Registration Dossier
Registration Dossier
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EC number: 201-837-6 | CAS number: 88-51-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD method used
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Preliminary examination of OECD TG407:
Four male and four female rats were used for the 14 day- Preliminary Examination conducted prior to the OECD 407 repeated dose study entered in chapter 7.5.1. - GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-aminotoluene-3-sulphonic acid
- EC Number:
- 201-831-3
- EC Name:
- 4-aminotoluene-3-sulphonic acid
- Cas Number:
- 88-44-8
- Molecular formula:
- C7H9NO3S
- IUPAC Name:
- 2-amino-5-methylbenzenesulfonic acid
- Details on test material:
- Mitsuboshi Chemical Co., Ltd.: purity >99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were 5 weeks old.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil, 0.5ml/100g bw
- Doses:
- 0, 100, 250, 500, 100, 2000 mg/kg/day
- No. of animals per sex per dose:
- 4
- Control animals:
- yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Neither mortalities nor clinical symptoms of toxicity were seen. Necropsy revealed enlarged cecum at 2000 mg/kg bw/day.
- Mortality:
- None of the animals died.
- Clinical signs:
- No clinical effects were seen at up to 2000 mg/kg bw/day.
- Body weight:
- No effects on body weight were seen at up to 2000 mg/kg bw/day.
- Gross pathology:
- At necropsy, no effects on organ weight was observed at up to 2000 mg/kg bw/day.
Pathological examination revealed enlargement of the cecum in all animals treated with 2000 mg/kg bw/day. - Other findings:
- No effects on food consumption, urinary parameters, hematology and clinical chemistry were observed at up to 2000 mg/kg bw/day.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 (and LD0) was > 2000 mg/kg.
Main toxicological effect was enlargement of cecum in both sexes at 2000 mg/kg bw/day
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