[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl]trimethylammonium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: experimnental result on similar substance

Adequacy of study:

key study

Study period:

From December 12, 1978 to January 10, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

Study conducted before 1981

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Basic Red 018 Chloride - Similar Substance 01

IUPAC Name:

Basic Red 018 Chloride - Similar Substance 01

Test material form:

other: solid

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 to 8 weeks old
- Fasting period before study: overnight before treatment
- Housing: housed in groups of 5 in Macrolon cages
- Diet: NAFAG, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Amount of vehicle : 10, 20 ml/kg
The test item was suspended. Before treatment the suspension was homogeneously suspended with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

Doses (mg/kg bw) : 1000, 2000, 3000, 5000
Volume (ml/kg bw): 10, 20

No. of animals per sex per dose:

5 per sex per dose

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 122 mg/kg bw

Based on:

test mat.

Remarks on result:

other: effect level in a range of 1656-2619 mg/kg bw

Mortality:

(1000 mg/kg bw) no deaths; (2000 mg/kg bw) 4 death; (3000 mg/kg bw) 9 death; (5000 mg/kg bw) all animals were found dead

Clinical signs:

Sedation, Dyspnoea, Exophtalmos, Ruffled fur, Body Position (Curved) in all the concentration tested.
Diarrhoea was observed at doses of 1000, 2000 and 3000 mg/kg bw.
Convultions were observed at the dose of 5000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 (male/female) = 2122 mg/kg bw

Executive summary:

Method

The test substance was tested for Acute Oral Toxicity on rats according to a method similar to the OECD Guideline 401. Five animals per sex per dose were administered by gavage with the test item at four different concentrations ( 1000, 2000, 3000 and 5000 mg/kg bw).

Observations

During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages. Animals fasted overnight were treated by oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period.

During the test Sedation, Dyspnoea, Exophtalmos, Ruffled fur, Body Position (Curved) in all the concentration tested. Diarrhoea was observed at doses of 1000, 2000 and 3000 mg/kg bw. Convultions were observed at the dose of 5000 mg/kg bw.

At 1000 mg/kg bw no deaths occurred and at the maximum dose (5000 mg/kg bw) all the animals were found dead, at the other concentrations the following number of animals were found dead: 4 animals at 2000 mg/kg bw and 9 animals at 3000 mg/kg bw.

Conclusion

LD50 (male/female) = 2122 mg/kg bw