N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well documented study report, which meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Company guideline previous to OECD guideline implementation that is similar to OECD 401

Deviations:

not applicable

Principles of method if other than guideline:

A 25% suspension of the test substance in sesame oil in a dosage of 15000 mg/kg bw was administered by single application via gavage. Post administrational observation period was 14d.

GLP compliance:

no

Remarks:

- prior to GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide

EC Number:

247-820-7

EC Name:

N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide

Cas Number:

26576-46-5

Molecular formula:

C11H11N3O3

IUPAC Name:

3-oxo-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)butanamide

Details on test material:

- Name of test material (as cited in study report): Acetolon

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Source: Hoechst AG
Number of animals: 10 females
Weight: 94 - 102 g (mean weight: 98 g)

Diet: Altromin 1324 (Altrogge, Lage/Lippe), ad libitum
Water: Tap water, ad libitum

Housing: Plastic cages with wood shavings

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%

Doses:

15000 mg/kg

No. of animals per sex per dose:

10 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- No diet 16 hrs before until 2 hrs after application of test item.

- Frequency of observations and weighing: weekly

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Mortality:

No

Clinical signs:

other: No findigs.

Gross pathology:

No abnormal findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

LD50: >15000 mg/kg bw

Executive summary:

Acetolon was tested for acute oral toxicity following a protocol similar to OECD 401 (limit test). A single dose of 15000 mg/kg bw was tested by administering 25% Acetolon suspended in sesame oil once per oral gavage to 10 female Wistar rats. Median body weight was 98 g. 16 hrs before until 2 hrs after administration food was withdrawn. Post administrational observation time was 14 d. During this time rats were fed with standard diet and tap water.

During the observation period lethality was 0 out of 10 animals . These findings demonstrate that LD50 exceeds 15000 mg/kg bw.