N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 1980 to 1981-02-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

5000 mg/kg bw, instead of 2000 mg/kg bw, was administered as limit dose

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

EC Number:

255-473-8

EC Name:

N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Cas Number:

41642-51-7

Molecular formula:

C20H19N7O3

IUPAC Name:

N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Test material form:

solid: particulate/powder

Details on test material:

- State of aggregation: solid/powder
- Melting point: > 100 °C
- pH: 6.5 (at 2.0 g/L H2O)
- Bulk density: ~0.5 g/cm³

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: males: 9 weeks, females: 14 weeks
- Weight at study initiation: males: 164 to 171 g, females: 161 to 171 g
- Fasting period before study: 16 hours before and 4 hours after treatment
- Housing: Animals were kept in Makrolon cages type III on dust-free wood granules
- Diet (e.g. ad libitum): Altromin R 1324 from Altromin GmbH, Lage, Germany; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 30 mL/kg bw

DOSAGE PREPARATION: The test item was diluted in water at room temperature

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: On the day of application animals were observed multiple times. During the 14 days observation period animals were observed twice daily (once at weekend and holidays). Type, onset, duration and intensity of clinical symptoms were examined
- Frequency of weighing: Animals were weighed on the day of application, after one week and after 14 days
- Necropsy of survivors performed: yes, on a random basis

Statistics:

not applicable

Results and discussion

Preliminary study:

n.a.

Effect levels

Effect levels 1

Key result

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

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 350 mg/kg bw

Based on:

act. ingr.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality observed

Clinical signs:

other: No effects observed

Gross pathology:

No effects observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study in rats, no mortality has been observed at a dose of 5000 mg/kg bw. Hence, the LD50 value can be considered to be greater than 5000 mg/kg bw. The substance is not classifiable according to CLP criteria.

Executive summary:

In an acute oral toxicity study, young adult Wistar rats (5/sex) were given a single oral dose of the test item diluted in water at a dose of 5000 mg/kg bw and observed for 14 days. All animals survived until the end of the study. No clinical signs and/or effects on body weight were observed. Gross pathology performed on certain animals revealed no adverse signs. Based on the results, the oral LD50 in both male and female rats can be considered to be greater than 5000 mg/kg bw.

Based on these results, no classification for acute oral toxicity is warranted according to CLP criteria.