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EC number: 279-256-2 | CAS number: 79771-28-1
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Everzol SB26 was not mutagenic in the reverse mutation analysis of Salmonella typhimurium up to 5mg/plate in the absence and presence of S9 metabolic activation (OECD TG471).
Everzol SB26 was negative effect under the condition of in vitro mammalian chromosome aberration test (OECD TG473).
Everzol SB26was negative effect under the condition of in vitro mammalian cell gene mutation test (OECD TG476).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 22, 2016 to December 09, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-Aminoanthracene
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- According to OECD 471 test method, Everzol SB26 was not mutagenic in the reverse mutation analysis of Salmonella typhimurium up to 5 mg/plate.
- Executive summary:
This test using the procedures outlined in the SuperLub Study Plan for M62-151100132001EN which is based on the SOP for the OECD 471 (SOPF-203) and OECD 471 (OECD, 1997). The results of this OECD 471 test for Everzol SB26 show that test validity criteria was met.
Based on the preliminary assay results, 5mg/platewas set as the highest dose in this study. In the mutagenicity assay, five doses of Everzol SB26 at 0.3125, 0.625, 1.25, 2.5 and 5 mg/plate, concurrent negative and strain-specific positive controls were tested in tester strains TA98, TA100, TA102, TA1535 and TA1537 in triplicate with or without S9 Mix activation.
In the range-finding test of the Everzol SB26, no toxicity was observed in all five tester strains up to 5mg/plate in the absence and presence of metabolite activations. Results showed that Everzol SB26 did not increase the number of revertants in all five tester strains TA98, TA100, TA102, TA1535 and TA1537 up to 5mg/plate either in the absence or in the presence of metabolite activation.
Based on the data obtained from this study, it was concluded that under the test condition, Everzol SB26 was not mutagenic in the reverse mutation analysis of Salmonella typhimurium up to 5mg/plate in the absence and presence of S9 metabolic activation.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From December 02, 2015 to December 14, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell micronucleus test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Remarks:
- CHO-K1
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- other: cyclophosphamide monohydrate
- Species / strain:
- Chinese hamster Ovary (CHO)
- Remarks:
- CHO-K1
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- According to OECD 473 test method, Everzol SB26 was negative effect under the condition of in vitro mammalian chromosome aberration test.
- Executive summary:
This test using the procedures outlined in the SuperLub Study Plan for M62-151100133001EN which is based on the SOP for the OECD 473 (SOPF-207) and OECD 473 (OECD, 2014). The results of this OECD 473 test for Everzol SB26 show that test validity criteria was met.
Based on the results of the cell viability test, 2.0mg/mL was set as the highest dose in this study. In the chromosome aberration test, three doses of Everzol SB26 at 0.5, 1.0 and 2.0 mg/mL, negative and positive controls were tested in triplicate with or without S9 Mix. The cell proportion with abnormal chromosome was lower than 3% for all test groups in the absence and presence of S9 Mix. Based on the data obtained from this study, it was concluded that under the test condition, Everzol SB26 was negative effect in mammalian chromosome aberration test (in vitro).
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 19, 2016 to December 30, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell micronucleus test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Remarks:
- CHO-K1
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- benzo(a)pyrene
- Species / strain:
- Chinese hamster Ovary (CHO)
- Remarks:
- CHO-K1
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- According to OECD 476 test method, Everzol SB26 was negative effect under the condition of in vitro mammalian cell gene mutation test.
- Executive summary:
This test using the procedures outlined in the SuperLub Study Plan for M62-151100141001EN which is based on the SOP for the OECD 476 (SOPF-240) and OECD 476 (OECD, 2015). The results of this OECD 476 test for Everzol SB26 show that test validity criteria was met.
