5-amino-6-methyl-1,3-dihydrobenzoimidazol-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-03-25 - 1998-05-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted March 22, 1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 1996

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

428-410-9

EC Name:

-

Cas Number:

67014-36-2

Molecular formula:

C8 H9 N3 O

IUPAC Name:

5-amino-6-methyl-2,3-dihydro-1H-1,3-benzodiazol-2-one

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 7 - 9 weeks
- Weight at study initiation:
- Fasting period before study:
- Housing: 3 animals per sex and cage (polycarbonate cages)
- Diet: standard pelleted laboratory diet, ad libitum (Carfil Quality BVBA, Oud-Turnhout, Belgium)
- Water: tap water, ad libitum
- Acclimation period: at least 5 days before treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:

200, 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Viability: twice daily; Body weights: on Days 1, 8, 15; Clinical signs: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic findings

Statistics:

Not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The incidence of mortality for males was 3/3 (2000 mg/kg), 0/3 (200 mg/kg) and for females 1/3 (2000 mg/kg), 0/3 (200 mg/kg).

Clinical signs:

other: 2000 mg/kg: - Lethargy, hunched posture, uncoordinated movements, piloerection, red staining of the nose, laboured respiration and emaciation was noted among the animals that died. - Lethargy, hunched posture, uncoordinated movements among the surviving

Gross pathology:

Beginning of autolysis, enlarged kidneys and reduction in size of spleen, thymus and seminal vesicles was found among the animals that died during the study. No abnormalities were found at macroscopic post mortem examination of the surviving animals.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU