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EC number: 942-667-9 | CAS number: -
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
CJ312 was not mutagenic in the reverse mutation analysis of Salmonella typhimuriumup to 5000 μg/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 February 18, 2016 to October 14, 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
- Target gene:
- Bacterial gene reverse mutation
- 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:
- The post-mitochondrial fraction (S9) prepared from Aroclor 1254-induced Sprague-Dawley rats
- Untreated negative controls:
- yes
- Remarks:
- Sterile deionized water
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: Acridine mutagen ICR 191, 2-Aminofluorene, 2-Aminoanthracene
- Evaluation criteria:
- Acceptable ranges of background revertants for five tester strains are:
Tester Strain Revertants
TA98 10-60
TA100 50-240
TA102 180-480
TA1535 5-45
TA1537 2-25 - Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- 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:
- no cytotoxicity
- 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:
- no cytotoxicity
- 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:
- no cytotoxicity
- 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:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- According to OECD 471 test method, CJ312 was not mutagenic in the reverse mutation analysis of Salmonella typhimurium up to 5000 μg/plate.
- Executive summary:
This test using the procedures outlined in the QPS Taiwan Study Plan for T65315030-GT which is based on the SOP for the OECD 471 (CTPS-TE00201) and OECD 471 (OECD,1997). The results of this OECD 471 test for CJ312 show that test validity criteria was met.
Based on the preliminary assay results, 5000μg/platewas set as the highest dose in this study. In the mutagenicity assay, five doses of CJ312 at 50, 150, 500, 1500 and 5000μg/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 5000μg/plate in the absence and presence of metabolite activations. Results showed that CJ312 did not increase the number of revertants in all five tester strains TA98, TA100, TA102, TA1535 and TA1537 up to 5000μg/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, CJ312 was not mutagenic in the reverse mutation analysis of Salmonella typhimurium up to 5000μg/plate in the absence and presence of S9 metabolic activation.
Reference
Table 1. Genotype Confirmation Tests of Salmonella typhimurium Tester Strains
Genotype character |
Phenotypic observation |
Tester Strains |
||||
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
||
Histidine requirement |
Growing on biotin plate |
- |
- |
- |
- |
- |
Growing on histidine/biotin plate |
+ |
+ |
+ |
+ |
+ |
|
rfa mutation |
Inhibition zone of crystal violet |
+ |
+ |
+ |
+ |
+ |
△uvrB mutation |
Growing on non UV-irradiated plate |
+ |
+ |
+ |
+ |
+ |
Growing on UV-irradiated plate |
- |
- |
+ |
- |
- |
|
R-factor |
Ampicillin resistance |
+ |
+ |
+ |
- |
- |
Genotype confirmed |
Passed |
Passed |
Passed |
Passed |
Passed |
+: the presence
-: the absence
Table 2. Mutagenicity Test of CJ312 in Salmonella typhimurium Strains without S9 Metabolic Activation
Treatment (μg/plate) |
Number of Revertant Colonies in Salmonella typhimurium |
|||||||||||||||
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
||||||||||||
replicate |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
|
Negative controla |
Ie |
19 |
23 |
25 |
81 |
84 |
55 |
335 |
394 |
407 |
6 |
13 |
20 |
14 |
14 |
16 |
Mf |
22 ± 3 |
73 ± 16 |
379 ± 38 |
13 ± 7 |
15 ± 1 |
|||||||||||
50 |
Ie |
22 |
28 |
25 |
89 |
84 |
63 |
360 |
352 |
366 |
24 |
24 |
13 |
24 |
17 |
18 |
Mf |
25 ± 3 |
79 ± 14 |
359 ± 7 |
20 ± 6 |
20 ± 4 |
|||||||||||
150 |
Ie |
18 |
17 |
14 |
82 |
59 |
66 |
382 |
407 |
423 |
12 |
10 |
13 |
17 |
16 |
6 |
Mf |
16 ± 2 |
69 ± 12 |
404 ± 21 |
12 ± 2 |
13 ± 6 |
|||||||||||
500 |
Ie |
25 |
27 |
30 |
73 |
72 |
83 |
372 |
358 |
379 |
12 |
13 |
21 |
11 |
14 |
12 |
Mf |
27 ± 3 |
76 ± 6 |
370 ± 11 |
15 ± 5 |
12 ± 2 |
|||||||||||
1500 |
Ie |
30 |
28 |
13 |
89 |
72 |
65 |
360 |
387 |
380 |
16 |
19 |
22 |
14 |
8 |
18 |
Mf |
24 ± 9 |
75 ± 12 |
376 ± 14 |
19 ± 3 |
13 ± 5 |
|||||||||||
5000 |
Ie |
21 |
24 |
25 |
87 |
79 |
72 |
329 |
351 |
360 |
21 |
17 |
11 |
16 |
16 |
20 |
Mf |
23 ± 2 |
79±8 |
347 ± 16 |
16 ± 5 |
17 ± 2 |
|||||||||||
Positive controlb |
Ie |
229 |
249 |
258 |
579 |
566 |
533 |
1450 |
1254 |
1272 |
419 |
366 |
321 |
167 |
199 |
223 |
Mf |
245c± 15 |
559c± 24 |
1325c± 108 |
369d± 49 |
196d± 28 |
a: Negative control was sterile deionized water.
