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EC number: 855-027-8 | CAS number: 2409921-75-9
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Genetic toxicity in vitro
Description of key information
CR SB33 was not mutagenic in the reverse mutation analysis of Salmonella typhimurium up to 5 mg/plate in the absence and presence of S9 metabolic activation (OECD TG471).
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 January 4, 2019 to September 16, 2019
- 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
- Test concentrations with justification for top dose:
- Range-finding test showed that article without rat S9 Mix and without hamster S9 Mix at the dose of 5 mg/plate did not cause toxicity to all tested strains. Therefore, the highest dose on definitive test was 5 mg/plate, other four doses were 2.5, 1.25, 0.625 and 0.3125 mg/plate, respectively.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Reverse osmosis water
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- Culture medium: Nutrient broth (NB No.2).
Incubation condition: 35±1℃ - Evaluation criteria:
- 1. Positive response criteria: The test chemical was considered to be positively reactive if any of the following criteria was fulfilled.
1.a The colony number of at least one of the dose groups was higher two folds than negative control group, and calculated by statistic software SPSS, p<0.05 (Duncan's multiple range test of One-Way ANOVA).
1.b The colony number of at least one of the dose groups was higher two folds than negative control group, and presented dose-reponse relaationship.
2. Negative response criterion: The test results for each test group of test article failed to comply with the positive response criteria were judged the negative response. - 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
- Conclusions:
- According to OECD 471 test method, CR SB33 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 MZ6-181200025 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 CR SB33 show that test validity criteria was met.
Based on the preliminary assay results, 5 mg/plate was set as the highest dose in this study. In the mutagenicity assay, five doses of CR SB33 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 or hamster S9 Mix activation. No cytotoxicity was observed in all five tester strains up to 5 mg/plate in the absence and presence of metabolite activations. Results showed that CR SB33 did not increase the number of revertants in all five tester strains TA98, TA100, TA102, TA1535 and TA1537 up to 5 mg/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, CR SB33 was not mutagenic in the reverse mutation analysis of Salmonella typhimurium up to 5 mg/plate in the absence and presence of S9 metabolic activation.
Reference
Table 1. Toxicity of the test article ofSalmonella typhimurium(without rat S9 Mix)
Group | Control article/Test articlea | Colony number (CFU/plate) | |||||||||||
TA98 | TA100 | TA102 | TA1535 | TA1537 | |||||||||
1 | 2 | 1 | 2 | 1 | 2 | 1 | 2 | 1 | 2 | ||||
Without rat S9 Mix | Negative control article | 32 | 29 | 157 | 167 | 411 | 408 | 35 | 33 | 15 |
14 |
||
Positive control article |
281 |
328 |
716 |
783 |
959 |
932 |
201 |
200 |
213 |
211 |
|||
Test group (mg/plate) |
|
|
|
|
|
|
|
|
|||||
5 |
27 |
31 |
163 |
166 |
425 |
409 |
31 |
26 |
18 |
6 |
|||
2.5 |
33 |
21 |
148 |
154 |
407 |
432 |
40 |
29 |
19 |
9 |
|||
1.25 |
29 |
28 |
144 |
155 |
405 |
442 |
40 |
29 |
9 |
14 |
|||
0.625 |
31 |
21 |
168 |
162 |
401 |
435 |
39 |
30 |
9 |
14 |
|||
0.3125 | 35 | 28 | 162 | 161 | 425 | 408 | 37 | 30 | 18 | 11 |
aNegative control article: Reverse osmosis water; Positive control article: 4 -Nitroquinoline-1-oxide (0.5 μg/plate), Sodium azide (0.4, 5.0
μg/plate), Mitomycin C (0.5 μg/plate) and 9 -Aminiacridine (50.0 μg/plate).
