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EC number: 204-200-0 | CAS number: 117-61-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
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.
Link to relevant study records
- 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)
- 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
- Target gene:
- Salmonella Strain: TA100
- 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
- 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)
- 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'.
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vitro:
The available studies in the National Toxiclogical Program (NTP) database indicate that the chemical benzidine-2,2’-disulphonic acid is unlikely to exhibit genetic toxicity effect in the different strains of Salmonella (with or without metabolic activation).
The summary of the various studies is presented below
S. No |
Genetic Toxicity result |
Data source |
Species |
1 |
Negative |
NTP database |
S. typhimurium TA 100 |
2 |
Negative |
NTP database |
S. typhimurium TA 1535 |
3 |
Negative |
NTP database |
S. typhimurium TA 1538 |
4 |
Negative |
NTP database |
S. typhimurium TA 97 |
5 |
Negative |
NTP database |
S. typhimurium TA 98 |
Justification for selection of genetic toxicity endpoint
Data if from National Toxiclogical Program (NTP) database and hence considered to be reliable
Justification for classification or non-classification
From the available data, benzidine-2,2’-disulphonic acid is not classified as a genetic toxicant in the AMES study conducted with various Species of the Salmonella bacteria.
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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