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EC number: 202-947-7 | CAS number: 101-50-8
- 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
Description of key information
The No Observed Adverse Effect Level (NOAEL) for the test compound 4-aminoazobenzene-3,4'-disulphonic acid is found to be 792.237976074 mg/Kg bw (actual dose ingested) using rats.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
- Principles of method if other than guideline:
- Prediction is done using QSAR Toolbox version 3.3
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- No data
- Frequency of treatment:
- No data
- Remarks:
- Doses / Concentrations:No dataBasis:
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- No data
- Dose descriptor:
- NOAEL
- Effect level:
- 792.238 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- clinical signs
- Critical effects observed:
- not specified
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for the test compound 4-aminoazobenzene-3,4'-disulphonic acid is found to be 792.237976074 mg/Kg bw (actual dose ingested) using rats.
- Executive summary:
Repeated dose oral toxicity study was performed for the test compound 4-aminoazobenzene-3,4'-disulphonic acid using rats by the gavage route of exposure. The No Observed Adverse Effect Level (NOAEL) for the test compound 4-aminoazobenzene-3,4'-disulphonic acid is found to be 792.237976074 mg/Kg bw (actual dose ingested) using rats.
Reference
The prediction was based on dataset comprised from the following descriptors: NOAEL
Estimation method: Takes average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
(((("a" or "b" or "c" or "d" or "e" or "f" ) and ("g" and ( not "h") ) ) and ("i" and ( not "j") ) ) and ("k" and "l" ) )
Domain logical expression index: "a"
Referential boundary: The target chemical should be classified as Anilines (Acute toxicity) by US-EPA New Chemical Categories
Domain logical expression index: "b"
Referential boundary: The target chemical should be classified as Aniline AND Aryl AND Azo AND Sulfonic acid by Organic Functional groups
Domain logical expression index: "c"
Referential boundary: The target chemical should be classified as Aniline AND Aryl AND Azo AND Overlapping groups AND Sulfonic acid by Organic Functional groups (nested)
Domain logical expression index: "d"
Referential boundary: The target chemical should be classified as Aliphatic Nitrogen, one aromatic attach [-N] AND Aromatic Carbon [C] AND Azo [-N=N-] AND Hydroxy, sulfur attach [-OH] AND Miscellaneous sulfide (=S) or oxide (=O) AND Olefinic carbon [=CH- or =C<] AND Suflur {v+4} or {v+6} AND Sulfinic acid [-S(=O)OH] AND Sulfonate, aromatic attach [-SO2-O] by Organic functional groups (US EPA)
Domain logical expression index: "e"
Referential boundary: The target chemical should be classified as Amine AND Aromatic compound AND Azo compound AND Primary amine AND Primary aromatic amine AND Sulfonic acid AND Sulfonic acid derivative by Organic functional groups, Norbert Haider (checkmol)
Domain logical expression index: "f"
Referential boundary: The target chemical should be classified as Aromatic amines AND Sulfonic acids or their salts by Skin irritation/corrosion Inclusion rules by BfR
Domain logical expression index: "g"
Referential boundary: The target chemical should be classified as No alert found by DNA binding by OASIS v.1.3
Domain logical expression index: "h"
Referential boundary: The target chemical should be classified as Non-covalent interaction OR Non-covalent interaction >> DNA intercalation OR Non-covalent interaction >> DNA intercalation >> DNA Intercalators with Carboxamide Side Chain OR Non-covalent interaction >> DNA intercalation >> Fused-Ring Primary Aromatic Amines OR Radical OR Radical >> Radical mechanism via ROS formation (indirect) OR Radical >> Radical mechanism via ROS formation (indirect) >> Diazenes OR Radical >> Radical mechanism via ROS formation (indirect) >> Fused-Ring Primary Aromatic Amines OR Radical >> Radical mechanism via ROS formation (indirect) >> Nitroaniline Derivatives OR Radical >> Radical mechanism via ROS formation (indirect) >> Single-Ring Substituted Primary Aromatic Amines OR SN1 OR SN1 >> Nucleophilic attack after metabolic nitrenium ion formation OR SN1 >> Nucleophilic attack after metabolic nitrenium ion formation >> Fused-Ring Primary Aromatic Amines OR SN1 >> Nucleophilic attack after metabolic nitrenium ion formation >> Single-Ring Substituted Primary Aromatic Amines OR SN1 >> Nucleophilic attack after reduction and nitrenium ion formation OR SN1 >> Nucleophilic attack after reduction and nitrenium ion formation >> Nitroaniline Derivatives by DNA binding by OASIS v.1.3
Domain logical expression index: "i"
Referential boundary: The target chemical should be classified as No alert found by Protein binding alerts for Chromosomal aberration by OASIS v1.1
Domain logical expression index: "j"
Referential boundary: The target chemical should be classified as AN2 OR AN2 >> Michael addition to the quinoid type structures OR AN2 >> Michael addition to the quinoid type structures >> Substituted Anilines by Protein binding alerts for Chromosomal aberration by OASIS v1.1
Domain logical expression index: "k"
Parametric boundary:The target chemical should have a value of log Kow which is >= -2.08
Domain logical expression index: "l"
Parametric boundary:The target chemical should have a value of log Kow which is <= 0.773
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 792.238 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Prediction model based estimation
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: Oral
Repeated dose oral toxicity study was performed for the test compound 4-aminoazobenzene-3,4'-disulphonic acid using rats by the gavage route of exposure. The No Observed Adverse Effect Level (NOAEL) for the test compound 4-aminoazobenzene-3,4'-disulphonic acid is found to be 792.237976074 mg/Kg bw (actual dose ingested) using rats.