Based on the results of the cell viability test, 2.0 mg/mL was set as the highest dose in this study. In the gene mutation test, four doses of Everzol SB26 at 0.25, 0.5, 1.0 and 2.0mg/mL, negative and positive controls were tested in five repetitions with or without S9 Mix. The mutation frequency was no significantly different from the negative control group for all test groups in the absence and presence of S9 Mix. Based on the data obtained from this study, it was concluded that under the test condition, Everzol SB26 was negative effect in mammalian cell gene mutation test (in vitro).
Referenceopen allclose all
Table 1. Characteristics of five Salmonella typhimurium strains
Test strain |
Histidine requirement |
uvrB mutation |
rfa mutation |
Ampicillin resistance |
TA98 |
+ |
+ |
+ |
+ |
TA100 |
+ |
+ |
+ |
+ |
TA102 |
+ |
ϴ |
+ |
+ |
TA1535 |
+ |
+ |
+ |
ϴ |
TA1537 |
+ |
+ |
+ |
ϴ |
+ means had the characteristic; ϴ means did not have the characteristic
Table 2. Toxicity of the test article of Salmonella typhimurium TA100
Group |
Test article (mg/plate) |
Reverse mutant colony number (CFU/plate) |
With S9 Mix |
Negative control group |
200 |
Positive control groupa |
1234 |
|
Test group |
|
|
5 |
177 |
|
2.5 |
164 |
|
1.25 |
212 |
|
0.625 |
191 |
|
0.3125 |
205 |
|
Without S9 Mix |
Negative control group |
171 |
Positive control group |
770 |
|
Test group |
|
|
5 |
142 |
|
2.5 |
137 |
|
1.25 |
131 |
|
0.625 |
138 |
|
0.3125 |
171 |
a Positive control group: With S9 Mix: 2-Aminoanthracene (4.0μg/plate).
Without S9 Mix: Sodium azide (5μg/plate).
Table 3. Reverse mutation test of Salmonella typhimurium TA98
Group |
Test article (mg/plate) |
Reverse mutant colony number (CFU/plate) |
Average of coloniesa |
||
1 |
2 |
3 |
|||
With S9 Mix |
Negative control group |
53 |
29 |
38 |
40 ± 12 |
Positive control groupb |
234 |
226 |
218 |
226 ± 8* |
|
Test group |
|
|
|
|
|
5 |
31 |
28 |
35 |
31 ± 4 |
|
2.5 |
28 |
30 |
34 |
31 ± 3 |
|
1.25 |
35 |
31 |
31 |
32 ± 2 |
|
0.625 |
40 |
35 |
41 |
39 ± 3 |
|
0.3125 |
57 |
46 |
42 |
48 ± 8 |
|
Without S9 Mix |
Negative control group |
31 |
40 |
23 |
31 ± 9 |
Positive control group |
283 |
257 |
228 |
256 ± 28* |
|
Test group |
|
|
|
|
|
5 |
27 |
25 |
28 |
27 ± 2 |
|
2.5 |
34 |
22 |
35 |
30 ± 7 |
|
1.25 |
31 |
27 |
24 |
27 ± 4 |
|
0.625 |
31 |
29 |
35 |
32 ± 3 |
|
0.3125 |
27 |
36 |
29 |
31 ± 5 |
a Average of colonies was shown as Mean ± S.D., the data were triplicate.
b Positive control group: With S9 Mix: Benzo [a] pyrene (4.0μg/plate).
Without S9 Mix: 4-Nitroquinoline-N-oxide (0.5μg/plate).
* Reverse mutant colony number were twice more than negative control group, ρ < 0.05 (One-Way ANOVA).