Table 2. Toxicity of the test article ofSalmonella typhimurium(without hamster S9 Mix)
Group | Control article/Test articlea | Colony number (CFU/plate) | |||||||||||
TA98 | TA100 | TA102 | TA1535 | TA1537 | |||||||||
1 | 2 | 1 | 2 | 1 | 2 | 1 | 2 | 1 | 2 | ||||
Without hamster S9 Mix | Negative control article | 32 | 31 | 183 | 172 | 298 | 320 | 26 | 20 | 11 |
9 |
||
Positive control article |
229 |
306 |
624 |
589 |
805 |
812 |
196 |
175 |
489 |
449 |
|||
Test group (mg/plate) |
|
|
|
|
|
|
|
|
|||||
5 |
22 |
27 |
142 |
176 |
326 |
296 |
23 |
13 |
9 |
14 |
|||
2.5 |
25 |
31 |
159 |
171 |
342 |
332 |
20 |
17 |
11 |
9 |
|||
1.25 |
30 |
32 |
183 |
187 |
299 |
306 |
20 |
17 |
5 |
15 |
|||
0.625 |
28 |
29 |
183 |
177 |
330 |
316 |
24 |
15 |
10 |
12 |
|||
0.3125 | 33 | 31 | 199 | 176 | 308 | 349 | 15 | 20 | 15 | 6 |
aNegative control article: Reverse osmosis water; Positive control article: 4 -Nitroquinoline-1-oxide (0.5 μg/plate), Sodium azide (0.4, 5.0
μg/plate), Mitomycin C (0.5 μg/plate) and 9 -Aminiacridine (50.0 μg/plate).
Table 3. Reverse mutation test ofSalmonella typhimuriumTA98 (with and without rat S9 Mix)
Group | Control article/Test articlea | Colony number (CFU/plate) | Average of coloniesb |
|||||
1 |
2 |
3 | ||||||
With rat S9 Mix |
Negative control group |
29 |
23 |
33 |
28 ± 5 |
|||
Positive control group |
244 |
265 |
238 |
249 ± 14* |
||||
Test group (mg/plate) |
|
|||||||
5 |
28 |
28 |
22 |
26 ± 3 |
||||
2.5 |
31 |
29 |
27 |
29 ± 2 |
||||
1.25 |
23 |
36 |
20 |
26 ± 9 |
||||
0.625 |
24 |
21 |
30 |
25 ± 5 |
||||
0.3125 |
25 |
25 |
24 |
25 ± 1 |
||||
Without rat S9 Mix |
Negative control group |
39 |
34 |
31 |
35 ± 4 |
|||
Positive control group |
298 |
314 |
302 |
305 ± 8* |
||||
Test group (mg/plate) |
|
|
||||||
5 |
20 |
25 |
39 |
28 ± 10 |
||||
2.5 |
32 |
34 |
40 |
35 ± 4 |
||||
1.25 |
25 |
36 |
28 |
30 ± 6 |
||||
0.625 |
27 |
37 |
26 |
30 ± 6 |
||||
0.3125 |
30 |
26 |
35 |
30 ± 5 |
aNegative control article: Reverse osmosis water; Positive control group: Benzo[a]pyrene (4.0 μg/plate) in S9 activation group and 4 -Nitroquinoline-1-oxide (0.5 μg/plate) in without S9 activation group.
bAverage of colonies was shown as Mean ± SD, the data were triplicate.
*Reverse mutant colony number were twice more than negative control group or p<0.05 (Duncan's multiple range test of One-Way ANOVA).
Table 4. Reverse mutation test ofSalmonella typhimuriumTA98 (with and without hamster S9 Mix)
Group | Control article/Test articlea | Colony number (CFU/plate) | Average of coloniesb |
|||||
1 |
2 |
3 | ||||||
With hamster S9 Mix |
Negative control group |
32 |
39 |
38 |
36 ± 4 |
|||
Positive control group |
316 |
305 |
318 |
313 ± 7* |
||||
Test group (mg/plate) |
|
|||||||
5 |
44 |
42 |
35 |
40 ± 5 |
||||
2.5 |
42 |
31 |
38 |
37 ± 6 |
||||
1.25 |
30 |
36 |
39 |
35 ± 5 |
||||
0.625 |
36 |
30 |
38 |
35 ± 4 |
||||
0.3125 |
32 |
42 |
34 |
36 ± 5 |
||||
Without hamster S9 Mix |
Negative control group |
30 |
25 |
23 |
26 ± 4 |
|||
Positive control group |
218 |
258 |
274 |
250 ± 29* |
||||
Test group (mg/plate) |
|
|
||||||
5 |
39 |
28 |
35 |
34 ± 6 |
||||
2.5 |
25 |
23 |
25 |
24 ± 1 |
||||
1.25 |
34 |
30 |
30 |
31 ± 2 |
||||
0.625 |
22 |
30 |
29 |
27 ± 4 |
||||
0.3125 |
28 |
26 |
22 |
25 ± 3 |
aNegative control article: Reverse osmosis water; Positive control group: Benzo[a]pyrene (4.0 μg/plate) in S9 activation group and 4 -Nitroquinoline-1-oxide (0.5 μg/plate) in without S9 activation group.