b: Positive controls: 1μg/plate 2-nitrofluorene for TA98 0.5 μg/plate sodium azide for TA100
62.5μg/plate mitomycin C for TA102 0.1 μg/plate sodium azide for TA1535
0.5μg/plate acridine mutagen ICR 191 for TA1537
c: Greater than 2-fold negative control spontaneous revertants
d: Greater than 3-fold negative control spontaneous revertants
e: I: Number of revertants/plate is shown for each individual plate
f: M: The value of mean ± S.D. from triplicate plates of each treatment was calculated
Table 3. Mutagenicity Test of CJ312 in Salmonella typhimurium Strains with S9 Metabolic Activation
Treatment (μg/plate) |
Number of Revertant Colonies in Salmonella typhimurium |
|||||||||||||||
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
||||||||||||
replicate |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
|
Negative controla |
Ie |
34 |
32 |
34 |
88 |
122 |
78 |
338 |
336 |
376 |
7 |
13 |
12 |
14 |
19 |
10 |
Mf |
33 ± 1 |
96 ± 23 |
350 ± 23 |
11 ± 3 |
14 ± 5 |
|||||||||||
50 |
Ie |
47 |
15 |
34 |
90 |
93 |
98 |
338 |
369 |
367 |
7 |
7 |
15 |
11 |
14 |
15 |
Mf |
32 ± 16 |
94 ± 4 |
358 ± 17 |
10 ± 5 |
13 ± 2 |
|||||||||||
150 |
Ie |
29 |
26 |
29 |
95 |
76 |
101 |
366 |
338 |
382 |
10 |
17 |
11 |
19 |
14 |
13 |
Mf |
28 ± 2 |
91 ± 13 |
362 ± 22 |
13 ± 4 |
15 ± 3 |
|||||||||||
500 |
Ie |
29 |
20 |
35 |
91 |
78 |
82 |
310 |
322 |
359 |
7 |
12 |
15 |
6 |
20 |
9 |
Mf |
28 ± 8 |
84 ± 7 |
330 ± 26 |
11 ± 4 |
12 ± 7 |
|||||||||||
1500 |
Ie |
29 |
19 |
31 |
67 |
90 |
94 |
357 |
339 |
352 |
17 |
3 |
11 |
12 |
10 |
14 |
Mf |
26 ± 6 |
84 ± 15 |
349 ± 9 |
10 ± 7 |
12 ± 2 |
|||||||||||
5000 |
Ie |
27 |
16 |
26 |
105 |
97 |
84 |
401 |
396 |
335 |
9 |
16 |
10 |
9 |
12 |
13 |
Mf |
23 ± 6 |
95 ± 11 |
377 ± 37 |
12 ± 4 |
11 ± 2 |
|||||||||||
Positive controlb |
Ie |
177 |
193 |
191 |
663 |
708 |
641 |
1822 |
1914 |
1274 |
273 |
261 |
252 |
286 |
275 |
306 |
Mf |
187c± 9 |
671c± 34 |
1670c± 346 |
262d± 11 |
289d± 16 |
a: Negative control was sterile deionized water.
b: Positive controls: 0.5μg/plate 2-aminofluorene for TA98 4 μg/plate 2-aminofluorene for TA100
4μg/plate 2-aminoanthracene for TA102 1 μg/plate 2-aminoanthracene for TA1535
2μg/plate 2-aminoanthracene for TA1537
c: Greater than 2-fold negative control spontaneous revertants
d: Greater than 3-fold negative control spontaneous revertants
e: I: Number of revertants/plate is shown for each individual plate
f: M: The value of mean ± S.D. from triplicate plates of each treatment was calculated
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Genetic toxicity in vitro
Based on the preliminary assay results, 5000μg/plate was set as the highest dose in this study. In the mutagenicity assay, five doses of CJ312 at 50, 150, 500, 1500 and 5000μg/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 5000μg/plate in the absence and presence of metabolite activations. Results showed that CJ312 did not increase the number of revertants in all five tester strains TA98, TA100, TA102, TA1535 and TA1537 up to 5000μg/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, CJ312 was not mutagenic in the reverse mutation analysis ofSalmonellatyphimuriumup to 5000μg/plate in the absence and presence of S9 metabolic activation.
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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