Table 4. Reverse mutation test of Salmonella typhimurium TA100
Group |
Test article (mg/plate) |
Reverse mutant colony number (CFU/plate) |
Average of coloniesa |
||
1 |
2 |
3 |
|||
With S9 Mix |
Negative control group |
210 |
193 |
200 |
201 ± 9 |
Positive control groupb |
1332 |
1415 |
1372 |
1373 ± 42* |
|
Test group |
|
|
|
|
|
5 |
176 |
171 |
178 |
175 ± 4 |
|
2.5 |
204 |
222 |
178 |
201 ± 22 |
|
1.25 |
206 |
199 |
189 |
198 ± 9 |
|
0.625 |
211 |
203 |
186 |
200 ± 13 |
|
0.3125 |
219 |
204 |
192 |
205 ± 14 |
|
Without S9 Mix |
Negative control group |
214 |
204 |
185 |
201 ± 15 |
Positive control group |
842 |
819 |
827 |
829 ± 12* |
|
Test group |
|
|
|
|
|
5 |
209 |
235 |
195 |
213 ± 20 |
|
2.5 |
205 |
195 |
209 |
203 ± 7 |
|
1.25 |
187 |
223 |
212 |
207 ± 18 |
|
0.625 |
209 |
204 |
219 |
211 ± 8 |
|
0.3125 |
216 |
177 |
233 |
209 ± 29 |
a Average of colonies was shown as Mean ± S.D., the data were triplicate.
b Positive control group: With S9 Mix: 2-Aminoanthracene (4.0μg/plate).
Without S9 Mix: Sodium azide (5μg/plate).
* Reverse mutant colony number were twice more than negative control group, ρ < 0.05 (One-Way ANOVA).
Table 5. Reverse mutation test of Salmonella typhimurium TA102
Group |
Test article (mg/plate) |
Reverse mutant colony number (CFU/plate) |
Average of coloniesa |
||
1 |
2 |
3 |
|||
With S9 Mix |
Negative control group |
486 |
435 |
461 |
461 ± 26 |
Positive control groupb |
1065 |
1136 |
1073 |
1091 ± 39* |
|
Test group |
|
|
|
|
|
5 |
387 |
409 |
393 |
396 ± 11 |
|
2.5 |
442 |
454 |
470 |
455 ± 14 |
|
1.25 |
407 |
383 |
428 |
406 ± 23 |
|
0.625 |
426 |
409 |
461 |
432 ± 27 |
|
0.3125 |
489 |
466 |
446 |
467 ± 22 |
|
Without S9 Mix |
Negative control group |
400 |
339 |
372 |
370 ± 31 |
Positive control group |
839 |
834 |
870 |
848 ± 20* |
|
Test group |
|
|
|
|
|
5 |
371 |
363 |
357 |
364 ± 7 |
|
2.5 |
353 |
375 |
336 |
355 ± 20 |
|
1.25 |
372 |
390 |
361 |
374 ± 15 |
|
0.625 |
418 |
357 |
404 |
393 ± 32 |
|
0.3125 |
390 |
315 |
375 |
360 ± 40 |
a Average of colonies was shown as Mean ± S.D., the data were triplicate.
b Positive control group: With S9 Mix: 2-Aminoanthracene (10μg/plate).
Without S9 Mix: Mitomycin C (0.5μg/plate).
* Reverse mutant colony number were twice more than negative control group, ρ < 0.05 (One-Way ANOVA).
Table 6. Reverse mutation test of Salmonella typhimurium TA1535
Group |
Test article (mg/plate) |
Reverse mutant colony number (CFU/plate) |
Average of coloniesa |
||
1 |
2 |
3 |
|||
With S9 Mix |
Negative control group |
20 |
15 |
24 |
20 ± 5 |
Positive control groupb |
278 |
301 |
285 |
288 ± 12* |
|
Test group |
|
|
|
|
|
5 |
23 |
17 |
16 |
19 ± 4 |
|
2.5 |
14 |
25 |
18 |
19 ± 6 |
|
1.25 |
27 |
20 |
22 |
23 ± 4 |
|
0.625 |
16 |
17 |
29 |
21 ± 7 |
|
0.3125 |
29 |
27 |
23 |
26 ± 3 |
|
Without S9 Mix |
Negative control group |
22 |
21 |
20 |
21 ± 1 |
Positive control group |
259 |
244 |
246 |
250 ± 8* |
|
Test group |
|
|
|
|
|
5 |
18 |
26 |
22 |
22 ± 4 |
|
2.5 |
20 |
24 |
25 |
23 ± 3 |
|
1.25 |
28 |
30 |
19 |
26 ± 6 |
|
0.625 |
25 |
18 |
31 |
25 ± 7 |
|
0.3125 |
30 |
27 |
25 |
27 ± 3 |
a Average of colonies was shown as Mean ± S.D., the data were triplicate.
