3-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]propiononitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Principles of method if other than guideline:

"Up and down method with small samples", K.A. Brownlee, J.L. Dodges and M. Rosblatt, J. Amer. Stat. Assoc. 48 (1953).

GLP compliance:

no

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disperse Red 050

IUPAC Name:

Disperse Red 050

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 5-6 weeks
- Average weight at study initiation: 162 (M), 145 (F)
- Fasting period before study: 18 h
- Housing: singly
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Photoperiod (dark / light): 12 h / 12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Preliminary study:

A preliminary range finding study suggested that the acute oral median lethal dose (LD50) would be less than 5000 mg/kg bw.
In the range finding study, deaths occurred between 5 and 131 hours after dosing. 1 M and 1 F showed piloerection, lacrymation and salivation.
At autopsy, no treatment induced changes were recorded.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 980 mg/kg bw

Based on:

test mat.

95% CL:

> 3 620 - < 4 380

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 592 mg/kg bw

Based on:

act. ingr.

Mortality:

Deaths occurred between 5 and 48 h after dosing.

Clinical signs:

No symptoms

Gross pathology:

No treatment induced changes at autopsy.

Any other information on results incl. tables

Series 1

exp.	dose mg/kg	log dose	dead animal?
0	5000	0.6990	y
1	4300	0.6337	y
2	3700	0.5674	y
3	3200	0.5011	y
4	2700	0.4348	y
5	2300	0.3685

Series 2

exp.	dose mg/kg	log dose	dead animal?
0	5000	0.6990	y
1	4300	0.6337	y
2	3700	0.5674	n
3	4300	0.6337	n
4	5000	0.6990	n
5	5800	0.7653

Series 3

exp.	dose mg/kg	log dose	dead animal?
0	5000	0.6990	y
1	4300	0.6337	y
2	3700	0.5674	n
3	4300	0.6337	y
4	3700	0.5674	n
5	4300	0.6337

Series 4

exp.	dose mg/kg	log dose	dead animal?
0	5000	0.6990	n
1	5800	0.7653	y
2	5000	0.6990	y
3	4300	0.6337	y
4	3700	0.5674	y
5	3200	0.5011

Applicant's summary and conclusion

Interpretation of results:

other: cat. 4 according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 = 3980 mg/kg, equivalent to 1592 mg/kg as active ingredient.

Executive summary:

Method

Up and down method with small samples as described in J. Amer. Stat. Assoc. 48 (1953). Preliminary range finding study and main study were carried out on male and female rats, dosed by gavage.

Results

LD50 of 3980 mg/kg (95 % CL of 3620 - 4380 mg/kg). Deaths occurred between 5 and 48 h.

LD50 of 1592 mg/kg as active ingredient.