Registration Dossier
Registration Dossier
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EC number: 205-175-9 | CAS number: 135-11-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 10th to May 28th, 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-(p-aminoanilino)-3-nitrobenzenesulphonic acid
- EC Number:
- 205-175-9
- EC Name:
- 4-(p-aminoanilino)-3-nitrobenzenesulphonic acid
- Cas Number:
- 135-11-5
- Molecular formula:
- C12H11N3O5S
- IUPAC Name:
- 4-[(4-aminophenyl)amino]-3-nitrobenzene-1-sulfonic acid
- Test material form:
- solid
- Details on test material:
- Sample name: 4-amino-2'-nitro-4'-sulfo-1,1'-diphenylamin (ANSD)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- KFM-Han
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG CH 4414 Fuellinsdorf / AG Switzerland
- Age at study initiation: approx 9 weeks
- Weight at study initiation: males 178-210 g, females 154-177 g
- Acclimation period: one week under test conditions
- Housing: groups of 5 in Makrolon type-3 cages with wire mesh tops and standardized soft wood bedding
- Diet (e.g. ad libitum): pelleted standard Kliba 24/343
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Light cycle: 12 h/d
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Doses:
- 1000 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 per sex
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality five times during the first day and daily thereafter; bodyweight at day of administration and days 7 and 14
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality was observed
- Gross pathology:
- The following macroscopic organ changes were observed: 5000 mg/kg: no pathologlc changes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (male, female) > 5000 mg/kg bw
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