bAverage of colonies was shown as Mean ± SD, the data were triplicate.
*Reverse mutant colony number were twice more than negative control group or p<0.05 (Duncan's multiple range test of One-Way ANOVA).
Table 5. Reverse mutation test ofSalmonella typhimuriumTA100 (with and without rat S9 Mix)
Group | Control article/Test articlea | Colony number (CFU/plate) | Average of coloniesb |
|||||
1 |
2 |
3 | ||||||
With rat S9 Mix |
Negative control group |
202 |
209 |
210 |
207 ± 4 |
|||
Positive control group |
692 |
634 |
708 |
678 ± 39* |
||||
Test group (mg/plate) |
|
|||||||
5 |
200 |
194 |
211 |
202 ± 9 |
||||
2.5 |
203 |
202 |
202 |
202 ± 1 |
||||
1.25 |
205 |
193 |
213 |
204 ± 10 |
||||
0.625 |
213 |
194 |
205 |
204 ± 10 |
||||
0.3125 |
198 |
217 |
205 |
207 ± 10 |
||||
Without rat S9 Mix |
Negative control group |
167 |
180 |
178 |
175 ± 7 |
|||
Positive control group |
759 |
765 |
752 |
759 ± 7* |
||||
Test group (mg/plate) |
|
|
||||||
5 |
182 |
180 |
175 |
179 ± 4 |
||||
2.5 |
185 |
187 |
173 |
182 ± 8 |
||||
1.25 |
176 |
171 |
183 |
177 ± 6 |
||||
0.625 |
171 |
180 |
178 |
176 ± 5 |
||||
0.3125 |
172 |
192 |
186 |
183 ± 10 |
aNegative control article: Reverse osmosis water; Positive control group: 2-Aminoanthracene (4.0 μg/plate) in S9 activation group and Sodium azide (5.0 μg/plate) in without S9 activation group.
bAverage of colonies was shown as Mean ± SD, the data were triplicate.
*Reverse mutant colony number were twice more than negative control group or p<0.05 (Duncan's multiple range test of One-Way ANOVA).
Table 6. Reverse mutation test ofSalmonella typhimuriumTA100 (with and without hamster S9 Mix)
Group | Control article/Test articlea | Colony number (CFU/plate) | Average of coloniesb |
|||||
1 |
2 |
3 | ||||||
With hamster S9 Mix |
Negative control group |
208 |
189 |
181 |
193 ± 14 |
|||
Positive control group |
740 |
760 |
795 |
765 ± 28* |
||||
Test group (mg/plate) |
|
|||||||
5 |
197 |
185 |
182 |
188 ± 8 |
||||
2.5 |
184 |
184 |
171 |
180 ± 8 |
||||
1.25 |
179 |
185 |
169 |
178 ± 8 |
||||
0.625 |
187 |
182 |
187 |
185 ± 3 |
||||
0.3125 |
195 |
169 |
196 |
187 ± 15 |
||||
Without hamster S9 Mix |
Negative control group |
198 |
185 |
183 |
189 ± 8 |
|||
Positive control group |
601 |
642 |
622 |
622 ± 21* |
||||
Test group (mg/plate) |
|
|
||||||
5 |
198 |
172 |
186 |
185 ± 13 |
||||
2.5 |
183 |
183 |
194 |
187 ± 6 |
||||
1.25 |
177 |
198 |
185 |
187 ± 11 |
||||
0.625 |
180 |
176 |
177 |
178 ± 2 |
||||
0.3125 |
185 |
195 |
173 |
184 ± 11 |
aNegative control article: Reverse osmosis water; Positive control group: 2-Aminoanthracene (4.0 μg/plate) in S9 activation group and Sodium azide (5.0 μg/plate) in without S9 activation group.
bAverage of colonies was shown as Mean ± SD, the data were triplicate.