b Positive control group: With S9 Mix: 2-Aminoanthracene (4.0μg/plate).
Without S9 Mix: Sodium azide (0.4μg/plate).
* Reverse mutant colony number were twice more than negative control group, ρ < 0.05 (One-Way ANOVA).
Table 7. Reverse mutation test of Salmonella typhimurium TA1537
Group |
Test article (mg/plate) |
Reverse mutant colony number (CFU/plate) |
Average of coloniesa |
||
1 |
2 |
3 |
|||
With S9 Mix |
Negative control group |
20 |
18 |
17 |
18 ± 2 |
Positive control groupb |
477 |
445 |
451 |
458 ± 17* |
|
Test group |
|
|
|
|
|
5 |
10 |
7 |
13 |
10 ± 3 |
|
2.5 |
12 |
17 |
11 |
13 ± 3 |
|
1.25 |
15 |
22 |
23 |
20 ± 4 |
|
0.625 |
16 |
15 |
10 |
14 ± 3 |
|
0.3125 |
11 |
13 |
19 |
14 ± 4 |
|
Without S9 Mix |
Negative control group |
18 |
16 |
16 |
17 ± 1 |
Positive control group |
606 |
768 |
713 |
696 ± 82* |
|
Test group |
|
|
|
|
|
5 |
13 |
10 |
20 |
14 ± 5 |
|
2.5 |
17 |
11 |
19 |
16 ± 4 |
|
1.25 |
10 |
9 |
11 |
10 ± 1 |
|
0.625 |
14 |
13 |
12 |
13 ± 1 |
|
0.3125 |
18 |
15 |
23 |
19 ± 4 |
a Average of colonies was shown as Mean ± S.D., the data were triplicate.
b Positive control group: With S9 Mix: 2-Aminoanthracene (4.0μg/plate).
Without S9 Mix: 9-Aminoacridine (50.0μg/plate).
*Reverse mutant colony number were twice more than negative control group, ρ < 0.05 (One-Way ANOVA).
Table 1. Cell viability test
Processing Time |
Groups |
Absorbance (570 nm)a |
Cell Viability (%)b |
Processed for 3 hours (with S9 Mix) |
Negative controlc |
0.997 ± 0.089 |
100.0 |
Positive controld |
0.906±0.094 |
90.8 ± 9.4 |
|
Test group (mg/mL) |
|
|
|
2.0 |
0.761 ± 0.111 |
76.3 ± 11.2 |
|
1.0 |
0.839 ± 0.066 |
84.1 ± 6.7 |
|
0.5 |
0.647 ± 0.055 |
64.9 ± 5.5 |
|
0.25 |
0.798 ± 0.078 |
80.0 ± 7.8 |
|
0.125 |
1.268 ± 0.108 |
127.2 ± 10.8 |
|
Processed for 3 hours (without S9 Mix) |
Negative control |
1.694 ± 0.202 |
100.0 |
Positive control |
1.354 ± 0.180 |
79.9 ± 10.6 |
|
Test group (mg/mL) |
|
|
|
2.0 |
1.278 ± 0.070 |
75.5 ± 4.2 |
|
1.0 |
1.494 ± 0.152 |
88.2 ± 8.9 |
|
0.5 |
1.284 ± 0.062 |
75.8 ± 3.7 |
|
0.25 |
1.233 ± 0.014 |
72.8 ± 0.8 |
|
0.125 |
1.247 ± 0.181 |
73.6 ± 10.7 |
|
Processed for 20 hours (without S9 Mix) |
Negative control |
1.686 ± 0.169 |
100.0 |
Positive control |
1.563 ± 0.035 |
92.7 ± 2.1 |
|
Test group (mg/mL) |
|
|
|
2.0 |
1.686 ± 0.037 |
100.0 ± 2.2 |
|
1.0 |
1.523 ± 0.110 |
90.3 ± 6.5 |
|
0.5 |
1.327 ± 0.114 |
78.7 ± 6.8 |
|
0.25 |
1.300 ± 0.068 |
77.1 ± 4.1 |
|
0.125 |
1.106 ± 0.066 |
65.6 ± 3.9 |
a Values were expressed as Mean ± S.D., and tests were triplicate.
