Registration Dossier
Registration Dossier
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EC number: 228-412-8 | CAS number: 6262-07-3
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: Study well documented, test procedure in accordance with OECD methods, meets generally accepted scientific principles, acceptable for assessment. Not GLP compliant.
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:
- Similar substance 01
- IUPAC Name:
- Similar substance 01
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: 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:
- Compound passed through the gastro intestinal tract within 12 hours of administration and some was still visible in the faeces after 24 hours.
- Body weight:
- No data.
- Gross pathology:
- No change in any organs and tissues.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The tested item was found to be non toxic for oral exposure with a LD50 > 5000 mg/kg bw.
- Executive summary:
The results show no toxicity with a LD 50 value > 5000 mg/kg.
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