*Reverse mutant colony number were twice more than negative control group or p<0.05 (Duncan's multiple range test of One-Way ANOVA).
Table 7. Reverse mutation test ofSalmonella typhimuriumTA102 (with and without rat S9 Mix)
Group | Control article/Test articlea | Colony number (CFU/plate) | Average of coloniesb |
|||||
1 |
2 |
3 | ||||||
With rat S9 Mix |
Negative control group |
417 |
390 |
398 |
402 ± 14 |
|||
Positive control group |
989 |
998 |
995 |
994 ± 5* |
||||
Test group (mg/plate) |
|
|||||||
5 |
396 |
387 |
402 |
395 ± 8 |
||||
2.5 |
402 |
392 |
405 |
400 ± 7 |
||||
1.25 |
418 |
413 |
395 |
409 ± 12 |
||||
0.625 |
412 |
414 |
386 |
404 ± 16 |
||||
0.3125 |
414 |
415 |
409 |
413 ± 3 |
||||
Without rat S9 Mix |
Negative control group |
395 |
385 |
384 |
388 ± 6 |
|||
Positive control group |
994 |
982 |
1093 |
1023 ± 61* |
||||
Test group (mg/plate) |
|
|
||||||
5 |
351 |
348 |
396 |
365 ± 27 |
||||
2.5 |
414 |
380 |
389 |
394 ± 18 |
||||
1.25 |
386 |
373 |
398 |
386 ± 13 |
||||
0.625 |
375 |
392 |
413 |
393 ± 19 |
||||
0.3125 |
368 |
382 |
403 |
384 ± 18 |
aNegative control article: Reverse osmosis water; Positive control group: 2-Aminoanthracene (10.0 μg/plate) in S9 activation group and Mitomycin C (0.5 μg/plate) in without S9 activation group.
bAverage of colonies was shown as Mean ± SD, the data were triplicate.
*Reverse mutant colony number were twice more than negative control group or p<0.05 (Duncan's multiple range test of One-Way ANOVA).
Table 8. Reverse mutation test ofSalmonella typhimuriumTA102 (with and without hamster S9 Mix)
Group | Control article/Test articlea | Colony number (CFU/plate) | Average of coloniesb |
|||||
1 |
2 |
3 | ||||||
With hamster S9 Mix |
Negative control group |
427 |
431 |
420 |
426 ± 6 |
|||
Positive control group |
1085 |
1084 |
1094 |
1088 ± 6* |
||||
Test group (mg/plate) |
|
|||||||
5 |
405 |
445 |
434 |
428 ± 21 |
||||
2.5 |
457 |
425 |
428 |
437 ± 18 |
||||
1.25 |
435 |
429 |
459 |
441 ± 16 |
||||
0.625 |
426 |
422 |
473 |
440 ± 28 |
||||
0.3125 |
428 |
446 |
439 |
438 ± 9 |
||||
Without hamster S9 Mix |
Negative control group |
315 |
298 |
326 |
313 ± 14 |
|||
Positive control group |
949 |
920 |
1010 |
960 ± 46* |
||||
Test group (mg/plate) |
|
|
||||||
5 |
312 |
333 |
316 |
320 ± 11 |
||||
2.5 |
306 |
287 |
293 |
295 ± 10 |
||||
1.25 |
303 |
340 |
329 |
324 ± 19 |
||||
0.625 |
317 |
357 |
327 |
334 ± 21 |
||||
0.3125 |
293 |
303 |
294 |
297 ± 6 |
aNegative control article: Reverse osmosis water; Positive control group: 2-Aminoanthracene (10.0 μg/plate) in S9 activation group and Mitomycin C (0.5 μg/plate) in without S9 activation group.
bAverage of colonies was shown as Mean ± SD, the data were triplicate.