b Cell viability = each absorbance of the positive control or test groups / the average of absorbance of the negative control × 100%, than calculated the Mean ± S.D..
c Negative control: Ham’s F-12 medium with 1% DMSO and 10% FBS (with or without S9 Mix).
d Positive control: Group included 25μg/mL cyclophosphamide monohydrate for the cells treated with S9 Mix, and 2.5μg/mL mitomycin C for the cells treated without S9 Mix.
Table 2. The cell proportion with abnormal chromosome
Group |
The cell proportion with abnormal chromosome(%) |
||
Processed for 3 hours (with S9 Mix) |
Processed for 3 hours (without S9 Mix) |
Processed for 20 hours (without S9 Mix) |
|
Negative control |
0.0 |
0.0 |
0.0 |
Positive control |
8.7 |
8.0 |
13.7 |
Test group (mg/mL) |
|
|
|
2.0 |
0.0 |
0.0 |
0.7 |
1.0 |
0.0 |
0.0 |
0.0 |
0.5 |
0.0 |
0.0 |
0.0 |
a Tests were repeated triplicate.
b Negative control: Ham’s F-12 medium with 1% DMSO and 10% FBS (with or without S9 Mix).
c Positive control: Group included 25μg/mL cyclophosphamide monohydrate for the cells treated with S9 Mix, and 2.5μg/mL mitomycin C for the cells treated without S9 Mix.
Table 1. Cell viability analysis
Group |
Test article |
Average colony numbersa |
Relative survival (%)b |
With S9 Mix |
Negative controlc |
176.6 ± 3.6 |
100.0 |
Positive controld |
165.4 ± 6.7 |
93.7 ± 3.8 |
|
Test groups (mg/mL) |
|
|
|
2.0 |
199.8 ± 11.4 |
113.1 ± 6.4 |
|
1.0 |
214.8 ± 7.9 |
121.6 ± 4.4 |
|
0.5 |
196.8 ± 4.4 |
111.4 ± 2.5 |
|
0.25 |
203.8 ± 6.1 |
115.4 ± 3.5 |
|
Without S9 Mix |
Negative controlc |
192.6 ± 5.5 |
100.0 |
Positive controld |
140.0 ± 9.8 |
72.7 ± 5.1 |
|
Test groups (mg/mL) |
|
|
|
2.0 |
187.6 ± 9.1 |
97.4 ± 4.7 |
|
1.0 |
202.2 ± 5.6 |
105.0 ± 2.9 |
|
0.5 |
183.6 ± 2.7 |
95.3 ± 1.4 |
|
0.25 |
185.6 ± 2.6 |
96.4 ± 1.4 |
a Values were expressed as Mean ± S.D., and tests were repeated 5 times.
b Relative survival = each colony numbers of the positive control or test groups / the average of colony numbers in the negative control × 100%, then calculated the Mean ± S.D..
c Negative control: Ham’s F-12 medium with 1% DMSO and 10% FBS (S9 Mix or not).
d Positive control: 4μg/mL B[a]P for the cell treated with S9 Mix, and 0.25μg/mL 4-NQO for the cells treated without S9 Mix.
