5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid

EC Number:

276-344-2

EC Name:

5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid

Cas Number:

72102-84-2

Molecular formula:

C12H10N6O4

IUPAC Name:

5-[(1E)-2-(6-methyl-2-oxo-2,3-dihydro-1H-1,3-benzodiazol-5-yl)diazen-1-yl]-1,3-diazinane-2,4,6-trione

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- lot/batch No.of test material: LV 86

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: raised on the premises
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: males: 165-179 g; females: 164-169 g
- Fasting period before study: overnight
- Housing: the animals were housed in groups of 5 in Macrolon cages (type 3)
- Diet (e.g. ad libitum): ad libitum rat food - NAFAG, Gossau SG
- Water (e.g. ad libitum): ad libitum water
- Acclimation period: a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): a 10 hours light cycle day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2%

Details on oral exposure:

DOSE VOLUME APPLIED: 20 mL/kg

DOSAGE PREPARATION (if unusual):
The test substance was suspended. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Rationale for dose selection: no higher doses were possible

Doses:

4000, 5000, 6000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days; physical condition and rate of deaths were monitored throughout the whole observation period
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: Sedation, Dyspnoea, exopthalmos, ruffled fur, body position (curved). The surviving animals recovered within 10 days.

Gross pathology:

No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met