1,3-dihydro-5-nitro-2H-benzimidazol-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-03-11 to 1986-03-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed OECD and GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

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

Test material information

Constituent 1

Reference substance name:

1,3-dihydro-5-nitro-2H-benzimidazol-2-one

EC Number:

202-282-2

EC Name:

1,3-dihydro-5-nitro-2H-benzimidazol-2-one

Cas Number:

93-84-5

Molecular formula:

C7H5N3O3

IUPAC Name:

5-nitro-1,3-dihydro-2H-benzimidazol-2-one

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Doses:

Dose: 5000 mg/kg body weight
Concentration: 25% (w/v)
Application: 20 ml/kg body weight

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

limit test

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

During the 14 days of post application observation no death occured in male or female animals.

Clinical signs:

other: Some clinical signs occured in female animals 1 day post application and 1-2 days in male animals. After the third day after the application none of the animals continued to show clinical symptoms.

Gross pathology:

Two female animals showed brighter kidneys. There were no findings with the remaining animals.

Any other information on results incl. tables

No lethality was observed in the test group during the observation period of 14 days following the application of the test item.

Beside endpoint lethality additional findings (ethyiologic and clinically signs) were recorded, which disappeared latest on day 3 p.a.

2 female but no male specimen showed brightened kidney during necroscopic inspection, no further macroscopic findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

LD50: >5000 mg/kg bw.

Executive summary:

The testing of the acute oral toxicity of Nitrolon on 5,5 Wistar-rats showed no mortality. The test item was applied in a dose of 5000 mg/ kg bw. Beside unspecific symptoms (ethiologic) some minor clinical signs were recorded which disappeared latest at day three p.a. At necroscopy beside lightened kiudney in two female specimen no other macroscopic signs were observed.