Registration Dossier
Registration Dossier
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EC number: 241-734-3 | CAS number: 17741-63-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N,N'-[6,13-diacetamido-2,9-diethoxy-3,10-triphenodioxazinediyl]bis(benzamide)
- EC Number:
- 241-734-3
- EC Name:
- N,N'-[6,13-diacetamido-2,9-diethoxy-3,10-triphenodioxazinediyl]bis(benzamide)
- Cas Number:
- 17741-63-8
- Molecular formula:
- C40H34N6O8
- IUPAC Name:
- N,N'-(6,13-diacetamido-2,9-diethoxy[1,4]benzoxazino[2,3-b]phenoxazine-3,10-diyl)dibenzamide
- Test material form:
- solid: nanoform
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CERJ., 53940 Le Genest
- Weight at study initiation: 220-250 g (males), 170-200 g (females)
- Fasting period before study: 18 hours
- Housing : 10 animals per Makrolon SAFI 60/40 cm cage, with dust free white wood shavings
- Diet: UAR A04, 18 to 25 g (depending on age and weight of the animal)
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 40-60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 g/100 mL
MAXIMUM DOSE VOLUME APPLIED: 2.0 mL/100 g - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: animals were observed continuously on the first day after administration, they then remained in daily observation for 14 days
- Necropsy performed: yes, animals that died during the first day (8 hours) were dissected and their major organs (liver, spleen, kidneys, stomach, lung, heart) examined macroscopically. All organs with obvious macroscopic lesions were retained for further histological examination if necessary.
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.
- Clinical signs:
- other: Immediately after administration of Violet Cromophtal B, animals are lethargic and their fur is ruffled.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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