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EC number: 205-080-2 | CAS number: 132-87-6
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- Acute oral toxicity study of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid in Wistar albino rats
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
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 g/mole
- InChI: 1S/C8H10N2O5S/c1-4(11)10-7-3-5(16(13,14)15)2-6(9)8(7)12/h2-3,12H,9H2,1H3,(H,10,11)(H,13,14,15)
- Substance Type: Organic
- Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- Molecular formula : C8H10N2O5S
- Molecular weight : 246.24 g/mole
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- 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.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25 °C
- Humidity (%): 40-60 %
- Air changes (per hr): 10-15 air change per hour
- Photoperiod (hrs dark / hrs light): 12 hour light and 12 hour dark
IN-LIFE DATES: From: 22/10/2012
To:24/11/2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0 and 2000 mg/kg bw
- Amount of vehicle (if gavage):10 ml/kg
- Justification for choice of vehicle:distilled water
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual):3-acetamido-5-amino-4-hydroxybenzenesulphonic acid was dissolved in distilled water to obtain final concentration of 200 mg/lm.
- Doses:
- 0 and 2000 mg/kg bw
- No. of animals per sex per dose:
- Total: 9
0 mg/kg bw: 3 female
2000 mg/kg bw: 3 female (Group II)
2000 mg/kg bw: 3 female (Group III) - 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:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- 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:
- 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.
- Body weight:
- All the animals treated with 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 .
- Gross pathology:
- Skin and hair coat was observed wet, all external orifices were normal and no gross pathological changes were observed in treated rat.
Any other information on results incl. tables
Clinical sign and Mortality
Group I (Vehicle control) Dose: 10 ml/kg b.wt
Parameters |
Incidence of clinical signs observed after dosing |
Mortality |
||||||||||||||
Day 0 |
Day |
|||||||||||||||
Min |
Hour |
|||||||||||||||
30 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total* |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Clinical sign |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = No clinical sign (Normal)
+ = Clinical sign
Clinical sign and Mortality
Group II Dose: 2000 mg/kg b.wt
Parameters |
Incidence of clinical signs observed after dosing |
Mortality |
||||||||||||||
Day 0 |
Day |
|||||||||||||||
Min |
Hour |
|||||||||||||||
30 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total* |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Clinical sign |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = Normal
+ = Mild
++ = Moderate
+++ = High
++++ = Severe
Clinical sign and Mortality
Group III Dose: 2000 mg/kg b.wt
Parameters |
Incidence of clinical signs observed after dosing |
Mortality |
||||||||||||||
Day 0 |
Day |
|||||||||||||||
Min |
Hour |
|||||||||||||||
30 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total* |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Clinical sign |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = Normal
+ = Mild
++ = Moderate
+++ = High
++++ = Severe
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- 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 cutoff of test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid found to be more than 5000 mg/kg b.wt. - Executive summary:
In acute oral toxicity study, Wistar female rat were treated with 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid in the concentration of 0 (Group I) and 2000 mg/kg bw (Group II and III) in distilled water orally by gavage. No mortality and any clinical signs of toxicity were observed in treated rat at 2000 mg/kg bw. Normal gain in body weight and Skin and hair coat was observed wet, all external orifices were normal and no gross pathological changes were observed in treated rat. Therefore, LD50 cutoff was considered to be 5000 mg/kg bw when Wistar female rat were treated with 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid orally.
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