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Registration Dossier
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EC number: 222-111-5 | CAS number: 3351-05-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate
- EC Number:
- 222-111-5
- EC Name:
- Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate
- Cas Number:
- 3351-05-1
- Molecular formula:
- C32H23N5O6S2.2Na
- IUPAC Name:
- disodium 8-(phenylamino)-5-[(1E)-2-{4-[(1E)-2-(3-sulfonatophenyl)diazen-1-yl]naphthalen-1-yl}diazen-1-yl]naphthalene-1-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Weight at study initiation: average male weight 196 g, average female weight 158 g- Age: 7 weeks- Fasting period before study: 22 h - Housing: single animale per cage- Diet: commercial pelleted diet (Oakes Special Diet with added Vit. C) ad libitum- Water: tap water ad libitum ENVIRONMENTAL CONDITIONS- Temperature (°C): 21 ± 2- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- Single dose: 25% of solution of teh compound in tap water was administrated with a single dose by gavage to rate which had been fasted for 18 hours at a rate of 20ml/kg equivalent to 5000 mg/kg of the compound.
- Control animals:
- not specified
- Statistics:
- Not applicable.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality
- Clinical signs:
- other: Compound passed through the gastro intestinal tract within 12 hours of administration and some was still visible in the faeces after 24 hours.
- Gross pathology:
- No change in any organs and tissues.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 > 5000 mg/kg bw.
- Executive summary:
The results show no toxicity with a LD 50 value > 5000 mg/kg.
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