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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
Endpoint summary
Administrative data
Description of key information
The substance do not show any short term toxicity effect on any of the route of exposure that is oral, dermal and inhalation.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- 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. - 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).
- 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. - 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- K1 level data obtained by OECD testing
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age : 8 to 10 weeks
Sex : Male and female
Body weight range : 200±20g
Identification : By cage tag and corresponding colour body marking
Acclimatization : The healthy wistar albino rats selected for study acclimatized to standard laboratory condition for period of one week under close Veterinary supervision.
Randomization : After acclimation and veterinary examination randomly selected in groups of three females.
Randomization: After acclimation and Veterinary examination all the animals randomly divided into two groups and each group having five male and five female rats.
Nutritional conditions: Animals were fasted overnight prior to test and food was offered three hours after dosing. - Type of coverage:
- open
- Vehicle:
- water
- Remarks:
- distilled water
- Details on dermal exposure:
- The test drug 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid applied dermally under impervious gauze at the dose level of 2000 mg/kg b.wt in Group-I, II respectively. The test compound held in contact for period of 24 hrs. After 24 hrs, test compound was removed and wash with luke warm water and observed for clinical signs of intoxication and mortality at different time interval for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7th and 14th (post treatment). The necropsy was performed on all animals which was died during the study or were sacrificed at termination of the study.
- Duration of exposure:
- 24hrs.
- Doses:
- 2000 mg/kg bwt
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The test substance was applied uniformly over an exposed area of skin. The test compound was held in contact with the skin with an impervious dressing secured in place with an adhesive tape. The animals were then housed individually in cages with a collar around the neck in order to avoid the ingestion of the test compound. After 24 hours, the dressing was removed and the site of application was cleaned with lukewarm water wiping the test compound.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- dissolved
- Remarks on result:
- other: non toxic in wistar albino rats
- Mortality:
- The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any mortality at the tested dose level of 2000 mg/kg b.wt in wistar albino rats throughout the period of observation.
- Clinical signs:
- other: The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not elicit any clinical signs of toxicity entire the observation period. No skin reaction was observed after 24th hrs. of patch removal.
- Gross pathology:
- 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. - 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 dermal route. The acute dermal LD50 of test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid observed to be more than 2000 mg/kg b.wt.
- Executive summary:
Mortality:
The test compound, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid,did not produce any mortality at the tested dose level of 2000 mg/kg b.wt in Wistar albino rats throughout the period of observation.
Clinical signs:
The test compound, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid,did not elicit any clinical signs of toxicity entire the observation period. No skin reaction was observed after 24thhrs. of patch removal.
Body weight:
The body weight of animals treated with test compound observed on days 7th& 14thshowed normal gain in body as compared to day 0 (pre-treatment)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- K1 level data obtained by OECD testing
Additional information
Acute Oral toxicity:
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. Moreover Wistar albino rats treated with the test substance did not produce any mortality throughout the period of observation.
Regarding the 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. Also the necropsy finding has been normal as mentioned below;
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.
Acute dermal Toxicity :
The test compound, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid,did not produce any mortality at the tested dose level of 2000 mg/kg b.wt in Wistar albino rats throughout the period of observation. The test compound, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid,did not elicit any clinical signs of toxicity entire the observation period. No skin reaction was observed after 24thhrs. of patch removal. Moreover, the body weight of animals treated with test compound observed on days 7th& 14thshowed normal gain in body as compared to day 0 (pre-treatment).
Acute inhalation toxicity :
In accordance with column 2 of Annex VIII, this end point was considered for waiver since given the very low vapour pressure of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid; exposure of humans via inhalation is highly unlikely and their is negligible possibility of exposure to aerosols, particles or droplets of an inhalable size.
Justification for selection of acute toxicity – oral endpoint
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.
Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of Annex VIII, this end point was considered for waiver since given the very low vapour pressure of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid; exposure of humans via inhalation is highly unlikely and their is negligible possibility of exposure to aerosols, particles or droplets of an inhalable size.
Justification for selection of acute toxicity – dermal endpoint
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 dermal route. The acute dermal LD50 of test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid observed to be more than 2000 mg/kg b.wt.
Justification for classification or non-classification
Since the substance, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid, do not show any short term toxicity effect on any of the route of exposure that is oral, dermal and inhalation. So, it cannot be considered for classification as per the C&L criteria.
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