2-[[4-[(2-cyanoethyl)ethylamino]phenyl]azo]-5-nitrobenzonitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October from 05 to 31, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disperse Red 073

IUPAC Name:

Disperse Red 073

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin & Kingman Ltd., Grimston, Aldborough, Hull, U.K.
- Age at study initiation: approximately five to eight weeks old.
- Weight at study initiation: males weighed 134 - 141 g and the females 129 - 152 g.
- Fasting period before study: overnight fast immediately before dosing.
- Housing: animals were housed in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding.
- Diet: Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, ad libitum.
- Water: drinking water, ad libitum.
- Acclimation period: at least five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 24 °C
- Relative humidity: 49 - 65 %
- Air changes: approximately 15 changes per hour.
- Photoperiod: 12 hours light and 12 hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

- Concentration: 250 mg/ml
- Dose volume: 10 ml/kg x 2

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

Five males and five females

Details on study design:

MAIN STUDY
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: deaths and overt signs of toxicity were recorded 30 min, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded on the day of treatment (day 0) and on days 7 and 14.
- Necropsy of survivors performed: at the end of the study the animals were killed by cervical dislocation and subjected to gross necropsy examination for any macroscopic abnormalities. The procedure consisted of opening the abdominal and thoracic cavities and examining all major organs. The macroscopic appearance of abnormal organs if present was recorded. No tissues were retained.

RANGE-FINDING STUDY
- Concentrations: 200, 2000, 5000 mg/kg bw
- Number of animals per dose: 1 male and 1 female.
- Administration: animals treated with 2000 and 200 mg/kg were dosed once only by gavage using a metal cannula attached to a graduated syringe. Due to the nature of the test material, animals in the 5000 mg/kg dose group received two doses with an interval of one hour between the doses.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths occurred.

Clinical signs:

No signs of systemic toxicity were noted during the study.

Body weight:

All animals showed expected gain in bodyweight during the study.

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulatin (EC) No 1272/2008

Conclusions:

LD50 (male and female) > 5000 mg/kg bw

Executive summary:

A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401. Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material preparation, administered as a suspension in arachis oil B.P. at a dose level of 5000 mg/kg bodyweight.

There were no deaths. No signs of systemic toxicity were noted during the study. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy of animals killed at the end of the study.

Conclusion

LD50 (male and female) > 5000 mg/kg bw