2-[[4-(diethylamino)-2-methylphenyl]azo]-5-nitrobenzene-1,3-dicarbonitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 October 1987 to 25 November 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity"

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[[4-(diethylamino)-2-methylphenyl]azo]-5-nitrobenzene-1,3-dicarbonitrile

EC Number:

284-395-7

EC Name:

2-[[4-(diethylamino)-2-methylphenyl]azo]-5-nitrobenzene-1,3-dicarbonitrile

Cas Number:

84870-65-5

Molecular formula:

C19H18N6O2

IUPAC Name:

2-[[4-(diethylamino)-2-methylphenyl]azo]-5-nitrobenzene-1,3-dicarbonitrile

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Six male and six female Sprague-Dawley CFY strain rats were supplied by Interfauna (UK) Limited, Wyton, Huntingdon, Cambridgeshire. At the start of the main study the males weighed 124 - 139g, and the females 120 - 140g, and were approximately five to eight weeks old. After a minimum acclimatisation period of five days the animals were selected at random and given a unique number within the study by ear punching and a number written on a cage card.
The animals were housed in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding. With the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
The animal room was maintained at a temperature of 19 – 22 °C and relative humidity of 45 - 65%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

For the purpose of the study the test material was ground to a fine powder using a mortar and pestle and freshly prepared, as required, as a solution/suspension at the appropriate concentration in arachis oil B.P.
Dose volume: 10 mL/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

Range finding study: 2 (1 male/1 female)
Main Study: 10 (5 male/5 female)

Control animals:

no

Details on study design:

All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
Animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Deaths and evidence of overt toxicity were recorded at each observation.
Individual bodyweights were recorded on the day of treatment (day 0), and on days 7 and 14.
All animals were subjected to gross necropsy examination for any macroscopic abnormalities. No tissues were retained.

Statistics:

Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made. Clinical observations, bodyweight and necropsy records were examined for any adverse but non-lethal effects resulting from treatment.

Results and discussion

Preliminary study:

No mortalities.
Using the mortality data given in the above table the oral LD50 of the test material was considered to be greater than 5000 mg/kg. This dose level was therefore used for the main study.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity during the study period.

Gross pathology:

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

Other findings:

Light blue-coloured staining of the general body hair was noted in all animals one to six days after treatment.

Any other information on results incl. tables

Mortality Data

The mortality data are summarised as follows:

DOSE LEVEL mg/kg	SEX	DEATHS ON DAY:									TOTAL DEATHS
		0	1	2	3	4	5	6	7	8-14
5000	MALE	0	0	0	0	0	0	0	0	0	0/10
	FEMALE	0	0	0	0	0	0	0	0	0

 

INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN THE MAIN STUDY

TEST MATERIAL: DISPERSIONSBLAU F-60 768

DOSE LEVEL mg/kg	ANIMAL NUMBER & SEX	HOURS AFTER DOSING		DAYS AFTER DOSING
		1	4	1	2	3	4	5	6	7	9	8	10	11	12	13	14
5000	3-0 MALE	0	0	0 St	0 St	0 St	0 St	0 St	0 St	0	0	0	0	0	0	0	0
	3-1 MALE	0	0	0 St	0 St	0 St	0 St	0 St	0 St	0	0	0	0	0	0	0	0
	3-2 MALE	0	0	0 St	0 St	0 St	0 St	0 St	0 St	0	0	0	0	0	0	0	0
	3-3 MALE	0	0	0 St	0 St	0 St	0 St	0 St	0 St	0	0	0	0	0	0	0	0
	3-4 MALE	0	0	0 St	0 St	0 St	0 St	0 St	0 St	0	0	0	0	0	0	0	0
	4-0 FEMALE	0	0	0 St	0 St	0 St	0 St	0 St	0 St	0	0	0	0	0	0	0	0
	4-1 FEMALE	0	0	0 St	0 St	0 St	0 St	0 St	0 St	0	0	0	0	0	0	0	0
	4-2 FEMALE	0	0	0 St	0 St	0 St	0 St	0 St	0 St	0	0	0	0	0	0	0	0
	4-3 FEMALE	0	0	0 St	0 St	0 St	0 St	0 St	0 St	0	0	0	0	0	0	0	0
	4-4 FEMALE	0	0	0 St	0 St	0 St	0 St	0 St	0 St	0	0	0	0	0	0	0	0

St = light blue-coloured staining of the general body hair                         0 = no systemic toxicity detected

 

INDIVIDUAL BODYWEIGHTS AND WEEKLY BODYWEIGHT INCREASES IN THE MAIN STUDY

TEST MATERIAL: DISPERSIONSBLAU F-60 768

DOSE LEVEL mg/kg	ANIMAL NUMBER & SEX	BODYWEIGHT (g) AT DAY			INCREMENT (g) DURING WEEK
		0	7	14	1	2
5000	3-0 MALE	126	195	245	69	50
	3-1 MALE	128	198	260	70	62
	3-2 MALE	139	216	274	77	58
	3-3 MALE	136	206	265	70	59
	3-4 MALE	124	185	244	61	59
	4-0 FEMALE	120	170	192	50	22
	4-1 FEMALE	126	180	202	54	22
	4-2 FEMALE	130	194	234	64	40
	4-3 FEMALE	124	190	228	66	38
	4-4 FEMALE	140	211	235	71	24

 

INDIVIDUAL NECROPSY FINDINGS IN THE MAIN STUDY

TEST MATERIAL: DISPERSIOSBLAU F-60 768

DOSE LEVEL mg/kg	ANIMAL NUMBER & SEX	MACROSCOPIC OBSERVATIONS
5000	3-0 MALE	Killed day 14	No abnormalities detected
	3-1 MALE	Killed day 14	No abnormalities detected
	3-2 MALE	Killed day 14	No abnormalities detected
	3-3 MALE	Killed day 14	No abnormalities detected
	3-4 MALE	Killed day 14	No abnormalities detected
	4-0 FEMALE	Killed day 14	No abnormalities detected
	4-1 FEMALE	Killed day 14	No abnormalities detected
	4-2 FEMALE	Killed day 14	No abnormalities detected
	4-3 FEMALE	Killed day 14	No abnormalities detected
	4-4 FEMALE	Killed day 14	No abnormalities detected

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test material, Dispersionsblau F 60 768 to the rat was found to be greater than 5000 mg/kg bw.
The substance is not classifiable according to CLP criteria.

Executive summary:

A study was performed to determine the acute oral median lethal dose (LD50) of the test material, administered as a solution/suspension in arachis oil B.P., in the Sprague-Dawley CFY strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401 “Acute Oral Toxicity”.

 

Following a range-finding study, a single group of ten fasted animals (five males and five females), was given a single oral dose of test material preparation at a dose level of 5000 mg/kg bodyweight.

 

There were no deaths. No signs of systemic toxicity were noted during the study period. All animals showed light blue-coloured staining of the general body hair one to six days after treatment.

 

All animals showed expected gains in bodyweight over the study period.

 

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

 

The acute oral median lethal dose (LD50) of the test material, DISPERSIONSBLAU F-60 768, to the rat was found to be greater than 5000 mg/kg bodyweight.

The substance is not classified according to CLP criteria.