Registration Dossier
Registration Dossier
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EC number: 298-791-2 | CAS number: 93839-21-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-[4-(aminocarbonyl)phenyl]-4-nitrobenzamide
- EC Number:
- 298-791-2
- EC Name:
- N-[4-(aminocarbonyl)phenyl]-4-nitrobenzamide
- Cas Number:
- 93839-21-5
- Molecular formula:
- C14H11N3O4
- IUPAC Name:
- N-(4-carbamoylphenyl)-4-nitrobenzamide
- Details on test material:
- - Name of test material (as cited in study report): p-Nitrobenzoylaminobenzamid TTR
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG breeding colony
- Age at study initiation: males: 7 weeeks; females: 8 weeks
- Weight at study initiation (mean): males: 186g; females: 177g
- Fasting period before study: 16 hours
- Housing: in fully air conditioned rooms in macrolon cages with groups of 5 animals
- Diet: rat diet Altromin 1324, ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: potato starch 2 % in water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% (w/v)
- Amount of vehicle (if gavage): 10 ml/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: twice a day (weekends: once a day) and weighing: day 1, day 8, day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, lethality - Statistics:
- no since limit test
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality during the 14 days observation period
- Clinical signs:
- other: Squatting posture, flanks pinched in, coat bristling, irregular respiration, stilted and uncoordinated gait All symptomes were reversible one day after application.
- Gross pathology:
- No macroscopic abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- LD50: > 2000 mg/kg bw
- Executive summary:
Acute orale toxicity of N-(4-carbamoylphenyl)-4-nitrobenzamide was tested in male and female Wistar rats according to OECD 401 (limit test) at a concentration of 2000 mg/kg bw. No mortality occured. LD50: > 2000 mg/kg bw.
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