2-[N-(2-cyanoethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]anilino]ethyl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 30, 1985 to May 15, 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Male and female rats were administered the test substance at 5000 mg/kg bw by oral gavage. The application was followed by a 14-d observation period and thereafter the animals were sacrificed.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[N-(2-cyanoethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]anilino]ethyl acetate

EC Number:

226-070-4

EC Name:

2-[N-(2-cyanoethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]anilino]ethyl acetate

Cas Number:

5261-31-4

Molecular formula:

C19H17Cl2N5O4

IUPAC Name:

2-[N-(2-cyanoethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]anilino]ethyl acetate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Breeder: Winkelmann, Borchen
Age: ca. 8 weeks old
Body weight: 153 -157g
Temperature and relative humidity: 22 +/- 1.5°C and 60 +/- 5%, respectively
Light period: 12 h light - 12 h dark
Feed: Altromin R 1324

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

water

Details on oral exposure:

The test substance was diluted into water and administered at a constant rate by gavage. Animals did not have access to feed and water from 16 h before to 4 h after application.

Doses:

20 mL/kg (5000 mg/kg bw)

No. of animals per sex per dose:

5

Details on study design:

This was followed by a 14-d observation period. At the end of the study, animals were sacrified and an anatomo-pathological examination was realised.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the study period

Clinical signs:

other: No clinical symptoms were observed

Gross pathology:

After the anatomo-pathoogical examination, no signs of toxicity were detected

Other findings:

-

Applicant's summary and conclusion

Conclusions:

Under the study conditions, the oral LD50 of the test substance in rats was established at >5000 mg/kg bw.

Executive summary:

A study was conducted to determine the oral acute toxicity of the test substance (guideline not specified) in rats. Male and female rats were administered the test substance at a concentration of 5000 mg/kg bw by oral gavage. The application was followed by a 14 -d observation period. At the end of the study, the animals were sacrificed and a gross pathological examination was conducted. No deaths, no clinical symptoms during the observation period and no signs of toxicity at necropsy were recorded. Under the study conditions, the oral LD50 of the test substance in rats was established at >5000 mg/kg bw (Ramm, 1985).