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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 4, 2018 to March 14, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- 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 gene mutation test using the Hprt and xprt genes
Test material
- Reference substance name:
- Reaction products of cuprate(4-), [C-(aminosulfonyl)-C-[[[2-[[4-chloro-6-[(2,5-disulfophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]sulfonyl]-29H,31H-phthalocyanine-C,C-disulfonato(6-)-N29,N30,N31,N32]-, tetrasodium and lithium chloride
- Molecular formula:
- C43H24ClCuN15O16S6.xLi.yNa, (x + y) = 4; 0 < (x,y) < 4 with 1341.9 < MW < 1374 g/mol (UVCB substance), and traces of NaCl and NaSO4
- IUPAC Name:
- Reaction products of cuprate(4-), [C-(aminosulfonyl)-C-[[[2-[[4-chloro-6-[(2,5-disulfophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]sulfonyl]-29H,31H-phthalocyanine-C,C-disulfonato(6-)-N29,N30,N31,N32]-, tetrasodium and lithium chloride
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Remarks:
- CHO-K1
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- Based on the preliminary test result of cytotoxicity, the highest dose tested in this assay was 5000 ug/mL.
- Vehicle / solvent:
- Dimethylsulfoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Remarks:
- Ultrapure water
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
- Details on test system and experimental conditions:
- Based on the preliminary test result of cytotoxicity, the definite test were performed at 5000, 2000, 8000 and 320 µg/mL, and two replicates were prepared for each level. The groups were treated for 4 hours with metabolic activation, 4 hour without metabolic activation and 24 hours without metabolic activation.
- Evaluation criteria:
- 1. Test Validity
When the PE0 of negative control = 60%-140%, PE2 of negative control = 40%-140%; MF of the positive control ≥ 2-fold the negative control value, this study will be considered valid.
2. Result Evaluation
A test item is consider positive if it meets both of the following criteria:
(1) At least one or more concentration produces a concentration-related increase in mutant frequency.
(2) MF of the test item ≥ 2-fold the negative control value.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Remarks:
- CHO-K1
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- At the beginning and the end of treatment, no precipitate was observed in other dose.
Any other information on results incl. tables
Table 1. The Cytotoxicity Effect of CJ303 on L5178Y Cell
Treatment | Dose (µg/mL) | PE0 (%) | RS0 (%) | RSG (%) | RS2 (%) | RTG (%) |
S9- 24h |
Negative control | 63.3 | 100.0 | 100.0 | 100.0 | 100.0 |
Solvent control | 60.7 | 95.9 | 132.5 | 96.9 | 128.4 | |
5000 | 50.3 | 79.5 | 43.3 | 91.5 | 39.6 | |
2000 | 58.0 | 91.6 | 102.4 | 105.1 | 107.6 | |
800 | 63.3 | 100.0 | 111.9 | 95.1 | 106.5 | |
320 | 65.8 | 104.0 | 118.4 | 91.3 | 108.2 | |
MMS | 64.8 | 102.3 | 80.7 | 97.2 | 78.5 | |
S9- 4h |
Negative control | 68.9 | 100.0 | 100.0 | 100.0 | 100.0 |
Solvent control | 62.2 | 90.4 | 75.6 | 104.2 | 78.8 | |
5000 | 63.2 | 91.7 | 94.1 | 89.6 | 84.3 | |
2000 | 69.7 | 101.2 | 159.8 | 76.5 | 122.2 | |
800 | 61.7 | 89.6 | 163.2 | 73.0 | 119.1 | |
320 | 67.7 | 98.3 | 122.9 | 94.5 | 116.1 | |
MMS | 53.2 | 77.3 | 147.9 | 81.2 | 120.1 | |
S9+ 4h |
Negative control | 62.0 | 100.0 | 100.0 | 100.0 | 100.0 |
Solvent control | 61.5 | 99.2 | 126.7 | 99.4 | 126.0 | |
5000 | 50.9 | 82.1 | 82.2 | 99.4 | 81.8 | |
2000 | 58.0 | 93.6 | 88.8 | 112.2 | 99.6 | |
800 | 63.1 | 101.7 | 96.5 | 113.9 | 109.9 | |
320 | 67.9 | 109.5 | 85.7 | 112.2 | 96.2 | |
CP | 60.7 | 97.9 | 134.6 | 98.6 | 132.7 |
Table 2. The mutant frequencies of CJ303 on L5178Y Cell
Treatment | Dose (µg/mL) | PE2 (%) | MF (10^-6) | SC (%) |
S9- 24h |
Negative control | 62.7 | 83.4 | 58.3 |
