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

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[4-(aminocarbonyl)phenyl]-4-methoxy-3-nitrobenzamide
EC Number:
298-790-7
EC Name:
N-[4-(aminocarbonyl)phenyl]-4-methoxy-3-nitrobenzamide
Cas Number:
93839-20-4
Molecular formula:
C15H13N3O5
IUPAC Name:
N-(4-carbamoylphenyl)-4-methoxy-3-nitrobenzamide

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: Hoe: WISKf(SPF71)
- Source: Hoechst AG, company breeding colony
- Age at study initiation: males about 7 weeks; females about 8 weeks
- Mean weight at study initiation: males: 194+-2 g; femals: 171+-5 g
- Fasting period before study: 16 hours
- Housing: in macrolon cages in completely air conditioned rooms; 5 animals per cage
- Diet: Altromin 1324 ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 50+-20

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 2% starch mucilage
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 mals and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice a day and weighing: once a week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
males and females showed squatting posture and irregular respiration. These symptomes disappeared 2 days after dosing
Body weight:
normal development
Gross pathology:
no effects
Other findings:
no otherf findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50: > 2000 mg/ kg bw
Executive summary:

The substance was tested for acute oral toxicity in the Wistar rat (5 mals and 5 females) according to OECD 401 (limit test) using a dose of 2000 mg/kg bw. No lethality occured, but irregular respiration and squatting posture was observed. These symptoms disappeared 2 days after dosing. The development of the body weight was normal. Necropsy revealed no abnormal findings. LD50 was above 2000 mg/ kg bw.