
B(a)P (5) |
B(a)P (5) |
2845.3±597.9 |
315.3±11.0 |
437±16.7 |
179.3±31.5 |
304±36.1 |
|
VC = Vehicle control; PC = Positive control
NaN3= Sodium azide
2NF = 2-Nitrofluorene
NQO = 4-Nitroquinoline-1-oxide
AAC = 9-Aminoacridine
AAN = 2-Aminoanthracene
B(a)P = Benzo(a)pyrene
EXPERIMENT 2 (Standard Plate Test with Incubation) |
|||||
S9-Mix |
Without |
||||
Test Item (mg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA(pKM101) |
TA98 |
TA1537 |
|
VC |
163.3±12.9 |
26.7±2.3 |
197.7±5.5 |
46.3±4.2 |
13.3±1.5 |
50 |
155.3±22.0 |
23.3±3.1 |
185.3±19.7 |
47.7±5.5 |
16.3±1.2 |
150 |
140.0±5.3 |
27.7±1.5 |
214.7±16.3 |
43.7±4.0 |
13.0±3.0 |
500 |
136.3±5.9 |
25.3±2.9 |
190.3±12.7 |
41.7±3.2 |
15.3±4.5 |
1500 |
173.0±1.7 |
24.7±2.3 |
132.0±31.0 |
40.7±3.2 |
11.7±1.5 |
5000 |
148.7±16.3 |
23.0±2.6 |
163.3±10.2 |
46.7±6.4 |
15.7±3.2 |
PC (mg/plate) |
NaN3(2) |
NaN3(2) |
NQO (2) |
2NF (2) |
AAC (50) |
1062.3±76.7 |
1128.3±54.3 |
2138.0±493.1 |
326.0±32.0 |
436.0±12.1 |
|
S9-Mix |
With |
||||
Test Item (mg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA(pKM101) |
TA98 |
TA1537 |
|
VC |
194.0±13.7 |
28.3±0.6 |
220.3±18.5 |
56.3±6.8 |
34.3±4.2 |
50 |
214.0±18.5 |
19.7±2.3 |
221.3±23.0 |
57.3±9.1 |
34.3±3.5 |
150 |
180.7±11.0 |
18.0±5.2 |
213.7±16.5 |
60.3±2.9 |
28.3±5.1 |
500 |
179.0±28.2 |
22.3±2.1 |
212.0±29.7 |
60.7±4.2 |
33.0±4.0 |
1500 |
205.0±12.3 |
23.0±1.7 |
233.3±44.5 |
52.0±11.5 |
27.7±1.5 |
5000 |
223.3±10.0 |
18.7±2.9 |
243.7±45.6 |
57.0±3.6 |
27.0±6.1 |
PC (mg/plate) |
AAN (5) |
AAN (5) |
AAN (10) |
B(a)P (5) |
B(a)P (5) |
2785.0±271.6 |
312.3±15.3 |
707.3±143.9 |
319.3±42.5 |
267.7±69.6 |
|
VC = Vehicle control; PC = Positive control
NaN3= Sodium azide
2NF = 2-Nitrofluorene
NQO = 4-Nitroquinoline-1-oxide
AAC = 9-Aminoacridine
AAN = 2-Aminoanthracene
B(a)P = Benzo(a)pyrene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
Negative (for mutation) with metabolic activation.
Negative (for mutation) without metabolic activation.
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