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EC number: 480-890-9 | CAS number: 906532-68-1
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- -
- EC Number:
- 480-890-9
- EC Name:
- -
- Cas Number:
- 906532-68-1
- Molecular formula:
- C23H24N6O17S5 · xNa
- IUPAC Name:
- sodium 3,5-diamino-2-[(E)-2-{2-sulfo-4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]-4-[(E)-2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]benzoate
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- The post-mitochondrial fraction (S9) of liver from Aroclor 1254 induced Sprague-Dawley rats was purchased from MOLTOX, Molecular Toxicology Inc., USA and was used for metabolic activation.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 0, 50, 150, 500, 1500, 5000 µg/ml
Concentration range in the main test (without metabolic activation): 0, 50, 150, 500, 1500, 5000 µg/ml - Vehicle / solvent:
- Culture medium
Controls
- Untreated negative controls:
- yes
- Remarks:
- 10% sterile deionized water in culture medium was used as the negative control.
- Positive controls:
- yes
- Remarks:
- Mitomycin C at 1 µM ( µg/mL) was used as the positive control for 3-hour and 20-hour treatments without S9 activation. Cyclophosphamide at 40 uM was used for 3-hr treatment with S9 activation.
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 3 hours
Exposure period (without metabolic activation): 3 hours
Exposure period (without metabolic activation): 20 hours
Fixation time:
With/without S9: 3h exposure, 24h fixation (experiment 1)
Without S9: 24h exposure, 24h fixation time (experiment 2)
Without S9: 48h exposure, 48h fixation time (experiment 2)
With 3h exposure, 48h fixation (experiment 2)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 3hr, at the concentraion: 150 µg/ml, 500 µg/ml
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Concurrent Cytotoxicity Test:
Measurements of cytotoxicity for all treated and negative control cultures were conducted at the time of mitotic cell harvest. The cytotoxicity at all concentrations for all three schemes did not show more than 50% cqtotoxicity. The maximum top concentration recommended was used for all three schemes. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Concurrent Cytotoxicity analysis of Everzol Orange ED-G Crude in Chinese Hamster Ovary Cells
Concentration (μg/mL) | Cell number (X E5 cells) | Survival (%) | Cytotoxicity (%) |
Scheme I (-S9, 3h) | |||
Negative control | 30.7 | 100.0 | 0.0 |
50 | 26.4 | 86.0 | 14.0 |
150 | 30.1 | 98.0 | 2.0 |
500 | 24.7 | 80.5 | 19.5 |
1500 | 24.7 | 80.5 | 19.5 |
5000 | 23.2 | 75.6 | 24.4 |
Scheme II (+S9, 3h) | |||
Negative contral | 23.9 | 100.0 | 0.0 |
50 | 30.7 | 100.0 | 0.0 |
150 | 28.9 | 100.0 | 0.0 |
500 | 13.4 | 56.1 | 43.9 |
1500 | 13.2 | 55.2 | 44.8 |
5000 | 26.9 | 100.0 | 0.0 |
Scheme III (-S9, 20h) | |||
Negative control | 31.2 | 100.0 | 0.0 |
50 | 31.6 | 100.0 | 0.0 |
150 | 29.2 | 93.6 | 6.4 |
500 | 25.5 | 81.7 | 18.3 |
1500 | 22.6 | 72.4 | 27.6 |
5000 | 19.0 | 60.9 | 39.1 |
Summary of Chromosome aberrations in Chinese Hamster Ovary cells
Concentration (μg/mL) | Aberrant Cells (%) |
Scheme I (-S9, 3h) | |
Negative control, 0 | 1 |
50 | 0.5 |
150 | 1 |
500 | 1.5 |
1500 | 0.5 |
5000 | 0.5 |
Positive control (MMC) 0.33 | 25 |
Scheme II (+S9, 3h) | |
Negative control, 0 | 0 |
50 | 1.5 |
150 | 8 |
500 | 9.5 |
1500 | Too few metaphases |
5000 | Too few metaphases |
Positive control (CPP) | 22.5 |
Scheme III (-S9, 20h) | |
Negative control, 0 | 0.5 |
50 | 0 |
150 | 0.5 |
500 | 3 |
1500 | Too few metaphases |
5000 | Too few metaphases |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
negative without metabolic activation
In conclusion, Everzol Orange ED-G Crude did not induce structural chromosome aberration in CHO cells for all concentrations in the absence of S9 but induce structural chromosome aberration at the concentrations of 150 and 500 µg/ml in the presence of S9 for 3-hour treatment. - Executive summary:
The chromosome aberration assay was conducted in three test schemes: 3-hour exposure both with and without S9 activation (schemes I and II) and 20-hour continuous exposure without S9 (scheme III). Results were conducted in duplicate cultures and with negative control and positive controls concurrently. 100 metaphases for each culture and 200 metaphases for each treatment were scored. Results showed that percents of aberrant cells induced by negative control in the scheme I, II and III were 1%, 0% and 0.5%. The positive control induced significant increases in percents of aberrant cells over the corresponding negative control. Everzol Orange ED-G did not significantly increase the frequencies of structural chromosome aberration in the schemes I and III. However, the frequencies of structural chromosome aberration in the scheme II, at concentration of 150 and 500 um/mL in the 3 hr incubation have significantly increased.
In conclusion, Everzol Orange ED-G crude induced structural chromosome aberration at the concentration of 150 and 500 μg/mL at the presence of S9 for 3-hr treatment. The concentration-response analysis and trend probability were conducted in the 3-hr treatment with S9 and results showed lacking in concentration response.
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