2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given, comparable to guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide

EC Number:

229-355-1

EC Name:

2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide

Cas Number:

6486-23-3

Molecular formula:

C16H12Cl2N4O4

IUPAC Name:

2-[(4-chloro-2-nitrophenyl)diazenyl]-N-(2-chlorophenyl)-3-oxobutanamide

Test material form:

solid: nanoform, no surface treatment

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in house breeding, SPF rats
- Weight at study initiation: mean: 104 g (84-118g)
- Fasting period before study: yes, 16 hours
- Diet: Standard ALTROMIN R (Altromin GmbH, Lage/Lippe, Germany)
- Water: tap water

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 12.5%

- the highest concentration (15000 mg/kg bw) was applied in two portions à 7500 mg/kg bw within one hour

Doses:

4000, 6300, 10000, 15000 mg/kg bw

No. of animals per sex per dose:

10 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data, but necropsy of animals which died

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

8 285 mg/kg bw

Based on:

test mat.

Mortality:

4000 mg/kg bw: 0/10
6300 mg/kg bw: 1/10
10000 mg/kg bw: 9/10
15000 mg/kg bw: 10/10

the animals died within 1.5 and 24 hours after application

Clinical signs:

other: clinical signs of animals which died: - imbalance, accelerated respiration, prone position, paralysis of the limbs - the pigment was excreted via faeces

Gross pathology:

- no macroscopic anomalies in the animals

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Single application of the test item to Wistar rats by gavage resulted in an LD50 of 8252 mg/kg bw. The test item has not to be classified for acute oral toxicity.

Executive summary:

Acute toxicity of the test item has been investigated in female SPF-Wistar rats (10 animals per dose group). The animals received 4000, 6300, 10000 or 15000 mg test item / kg bw by gavage (12.5% suspension in sesame oil). The post observation period was 7 days. The mortality was 0/10, 1/10, 9/10 and 10/10 in the 4000, 6300, 10000 or 15000 mg / kg bw dose group. The LD50 was calculated to be 8252 mg/kg bw. Animals which died showed imbalance, accelerated respiration, prone position and paralysis of the limbs. No pathologic findings were observed at necropsy.