2-[(2-cyanoethyl)[4-[(6-nitrobenzothiazol-2-yl)azo]phenyl]amino]ethyl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July - August, 1979

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:

1979

Materials and methods

Principles of method if other than guideline:

Rat dosed by gavage; 14-day observation period.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disperse Red 177

IUPAC Name:

Disperse Red 177

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 104 - 129 g
- Fasting period before study: overnight

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Remarks:

aqueous methylcellulose (1 %)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40 % w/v
- Amount of vehicle: 12.5 ml/kg bw

Doses:

0 (control) and 5000 mg/kg

No. of animals per sex per dose:

5/sex/dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One female treated rat died within 3 hours of dosing. Autopsy revealed congestion of the lungs, pallor of the liver, kidneys and spleen and dosage material within the thoracic cavity.

Clinical signs:

other: Signs of reaction to treatment, observed shortly after dosing, included pilo-erection, abnormal body carriage (hunched posture) and abnormal gait (waddling). These signs were accompanied by lethargy, pallor of the extremities and ptosis in one female rat

Gross pathology:

Normal terminal autopsy findings.

Other findings:

Recovery of the survivors, as iudged by external appearance and behaviour, was apparently complete within 3 days of dosing.

Any other information on results incl. tables

Signs of reaction to treatment

signs	no. showing signs / no. dosed
	dose mg/kg
	0	5000
pilo-erection	10/10	10/10
abnormal body carriage (hunched posture)	0/10	10/10
abnormal gait (waddling)	0/10	10/10
lethargy	0/10	1/10
pallor of extremities	0/10	1/10
ptosis	0/10	1/10

Applicant's summary and conclusion

Interpretation of results:

other: not classified within the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 greater than 5000 mg/kg.

Executive summary:

Method

Acute oral toxicity in rats exposed by oral route; a 14 -day observation period follows dosing. Symptoms and section findings were recorded.

Results

Death occurred within 3 hours from dosing in one female rat, showing congestion of lungs, pallor of liver, kidneys and spleen, dosage material within thoracic cavity. Signs of treatment reaction included pilo-erection, hunched posture, waddling. In additon, lethargy, pallor of extremities and ptosis were noted in one female prior to death. Recovery of survivors was apparently complete within 3 days, based on normal bodyweight gains; normal terminal autopsy findings were also noted.

LD50 value was greater than 5000 mg/kg.