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

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

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

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

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

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.

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:

-

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).

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From January 13, 1993 to January 27, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

"Richtlinie 84/449/EWG (Amtsblatt der Europäischen Gemeinschaften Nr. L 251 vom 19.09.1984, S.93)"

Deviations:

not specified

Principles of method if other than guideline:

"Richtlinie 84/449/EWG (Amtsblatt der Europäischen Gemeinschaften Nr. L 251 vom 19.09.1984, S.93)"

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Breeder: Winckelmann, Borchen
Acclimatization period: at least 5 d
Age: 8-10 weeks old
Body weight: 174-192 g
Temperature and relative humidity: 22 +/- 2°C and 55 +/- 5%, respectively
Light period: 12h light/12h dark
Diet and water: Altromin 1324 and tap water, ad libitum

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 (20 mL/kg bw) by gavage. Animals did not have access to feed and water from 16 h before to 4 h after application.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

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.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One male died but cause of death was unascertained

Clinical signs:

other: None

Gross pathology:

In the deceased male, a generalized discolouration of the subcutaneous connective tissue was observed. The stomach was filled with a yellow-orange mass and the lungs were reddeded.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the study conditions, the oral LD50 of the test substance in rats was established at >2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to EU Method B.1 bis, in compliance with GLP. Male and female rats were administered the test substance at a concentration of 2000 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 gross pathological examination was conducted. One male died during the study period, but clinical signs of toxicity were not observed in this animal. No clinical signs were detected in the other animals. No treatment-related effects were observed on the body weight. In the deceased male, a generalized discolouration of the subcutaneous connective tissue was observed, the stomach was filled with a yellow-orange mass and the lungs were reddened. The necropsy of the other animals did not show any toxicity. Under the study conditions, the oral LD50 of the test substance in rats was established at >2000 mg/kg bw (Bomhard, 1993).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A study was conducted to determine the acute oral toxicity of the test substance according to EU Method B.1 bis, in compliance with GLP. Male and female rats were administered the test substance at a concentration of 2000 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 gross pathological examination was conducted. One male died during the study period, but clinical signs of toxicity were not observed in this animal. No clinical signs were detected in the other animals. No treatment-related effects were observed on the body weight. In the deceased male, a generalized discolouration of the subcutaneous connective tissue was observed, the stomach was filled with a yellow-orange mass and the lungs were reddened. The necropsy of the other animals did not show any toxicity. Under the study conditions, the oral LD50 of the test substance in rats was established at >2000 mg/kg bw (Bomhard, 1993).

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 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).

Justification for classification or non-classification

Based on the results of acute toxicity studies in the rat, the test substance does not require classification according to CLP (EC 1272/2008) criteria.