Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzamide, 3-amino-N-[4-(aminocarbonyl)phenyl]-4-methoxy-, hydrochloride
EC Number:
618-990-3
Cas Number:
939961-06-5
Molecular formula:
C15H15N3O3xClH
IUPAC Name:
Benzamide, 3-amino-N-[4-(aminocarbonyl)phenyl]-4-methoxy-, hydrochloride

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, kastengrund, SPF-breeding
- Age at study initiation: males: about 7 weeks; females: about 8 weeks
- Weight at study initiation: males: 177 - 193 grams; females: 175 - 186 grams
- Fasting period before study: about 16 hours
- Housing: in completely air conditioned rooms in macrolon cages in groups of 5 animals
- Diet: Ratten diät Altromin 1324, Altromin GmbH, Lage/Lippe, ad libitum
- Water: tap water from plastic bottles, ad libitum
- Acclimation period: not required since breeding under the same conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 55+-20
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: potatoe starch (2% in deionized water)
Details on oral exposure:
see below
Doses:
Dosis Concentration application-volume number of animals
(mg/kg bw) (% (w/v)) (ml/kg bw) males females
2000 20 10 5 5
No. of animals per sex per dose:
5 males 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, body weight

Results and discussion

Preliminary study:
1 male and 1 female animal for each dose.
Doses: 500, 1000, 2000 mg/kg bw.
No mortality, only unspecific symptoms and irregular aspirate
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Sex:
male
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
Clinical signs:
Squatting posture, flanks pinched in, increased respiration.
Two dayas after the application these symptoms were completely reversible.
Body weight:
No effect on the development of the body weight
Gross pathology:
After the observation period the animals did not show any macroscopic findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Due to the LD50>2000 mg/kg bw the substance is not subject for classification for acute oral toxicity.
Executive summary:

The substance was tested for acute oral toxicity to the Wistar-rat according to OECD guideline 401. A pre-test was performed with one male and one female rat for each dose of 500, 1000 and 2000 mg/kg bw. There was no mortality in this pre-test. For the main test 5 male and 5 female animals were administered a single dose of 2000 mg/kg bw by gavage. No mortality occured up to the observation period of 14 days but unspecific symptoms such as squatting posture, pinched in flanks and increased respiration could be noticed. Two dayas after the application these symptoms were completely reversible.

There was no effect on the development of the body weight and after section of the killed animals no macroscopic findings were present.

The LD50 is therefore greater than 2000 mg/kg bw