Registration Dossier
Registration Dossier
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EC number: 219-169-9 | CAS number: 2379-81-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- March 28, 1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The substance has been tested according to a procedure similar to accpeted guideline but the content of the active ingredient in the test substance is low.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N,N'-(10,15,16,17-tetrahydro-5,10,15,17-tetraoxo-5H-dinaphtho[2,3-a:2',3'-i]carbazole-6,9-diyl)bis(benzamide)
- EC Number:
- 219-169-9
- EC Name:
- N,N'-(10,15,16,17-tetrahydro-5,10,15,17-tetraoxo-5H-dinaphtho[2,3-a:2',3'-i]carbazole-6,9-diyl)bis(benzamide)
- Cas Number:
- 2379-81-9
- Molecular formula:
- C42H23N3O6
- IUPAC Name:
- N,N'-(10,15,16,17-tetrahydro-5,10,15,17-tetraoxo-5H-dinaphtho[2,3-a:2',3'-i]carbazole-6,9-diyl)bis(benzamide)
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif RAI f
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY - Basle
- Weight at study initiation: from 90 to 100 grams
- Fasting period before study: animals fasted overnight before treatment
- Housing: animals housed in groups of 5 in Macrolon cages (type 3)
- Diet (e.g. ad libitum): ad libitum a standard diet of pellets - No. 890, Nafag Gossau SG
- Water (e.g. ad libitum): ad libitum
- Acclimation period: for a minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22 °C
- Humidity (%): 50 - 60 %
- Photoperiod (hrs dark / hrs light): 14 hours light cycle day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10, 25, 30 % - Doses:
- 1000, 3000, 10000 and 15000 mg/kg bw
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: at the beginning and at the end
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 000 mg/kg bw
- Based on:
- not specified
- Mortality:
- 1 male died at 15000 mg/kg bw
- Clinical signs:
- other: At 10000 mg/kg bw: reduction in spontaneous motility, ataxia, hyperventilation. Symptoms lasting >6 hours. After 24 hours no symptoms. At 15000 mg/kg bw: ditto, dyspnoea, muscular hypotonia, diarrhea
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 > 15000 mg/kg bw
- Executive summary:
Method
The acute oral LD50 of the test substance in rats of both sexes was observed over a period of 15 days.
Four doses were administered by gavage: 1000, 3000, 10000 and 15000 mg/kg bw.
Results
Under test conditions the LD50 was found to be > 15000 mg/kg bw.
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