Sub chronic repeated dose toxicity test was carried by Sondergaard et al (1977) for the test compound disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzene sulphonate (RA CAS no 2706-28-7) with 2 male and 2 female SPF pigs of Danish Landrace. All pigs are dosed with 1000mg/kg and 1500mg/kg by gavage for total 77 days. Hematological examinations were performed at intervals and organ histopathology was performed at necropsy. No effects were detected and no Heinz bodies were found in the red blood cells. There is no significant toxic effect on the clinical & hematological parameters and on the examined liver and blood parameters. Therefore the NOAEL value is reported to be 1500mg/kg/day.
13 week subchronic toxicity study was conducted by Himri et al (2011) to evaluate the repeated dose toxic nature of the test compound tartrazine (RA CAS no 1934-21-0) on Wistar rats of both sexes. The animals were divided into 5 groups of 6 animals each, 3 of each sex, and fed a diet containing 5, 7.5, or 10 mg/kg b.w of Tartrazine. There were no treatment‐related adverse effects with regard to body weight, food and water consumption. Their blood samples were analyzed for hematological measurements, Glucose, Creatinine, Blood urea nitrogen, Cholesterol total, Triglecerid, alanine amino-transferase, aspartate amino-transferase. Tartrazine induced a morphological change from the discoid shape to an echinocytic form in rat RBCs. Relative weights of the liver were significantly increased in group treated with 10 mg/kg b.w, of Tartrazine. An increase in GLU, CREA, CHOL, TG, AST, and total Protein in serum of rats treated with Tartrazine and Sulfanilic acid compared to control rats was observed and these significant changes were more apparent in high doses than low ones. The histopathological changes of Liver and Kidney were in accordance with the biochemical findings. The Low Observed adverse effect level (LOAEL) for the test compound tartrazine is found to 7.5 mg/Kg bw.
The present study by Shinnawy et al (2013) was conducted to evaluate the possible influence of an azo dye (tartrazine, RA CAS no 1934-21-0) on some hematological and biochemical parameters of male albino rat Rattus norvegicus. Sixty adult male rats weighing 100-110g were divided into 3 groups; the first one served as a control, the second received 10mg/kg b.w. of tartrazine and the third group was treated with 25mg/kg b.w. of tartrazine. Rats were treated orally for 30 days followed a recovery for another 30 days. The data obtained reveal a marked decrease in the percentage of body weight gain, red blood cells (R.B.Cs) counts, hemoglobin (Hb) content, mean corpuscular hemoglobin concentration (MCHC), serum total lipids and serum total cholesterol of rats treated with the high dose of tartrazine. On the other hand, a noticeable increase in hematocrit (Hct) value, mean corpuscular volume (MCV), activities of serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), glucose level, serum total protein and globulin were found in rats treated with the high dose of tartrazine. In general, there was appreciable improvement after the recovery period. The Low observed adverse effect level (LOAEL) for the test compound tartrazine is found to be 10 mg/Kg bw.
13 week subchronic toxicity study was conducted by Maekawa (1987) to evaluate the toxic nature of the test compound tartrazine (RA CAS no 1934-21-0). The test compound was administered in drinking water at a dose level of 0(control), 0.3, 0.6, 1.25, 2.5 or 5.0% (w/v) (0, 150, 300, 625, 1250 or 2500 mg/Kg bw). All rats were observed daily and clinical signs and deaths were recorded. Body weights were measured once a week. At the end of the study, all survivors were killed and organs and tissues were taken for gross and microscopical examination. The probable maximum tolerable dose of tartrazine in the drinking-water was found to be between 1.25 and 2.5%. Based on the results observed, the low observed adverse effect level (LOAEL) for the test compound tartrazine is found to be 2.5 % (1250 mg/Kg bw).
The weight of evidence data suggests that the test chemical 4-aminoazobenzene-3,4'-disulphonic acid (CAS no 101 -50 -8) is not toxic upon repeated dose exposure.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The No Observed Adverse Effect Level (NOAEL) for the test compound 4-aminoazobenzene-3,4'-disulphonic acid is found to be 792.237976074 mg/Kg bw (actual dose ingested) using rats.
Justification for classification or non-classification
Based on the data predicted for the target cas and data from read across suggests that the test chemical 4-aminoazobenzene-3,4'-disulphonic acid (CAS no 101 -50 -8) is not toxic upon repeated dose exposure by the oral route.
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