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EC number: 254-879-2 | CAS number: 40306-75-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- EC Number:
- 254-879-2
- EC Name:
- 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- Cas Number:
- 40306-75-0
- Molecular formula:
- C8H10N2O5S
- IUPAC Name:
- 3-acetamido-5-amino-4-hydroxybenzenesulfonic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material : 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- Molecular formula : C8H10N2O5S
- Molecular weight : 246.24
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age : 7 to 9 weeks
Sex : Female, nulliparous and non pregnant. It has been observed that females are generally more sensitive than males to toxic effects
Body weight range : 200±20g
Identification : By cage tag and corresponding colour body marking
Acclimatization : One week in experimental room after veterinary examination.
Randomization : After acclimation and veterinary examination randomly selected in groups of three females.
Nutritional conditions : Fasted overnight prior to treatment. Food was offered three hours after dosing.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Remarks:
- distilled water
- Details on oral exposure:
- The toxicity of the 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid following oral administration was assessed. The test drug was given orally via oral cannula at the dose level 2000 mg/kg b.wt in Group-II & Group III respectively. Whereas, distilled water was given in same manner as test group(Group I). The rats were observed for incidence of mortality and signs of intoxication for 14 days after the administration of test article. The body weight of all the animals was observed weekly on day 0 (pre treatment), 7th and 14th (post treatment). Necropsy was carried out on all the animals which died during the study or surviving animals were sacrificed at the end of the study to observe any gross pathological changes.
- Doses:
- 2000 mg/kg b.wt
- No. of animals per sex per dose:
- Three female rats were used per step for each dose level.
- Control animals:
- yes
- Details on study design:
- The test compound was administered by oral route by using of oral cannula at the dose volume of 10 ml/kg b.wt. The treated animals were closely observed for clinical signs of intoxication, first 4 hours and every 1 hrs interval for 24 hrs after dosing and thereafter twice a day for 14 days. All the rats were observed at least twice daily to observe any clinical signs or behavioral changes. The body weight of all the animals was observed weekly on day 0 (pre treatment), 7th and 14th (post treatment).
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: non toxic in wistar albino rats
- Mortality:
- Wistar albino rats treated with the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any mortality throughout the period of observation.
- Clinical signs:
- other: The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not show any clinical signs of toxicity at the tested dose level of 2000 mg/kg b.wt throughout the period of observation.
- Gross pathology:
- Pathology
1.Necropsy
Necropsy was carried out on all the animals that died during the study or surviving animals were sacrificed at the end of the study to observe any gross pathological changes.
2.Histopathological study
The organ showing gross pathological change during necropsy subjected for histopathological study.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- From the result obtained from present investigation it can be concluded that the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid is acutely non toxic upto the tested dose level of 2000 mg/kg b.wt in wistar albino rats when applied by oral route.
The acute oral LD50 of test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid found to be more than 2000 mg/kg b.wt. - Executive summary:
Body weights
All the animals treated with the substance, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid, at the dose level of 2000 mg/kg b.wt showed normal gain in body weight as compared to control group.
MORTALITY
Wistar albino rats treated with the test substance did not produce any mortality throughout the period of observation.
CLINICAL SIGNS
The test compound, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid, did not show any clinical signs of toxicity at the tested dose level of 2000 mg/kg b.wt throughout the period of observation.
NECROPSY FINDING
A. EXTERNAL
i. Skin-Skin and hair coat was observed wet.
ii. All external orifices-Normal
B. INTERNAL
I. Subcutaneous- No change was observed.
ii. Superficial and deep lymph nodes-No change in mesenteric lymph node.
ABDOMINAL CAVITY
i. Opening and general examination-In the abdominal cavity all the organs were present in normal position.
ii. Spleen-Normal upto highest tested dose level 2000 mg/kg b.wt.
iii. Digestive system-No gross changes were observed in stomach and intestine upto highest tested dose level 2000 mg/kg b.wt.
iv. Liver and biliary ducts-No gross pathological changes were observed
v. Excretory system-No gross pathological changes were observed upto highest tested dose level 2000 mg/kg b.wt.
vi. Adrenal-Observed normal.
vii. Male/female genital organs –Showed normal colour, consistency and no inflammatory changes upto highest tested dose level 2000 mg/kg b.wt.
THORACIC CAVITY
i. Opening and general examination-Thoracic cavity was found to be normal without any fluid, mucous or blood etc.
ii. Lungs-observed normal.
iii. Heart-No changes were observed in color and consistency. Heart found normal upto highest tested dose level 2000 mg/kg b.wt.
iv. Thyroid-Normal in shape, size and surface upto highest tested dose level 2000 mg/kg b.wt.
CRANIAL CAVITY- Brain-Normal in shape and size.
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