Registration Dossier
Registration Dossier
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EC number: 201-830-8 | CAS number: 88-43-7
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:
- data from handbook or collection of data
- Justification for type of information:
- Data is from Secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Acute oral toxicity of 3-Aminobenzenesulfonic acid in rats
- Author:
- J-CHECK
- Year:
- 2 010
- Bibliographic source:
- Ministry of Health, Labour and Welfare", "Ministry of the Environment" and "National Institute of Technology and Evaluation, J-CHECK - (2010)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Acute oral toxicity of 3-Aminobenzenesulfonic acid in rats
- GLP compliance:
- not specified
- Test type:
- other: Acute oral toxicity
- Limit test:
- no
Test material
- Reference substance name:
- 3-aminobenzenesulphonic acid
- EC Number:
- 204-473-6
- EC Name:
- 3-aminobenzenesulphonic acid
- Cas Number:
- 121-47-1
- Molecular formula:
- C6H7NO3S
- IUPAC Name:
- 3-aminobenzenesulfonic acid
- Details on test material:
- - Name of test material (as cited in study report): 3-Aminobenzenesulfonic acid
- Molecular formula (if other than submission substance): C6H7NO3S
- Molecular weight (if other than submission substance): 173.20 g/mole
- Substance type: Organic
- Physical state: No data available
Purity 98.6%
- Impurities (identity and concentrations): 1.4 %
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 3-Aminobenzenesulfonic acid
- Molecular formula (if other than submission substance): C6H7NO3S
- Molecular weight (if other than submission substance): 173.20 g/mole
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Doses:
- 500, 1000, 2000 mg/kg
- No. of animals per sex per dose:
- Total: 30
500 mg/kg: 5 male, 5 female
1000 mg/kg: 5 male, 5 female
2000 mg/kg: 5 male, 5 female - Control animals:
- not specified
- Details on study design:
- No data available
- Statistics:
- No data available
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No effect on survival, clinical sign, body weight, gross pathology and histopathology
- Mortality:
- No mortality was observed in treated male and female rats.
- Clinical signs:
- other: When treated with 500 and 1000 mg/kg, diarrhea with soft feces on the administration day and the following day, and yellow-discolored urine on the administration day were observed in treated male and female rats.
- Gross pathology:
- No gross pathological changes were observed in treated male and female rats.
- Other findings:
- No histopathological changes were observed in treated male and female rats.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- LD50 was considered to be > 2000 mg/kg bw when Crj:CD (SD) male and female rat were treated with 3-Aminobenzenesulfonic acid orally.
- Executive summary:
In a acute oral toxicity study,Crj:CD (SD) male and female rats were treated with 3-Aminobenzenesulfonic acid in the concentration of 500, 1000, 2000 mg/kg orally. No effect on survival and body weight were observed in treated rats. Diarrhea with soft feces on the administration day and the following day, and yellow-discolored urine on the administration day were observed at 500 and 1000 mg/kg treated male and female rats. In addition, no gross pathological and histopathological changes were observed in treated male and female rats. Therefore,LD50 was considered to be> 2000 mg/kg bw whenCrj:CD (SD) male and female rat were treated with 3-Aminobenzenesulfonic acid orally.
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