*Reverse mutant colony number were twice more than negative control group or p<0.05 (Duncan's multiple range test of One-Way ANOVA).
Table 9. Reverse mutation test ofSalmonella typhimuriumTA1535 (with and without rat S9 Mix)
Group | Control article/Test articlea | Colony number (CFU/plate) | Average of coloniesb |
|||||
1 |
2 |
3 | ||||||
With rat S9 Mix |
Negative control group |
16 |
24 |
21 |
20 ± 4 |
|||
Positive control group |
184 |
205 |
206 |
198 ± 12* |
||||
Test group (mg/plate) |
|
|||||||
5 |
17 |
31 |
22 |
23 ± 7 |
||||
2.5 |
28 |
25 |
25 |
26 ± 2 |
||||
1.25 |
22 |
22 |
38 |
27 ± 9 |
||||
0.625 |
15 |
23 |
22 |
20 ± 4 |
||||
0.3125 |
22 |
21 |
24 |
22 ± 2 |
||||
Without rat S9 Mix |
Negative control group |
22 |
32 |
24 |
26 ± 5 |
|||
Positive control group |
238 |
234 |
228 |
233 ± 5* |
||||
Test group (mg/plate) |
|
|
||||||
5 |
25 |
29 |
20 |
25 ± 5 |
||||
2.5 |
23 |
27 |
24 |
25 ± 2 |
||||
1.25 |
25 |
21 |
29 |
25 ± 4 |
||||
0.625 |
28 |
32 |
31 |
30 ± 2 |
||||
0.3125 |
31 |
25 |
24 |
27 ± 4 |
aNegative control article: Reverse osmosis water; Positive control group: 2-Aminoanthracene (4.0 μg/plate) in S9 activation group and Sodium azide (0.4 μg/plate) in without S9 activation group.
bAverage of colonies was shown as Mean ± SD, the data were triplicate.
*Reverse mutant colony number were twice more than negative control group or p<0.05 (Duncan's multiple range test of One-Way ANOVA).
Table 10. Reverse mutation test ofSalmonella typhimuriumTA1535 (with and without hamster S9 Mix)
Group | Control article/Test articlea | Colony number (CFU/plate) | Average of coloniesb |
|||||
1 |
2 |
3 | ||||||
With hamster S9 Mix |
Negative control group |
21 |
11 |
17 |
16 ± 5 |
|||
Positive control group |
247 |
273 |
253 |
258 ± 14* |
||||
Test group (mg/plate) |
|
|||||||
5 |
20 |
21 |
18 |
20 ± 2 |
||||
2.5 |
20 |
17 |
23 |
20 ± 3 |
||||
1.25 |
17 |
22 |
15 |
18 ± 4 |
||||
0.625 |
19 |
19 |
27 |
22 ± 5 |
||||
0.3125 |
24 |
17 |
20 |
20 ± 4 |
||||
Without hamster S9 Mix |
Negative control group |
18 |
20 |
22 |
20 ± 2 |
|||
Positive control group |
228 |
245 |
218 |
230 ± 14* |
||||
Test group (mg/plate) |
|
|
||||||
5 |
14 |
22 |
15 |
17 ± 4 |
||||
2.5 |
22 |
16 |
17 |
18 ± 3 |
||||
1.25 |
17 |
19 |
22 |
19 ± 3 |
||||
0.625 |
21 |
18 |
22 |
20 ± 2 |
||||
0.3125 |
19 |
20 |
18 |
19 ± 1 |
aNegative control article: Reverse osmosis water; Positive control group: 2-Aminoanthracene (4.0 μg/plate) in S9 activation group and Sodium azide (0.4 μg/plate) in without S9 activation group.
bAverage of colonies was shown as Mean ± SD, the data were triplicate.
*Reverse mutant colony number were twice more than negative control group or p<0.05 (Duncan's multiple range test of One-Way ANOVA).
