Registration Dossier
Registration Dossier
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EC number: 204-200-0 | CAS number: 117-61-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: Authoritative data base
- Title:
- Study ID: 619780
- Author:
- NTP database
- Year:
- 2 012
- Bibliographic source:
- NTP (National Toxicological Program)by Agency for Toxic Substances and Disease Registry; Division of Toxicology/Toxicology Information Branch, 1600 Clifton Road NE, E-29, Atlanta, Georgia 30333
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Ames Test: Preincubation:
In the standard protocol (preincubation) for conducting the Ames assay, a test tube containing a suspension of one strain of Salmonella typhimurium (or E. coli) plus S9 mix or plain buffer without S9, is incubated for 20 minutes at 37º C with the test chemical. Control cultures, with all the same ingredients except the test chemical, are also incubated. In addition, positive control cultures are prepared; these contain the particular bacterial tester strain under investigation, the various culture ingredients, and a known potent mutagen*. After 20 minutes, agar is added to the cultures and the contents of the tubes are thoroughly mixed and poured onto the surface of Petri dishes containing standard bacterial culture medium. The plates are incubated, and bacterial colonies that do not require an excess of supplemental histidine appear and grow. These colonies are comprised of bacteria that have undergone reverse mutation to restore function of the histidine-manufacturing gene. The number of colonies is usually counted after 2 days. - GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Benzidine-2,2’-disulphonic acid
- IUPAC Name:
- Benzidine-2,2’-disulphonic acid
- Reference substance name:
- Benzidine-2,2'-disulphonic acid
- EC Number:
- 204-200-0
- EC Name:
- Benzidine-2,2'-disulphonic acid
- Cas Number:
- 117-61-3
- Molecular formula:
- C12H12N2O6S2
- IUPAC Name:
- 4,4'-diamino-[1,1'-biphenyl]-2,2'-disulfonic acid
- Details on test material:
- - Name of test material: Benzidine-2,2’-disulphonic acid
- Molecular formula: C12H12N2O6S2
- Molecular weight: 344.369
- Substance type: organic
- Physical state: solid
Constituent 1
Constituent 2
Method
- Target gene:
- Salmonella Strain: TA100
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% HLI,30% HLI ,10% RLI ,30% RLI
- Test concentrations with justification for top dose:
- 0 -10000 ug/Plate
Controlsopen allclose all
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- other: Dimethyl Sulfoxide
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: absence of S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- other: Dimethyl Sulfoxide
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene ( with S9)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Remarks:
- 10% HLI(induced male Syrian hamster liver S9)
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Strain: TA100
| Dose |
No Activation
(Negative) |
No Activation
(Negative) |
10% HLI
(Negative) |
30% HLI
(Negative) |
10% RLI
(Negative) |
30% RLI
(Negative) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Protocol | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | ||||||
| ug/Plate | Mean | ± SEM | Mean | ± SEM | Mean | ± SEM | Mean | ± SEM | Mean | ± SEM | Mean | ± SEM |
0 |
127 | 8.3 | 127 | 14.7 | 145 | 2.4 | 167 | 5 | 133 | 5.2 | 155 | 7.7 |
100 |
149 | 13.5 | 149 | 1.2 | 157 | 5.3 | 147 | 11.3 | 162 | 8.4 | 150 | 10.8 |
333 |
153 | 3.5 | 121 | 18.8 | 156 | 6.7 | 160 | 5.9 | 149 | 0.6 | 151 | 9.9 |
1000 |
125 | 1.2 | 137 | 15.9 | 151 | 3.5 | 156 | 4.3 | 136 | 4.7 | 150 | 4.1 |
3333 |
141 | 6.8 | 133 | 7.2 | 135 | 5 | 141 | 2 | 134 | 3.5 | 144 | 10.8 |
10000 |
154 | 2 | 139 | 7.5 | 132 | 5.5 | 153 | 8.3 | 131 | 9.9 | 149 | 6.7 |
| Positive Control | 876 | 24 | 1009 | 15.9 | 400 | 48.5 | 723 | 5.8 | 288 | 3.6 | 501 | 36.2 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Genetic toxicity in vitro for Benzidine-2,2’-disulphonic acid in Salmonella (Strain: TA100) was observed to be negative with metabolic activation (10% HLI ; 30% HLI; 10% RLI; 30% RLI) and without metabolic activation. - Executive summary:
Genetic toxicity in vitro for Benzidine-2,2’-disulphonic acid in Salmonella (Strain: TA100) was observed to be negative with metabolic activation (10% HLI ; 30% HLI; 10% RLI; 30% RLI) and without metabolic activation.
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