Solvent control | 60.7 | 120.0 | - | |
5000 | 57.4 | 86.0 | - | |
2000 | 65.9 | 94.9 | - | |
800 | 59.6 | 92.5 | - | |
320 | 57.2 | 119.3 | - | |
MMS | 60.9 | 488.4 | 72.9 | |
S9- 4h |
Negative control | 67.8 | 77.2 | 67.5 |
Solvent control | 70.6 | 93.0 | - | |
5000 | 60.7 | 74.3 | - | |
2000 | 51.8 | 92.6 | - | |
800 | 49.5 | 97.1 | - | |
320 | 64.0 | 116.0 | - | |
MMS | 55.0 | 524.3 | 78.2 | |
S9+ 4h |
Negative control | 60.5 | 80.3 | 69.3 |
Solvent control | 60.2 | 82.0 | - | |
5000 | 60.2 | 77.3 | - | |
2000 | 67.9 | 85.5 | - | |
800 | 68.9 | 94.8 | - | |
320 | 67.9 | 72.7 | - | |
CP | 59.7 | 522.8 | 72.5 |
Table 3-1. The count result of PE0 and PE2 (S9- 24h)
Dose (µg/mL) | Cell number | PE0 | PE2 | ||
EW | TW | EW | TW | ||
Negative control | 011 | 33 | 96 | 36 | 96 |
012 | 32 | 96 | 33 | 96 | |
021 | 40 | 96 | 35 | 96 | |
022 | 35 | 96 | 37 | 96 | |
Solvent control | D1 | 33 | 96 | 33 | 96 |
D2 | 40 | 96 | 40 | 96 | |
5000 | 41 | 46 | 96 | 35 | 96 |
42 | 40 | 96 | 42 | 96 | |
2000 | 31 | 40 | 96 | 35 | 96 |
32 | 36 | 96 | 32 | 96 | |
800 | 21 | 32 | 96 | 38 | 96 |
22 | 38 | 96 | 36 | 96 | |
320 | 11 | 43 | 96 | 41 | 96 |
12 | 33 | 96 | 36 | 96 | |
MMS | M1 | 40 | 96 | 32 | 96 |
M2 | 29 | 96 | 41 | 96 |
Table 3-2. The count result of PE0 and PE2 (S9- 4h)
Dose (µg/mL) | Cell number | PE0 | PE2 | ||
EW | TW | EW | TW | ||
Negative control | 011 | 30 | 96 | 31 | 96 |
012 | 29 | 96 | 33 | 96 | |
021 | 34 | 96 | 35 | 96 | |
022 | 35 | 96 | 31 | 96 | |
Solvent control | D1 | 34 | 96 | 31 | 96 |
D2 | 37 | 96 | 31 | 96 | |
5000 | 41 | 37 | 96 | 40 | 96 |
42 | 33 | 96 | 33 | 96 | |
2000 | 31 | 30 | 96 | 45 | 96 |
32 | 33 | 96 | 39 | 96 | |
800 | 21 | 40 | 96 | 44 | 96 |
22 | 32 | 96 | 43 | 96 | |
320 | 11 | 33 | 96 | 33 | 96 |
12 | 32 | 96 | 36 | 96 | |
MMS | M1 | 39 | 96 | 36 | 96 |
M2 | 43 | 96 | 44 | 96 |
Table 3-3. The count result of PE0 and PE2 (S9+ 4h)
Dose (µg/mL) | Cell number | PE0 | PE2 | ||
EW | TW | EW | TW | ||
Negative control | 011 | 35 | 96 | 37 | 96 |
012 | 37 | 96 | 34 | 96 | |
021 | 31 | 96 | 36 | 96 | |
022 | 40 | 96 | 39 | 96 | |
Solvent control | D1 | 39 | 96 | 38 | 96 |
D2 | 33 | 96 | 35 | 96 | |
5000 | 41 | 43 | 96 | 42 | 96 |
42 | 42 | 96 | 32 | 96 | |
2000 | 31 | 40 | 96 | 35 | 96 |
32 | 36 | 96 | 30 | 96 | |
800 | 21 | 35 | 96 | 35 | 96 |
22 | 35 | 96 | 29 | 96 | |
320 | 11 | 35 | 96 | 35 | 96 |
12 | 30 | 96 | 30 | 96 | |
CP | C1 | 40 | 96 | 39 | 96 |
C2 | 33 | 96 | 35 | 96 |
Applicant's summary and conclusion
- Conclusions:
- It was concluded that when tested up to 5000 µg/mL with or without metabolic activation, CJ303 did not induce any Gene Mutation in the L5178Y cell. The result of CJ303 in vitro Mammalian Cell Gene Mutation test was negative.
- Executive summary:
The mutagenic potential of CJ303 was assessed in the Mouse Lymphoma Cells (L5178Y), which can detect induced gene mutation.
L5178Y cells were exposed to CJ303 at the doses of 320µg/mL, 800µg/mL, 2000µg/mL and 5000µg/mL with metabolic activation for 4 hours, without metabolic activation for 4 hours and without metabolic activation for 24 hours, respectively. Dimethylsulfoxide (DMSO) was used as solvent control substances. Ultrapure water was used as negative control substances. Methyl methanesulfonate (MMS) and Cyclophosphamide (CP) were used as positive control substances for experiments with and without metabolic activation, respectively. After the treatment period, cytotoxicity was evaluated by the relative survival (relative to the negative control). All the culture were treated by trifluorothymidine (TF) to detect gene mutations.
When tested up to 5000µg/mL with or without metabolic activation, CJ303 did not induce any Gene Mutation in the L5178Y cell. The result of CJ303 in vitro Mammalian Cell Gene Mutation test was negative.
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