Table 11. Reverse mutation test ofSalmonella typhimuriumTA1537 (with and without rat S9 Mix)
Group | Control article/Test articlea | Colony number (CFU/plate) | Average of coloniesb |
|||||
1 |
2 |
3 | ||||||
With rat S9 Mix |
Negative control group |
14 |
7 |
11 |
11 ± 4 |
|||
Positive control group |
261 |
241 |
281 |
261 ± 20* |
||||
Test group (mg/plate) |
|
|||||||
5 |
10 |
13 |
9 |
11 ± 2 |
||||
2.5 |
17 |
10 |
11 |
13 ± 4 |
||||
1.25 |
11 |
13 |
7 |
10 ± 3 |
||||
0.625 |
15 |
12 |
7 |
11 ± 4 |
||||
0.3125 |
12 |
11 |
8 |
10 ± 2 |
||||
Without rat S9 Mix |
Negative control group |
12 |
11 |
9 |
11 ± 2 |
|||
Positive control group |
216 |
289 |
274 |
260 ± 39* |
||||
Test group (mg/plate) |
|
|
||||||
5 |
9 |
12 |
18 |
13 ± 5 |
||||
2.5 |
8 |
9 |
12 |
10 ± 2 |
||||
1.25 |
7 |
6 |
15 |
9 ± 5 |
||||
0.625 |
7 |
19 |
8 |
11 ± 7 |
||||
0.3125 |
11 |
6 |
9 |
9 ± 3 |
aNegative control article: Reverse osmosis water; Positive control group: 2-Aminoanthracene (4.0 μg/plate) in S9 activation group and 9-Aminoacridine (50.0 μg/plate) in without S9 activation group.
bAverage of colonies was shown as Mean ± SD, the data were triplicate.
*Reverse mutant colony number were twice more than negative control group or p<0.05 (Duncan's multiple range test of One-Way ANOVA).
Table 12. Reverse mutation test ofSalmonella typhimuriumTA1537 (with and without hamster S9 Mix)
Group | Control article/Test articlea | Colony number (CFU/plate) | Average of coloniesb |
|||||
1 |
2 |
3 | ||||||
With hamster S9 Mix |
Negative control group |
14 |
15 |
10 |
13 ± 3 |
|||
Positive control group |
472 |
480 |
457 |
470 ± 12* |
||||
Test group (mg/plate) |
|
|||||||
5 |
16 |
12 |
15 |
14 ± 2 |
||||
2.5 |
13 |
10 |
11 |
11 ± 2 |
||||
1.25 |
17 |
20 |
13 |
17 ± 4 |
||||
0.625 |
15 |
17 |
19 |
17 ± 2 |
||||
0.3125 |
17 |
13 |
22 |
17 ± 5 |
||||
Without hamster S9 Mix |
Negative control group |
15 |
17 |
13 |
15 ± 2 |
|||
Positive control group |
308 |
329 |
355 |
331 ± 24* |
||||
Test group (mg/plate) |
|
|
||||||
5 |
12 |
20 |
10 |
14 ± 5 |
||||
2.5 |
16 |
22 |
17 |
18 ± 3 |
||||
1.25 |
17 |
15 |
21 |
18 ± 3 |
||||
0.625 |
17 |
16 |
13 |
15 ± 2 |
||||
0.3125 |
17 |
12 |
20 |
16 ± 4 |
aNegative control article: Reverse osmosis water; Positive control group: 2-Aminoanthracene (4.0 μg/plate) in S9 activation group and 9-Aminoacridine (50.0 μg/plate) in without S9 activation group.
bAverage of colonies was shown as Mean ± SD, the data were triplicate.
*Reverse mutant colony number were twice more than negative control group or p<0.05 (Duncan's multiple range test of One-Way ANOVA).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Based on the preliminary assay results, 5 mg/plate was set as the highest dose in this study. In the mutagenicity assay, five doses of CR SB33 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. No cytotoxicity was observed in all five tester strains up to 5 mg/plate in the absence and presence of metabolite activations. Results showed that CR SB33 did not increase the number of revertants in all five tester strains TA98, TA100, TA102, TA1535 and TA1537 up to 5 mg/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, CR SB33 was not mutagenic in the reverse mutation analysis of Salmonella typhimurium up to 5mg/plate in the absence and presence of S9 metabolic activation.
Justification for classification or non-classification
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