Registration Dossier
Registration Dossier
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EC number: 204-473-6 | CAS number: 121-47-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- Guidelines for 28-Day Repeat Dose Toxicity Testing for Chemicals (Japan)
- GLP compliance:
- yes
- 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-aminobenzene-1-sulfonic acid
- Details on test material:
- - Name of test material (as cited in study report): 3-Aminobenzenesulfonic acid
- Purity : 98.6%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% CMC-Na solution
- Duration of treatment / exposure:
- 28 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300, 1000 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 7 (100, 300 mg/kg)
14 (0, 1000 mg/kg; 7 animals were used for 14 day recovery)) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Terminal kill: Day 29 or 43
Examinations
- Observations and examinations performed and frequency:
- CLINICAL SIGNS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
HAEMATOLOGY: Yes
BLOOD CHEMISTRY: Yes
URINALYSIS: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
ORGAN WEIGHT: YES
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Details on results:
- Water consumption increased in males of the 1000 mg/kg group during the late phase of administration. Decreased urinary pH values were noted in both sexes receiving 1000 mg/kg. These changes disappeared by 14 days after withdrawal. No effects were observed in terms of clinical signs, body weighs, food consumption, hematology, blood chemistry, organ weights, and autopsy or histopathology findings.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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