2-[(4-chloro-2-nitrophenyl)azo]-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

Study period:

From 16 MAR 1977 to 30 MAR 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

study was performed previous to GLP implementation

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide

EC Number:

235-462-4

EC Name:

2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide

Cas Number:

12236-62-3

Molecular formula:

C17H13ClN6O5

IUPAC Name:

2-[(4-chloro-2-nitrophenyl)diazenyl]-3-oxo-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)butanamide

Test material form:

solid: bulk

Specific details on test material used for the study:

Pigment Orange 36

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 97 -104 g
- Fasting period before study: 16 h before dosing, 2 h after
- Diet: ALTROMIN 1324 (Altroge, Lage, Germany), ad libitum
- Water: tap water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 %

Doses:

15 000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no animal died within the observation period

Gross pathology:

- animals killed at the end of the observation period showed no macroscopically visible changes.

Other findings:

After application animals showed ruffled fur and accelerated respiration. Test substance was excreted via the faeces.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Single application of 15000 mg/kg bw of the test substance did not cause lethality in female Wistar rats during the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw.

Executive summary:

Female Wistar rats (n=10) were subjected to test acute oral toxicity. No animal died after single administration of 15000 mg/kg bw of the test substance by gavage (14 day observation period), thus leading to a LD50 > 15000 mg/kg bw.