Table 2. Mutation frequency analysis
Group |
Test article |
Average colony numbersa |
Mutation frequency (× 10-6)b |
With S9 Mix |
Negative controlc |
6.4 ± 1.3 |
17.6 |
Positive controld |
35.2 ± 4.8 |
110.7* |
|
Test groups (mg/mL) |
|
|
|
2.0 |
5.8 ± 2.4 |
18.0 |
|
1.0 |
4.0 ± 2.0 |
8.7 |
|
0.5 |
4.4 ± 1.9 |
7.0 |
|
0.25 |
2.8 ± 1.3 |
5.4 |
|
Without S9 Mix |
Negative controlc |
7.2 ± 0.8 |
13.2 |
Positive controld |
41.8 ± 6.1 |
92.3* |
|
Test groups (mg/mL) |
|
|
|
2.0 |
10.6 ± 1.5 |
18.0 |
|
1.0 |
11.4 ± 3.6 |
16.1 |
|
0.5 |
8.8 ± 1.3 |
13.6 |
|
0.25 |
4.2 ± 0.8 |
6.6 |
a Values were expressed as Mean ± S.D., and tests were repeated 5 times.
b Mutation frequency = (average colony numbers of each test groups / the number of seeding) × (1 / Colonies formation frequency).
c Negative control: Ham’s F-12 medium with 1% DMSO and 10% FBS (S9 Mix or not).
d Positive control: 4μg/mL B[a]P for the cell treated with S9 Mix, and 0.25μg/mL 4-NQO for the cells treated without S9 Mix.
* Significantly different from the negative control group (ρ < 0.005).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Bacterial reverse mutation test (OECD TG471)
Based on the preliminary assay results, 5mg/plate was set as the highest dose in this study. In the mutagenicity assay, five doses of Everzol SB26 at 0.3125, 0.625, 1.25, 2.5 and 5mg/plate, concurrent negative and strain-specific positive controls were tested in tester strains TA98, TA100, TA102, TA1535 and TA1537 in triplicate with or without S9 Mix activation. In the range-finding test for toxicity of the Everzol SB26, no toxicity was observed in all five tester strains up to 5 mg/plate in the absence and presence of metabolite activations. Results showed that Everzol SB26 did not increase the number of revertants in all five tester strains TA98, TA100, TA102, TA1535 and TA1537 up to 5mg/plate either in the absence or in the presence of metabolite activation.
Based on the data obtained from this study, it was concluded that under the test condition, Everzol SB26 was not mutagenic in the reverse mutation analysis of Salmonella typhimuriumup to 5mg/plate in the absence and presence of S9 metabolic activation.
Mammalian chromosomal aberration test (OECD TG473)
Based on the results of the cell viability test, 2.0 mg/mL was set as the highest dose in this study. In the chromosome aberration test, three doses of Everzol SB26 at 0.5, 1.0 and 2.0mg/mL, negative and positive controls were tested in triplicate with or without S9 Mix. The cell proportion with abnormal chromosome was lower than 3% for all test groups in the absence and presence of S9 Mix. Based on the data obtained from this study, it was concluded that under the test condition, Everzol SB26 was negative effect in vitro mammalian chromosome aberration test.
Mammalian cell gene mutation tests(OECD TG476)
Based on the results of the cell viability test, 2.0 mg/mL was set as the highest dose in this study. In the gene mutation test, four doses of Everzol SB26 at 0.25, 0.5, 1.0 and 2.0 mg/mL, negative and positive controls were tested in five repetitions with or without S9 Mix. The mutation frequency was no significantly different from the negative control group for all test groups in the absence and presence of S9 Mix. Based on the data obtained from this study, it was concluded that under the test condition, Everzol SB26 was negative effect in mammalian cell gene mutation test (in vitro).
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