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EC number: 216-407-3 | CAS number: 1576-35-8
- Life Cycle description
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed in accordance with the OECD guideline 473, and in compliance with GLP standard.
Cross-reference
- Reason / purpose:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- not specified
- Qualifier:
- according to
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): 4,4'-Oxybis(benzenesulfonyl hydrazide)
- Analytical purity: no data
- Purity test date: 99.3 wt%
- Lot/batch No.: 403650
Method
- Target gene:
- NA
Species / strain
- Species / strain / cell type:
- other: Chinese Hamster Lung (CHL/IU) Cells
- Details on mammalian cell type (if applicable):
- NA
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat, malem, liver, 30% S9 mix induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- Absence metabolic system; 0, 557, 696, 870, 1,088, 1,360, and 1,700 µg/mL
Presence metabolic system; 0, 357, 446, 557, 696, 870, and 1,088 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: no data
Controls
- Untreated negative controls:
- yes
- Remarks:
- solvent
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- Culture establishment: CHL cells in logarithmic were to maintain low aberration frequencies. Subcultured at low density, before over growth occurs. The cells were incubated at 37 C in atmosphere of 5 % (v/v) CO2 and 100 % humidity.
Description of follow up repeat study: Series of seven and ten concentration levels with 1.25-fold intervals were tested in the absence and the presence of metabolic activation system. - Evaluation criteria:
- The test was considered as positive in this assay if; 1) Statistically significant increase in the proportion of cells with structural aberrations (excluding gaps) occurs at one or more concentration levels 2) 1) exceed the normal range, 3) If the result of 1) is reproducible.
- Statistics:
- Fisher’s exact test and Chochran Armitage’s trend test (p-value: 0.05)
Results and discussion
Test results
- Species / strain:
- other: Chinese Hamster Lung (CHL/IU) Cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- -S9: at 1360 µg/mL and above. +S9: at 696µg/mL and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- None
Any other information on results incl. tables
Table 1. Chromosome aberration test on CHL cells treated with 4,4’-oxybis(benzenesulfonylhydrazide) [short-term treatment: -S9 mix]
Compound | Concentration (mg/mL) | Time of exposure (hr) | Relative cell growth (%) | No. of cells analyzed | No. of cells with aberrations –gap (%) | No. of cells analyzed for polyploid | No. of polyploid cells (%) | Final Judgment |
DMSOa) | 0 | 6 | 100.0 | 200 | 0 (0.0)# | 200 | 1 (0.5) |
|
Test substance | 557 | 6 | 47.7 | 200 | 8 (4.0)* | 200 | 1 (0.5) |
|
696 | 6 | 37.7 | 200 | 21 (10.5)* | 200 | 4 (2.0) |
| |
870 | 6 | 33.1 | 200 | 27 (13.5)* | 200 | 0 (0.0) | Positive | |
1088 | 6 | 18.0 | 200 | 6 (3.0)* | 200 | 2 (1.0) |
| |
1360c) | 6 | 9.1 | Toxic |
|
|
|
| |
1700c) | 6 | 3.0 | Toxic |
|
|
|
| |
MMCb) | 0.1 | 6 | 57.2 | 200 | 88 (44.0)* | 200 | 0 (0.0) | Positive |
-gap: total number of cells with aberrations except gap
# p≤0.05: Significant difference by trend test (Cochran-Armitage trend test)
* p≤0.05: Significant difference from the negative control group (Fisher’s exact test)
a) Negative control (Dimethyl sulfoxide), b) Positive control (Mitomycin C)
c) Visible precipitation was shown at the end of exposure period
Table 2. Chromosome aberration test on CHL cells treated with 4,4’-oxybis(benzenesulfonylhydrazide) [short-term treatment: +S9 mix]
Compound | Concentration (mg/mL) | Time of exposure (hr) | Relative cell growth (%) | No. of cells analyzed | No. of cells with aberrations –gap (%) | No. of cells analyzed for polyploid | No. of polyploid cells (%) | Final Judgment |
DMSOa) | 0 | 6 | 100.0 | 200 | 0 (0.0)# | 200 | 2(1.0) |
|
Test substance | 357 | 6 | 58.7 | 200 | 3 (1.5)* | 200 | 3(1.5) |
|
446 | 6 | 46.9 | 200 | 6 (3.0)* | 200 | 2(1.0) |
| |
557 | 6 | 18.2 | 200 | 29 (14.5)* | 200 | 0(0.0) | Positive | |
696 | 6 | 4.8 | Toxic |
|
|
|
| |
870 | 6 | 3.3 | Toxic |
|
|
|
| |
1088 | 6 | 2.4 | Toxic |
|
|
|
| |
CPb) | 12.5 | 6 | 85.4 | 200 | 66 (33.0)* | 200 | 1(0.5) | Positive |
-gap: total number of cells with aberrations except gap
# p≤0.05: Significant difference by trend test (Cochran-Armitage trend test)
* p≤0.05: Significant difference from the negative control group (Fisher’s exact test)
a) Negative control (Dimethyl sulfoxide), b) Positive control (Cyclophosphamide)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
The genetic toxicity of OBSH was evaluated in an in vitro Mammalian chromosome aberration test on chinese hamster ling cells. The study was performed in accordance with the OECD guideline 473. OBSH exhibited clastogenic activity on cultured Chinese Hamster Lung cells. - Executive summary:
The genetic toxicity of OBSH was evaluated in an in vitro Mammalian chromosome aberration test on chinese hamster lung cells. The study was performed in accordance with the OECD guideline 473.
Significant dose-dependent increases in the proportion of cells with structural aberrations were observed in cultures both in the absence (557 to 870mg/mL) and presence (446 to 557mg/mL) metabolic activation system. Significant increases in the proportion of cells with numerical aberrations were not observed in cultures at all concentration levels.
In conclusion, OBSH exhibited clastogenic activity on cultured Chinese Hamster Lung cells both with and without S9.
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