Registration Dossier

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:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): p-Nitrobenzoylaminobenzamid TTR

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
Squatting posture, flanks pinched in, coat bristling, irregular respiration, stilted and uncoordinated gait
All symptomes were reversible one day after application.
Body weight:
Body weight gain not impaired
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.