Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(6-sulphonato-2-naphthyl)azo]naphthalene-2-sulphonate]

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:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

FAT 11178/B

IUPAC Name:

FAT 11178/B

Details on test material:

- Name of test material (as cited in study report): FAT 11178/B
- Physical state: powder

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Exp. Toxicology Sisseln, CIBA-Geigy Ltd.
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: mean males: 163 ± 4.3 g; mean females: 166 ± 2.5 g
- Fasting period before study: overnight
- Housing: in groups of 5 in Macrolon cages (type 3)
- Diet: ad libitum (NAFAG, Gossau SG)
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water containing 2 % carboxymethylcellulose + 0.1 % Tween 80

Details on oral exposure:

DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males, 4 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Physical condition and rate of deaths were monitored throughout the whole observation period. Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality

Mortality:

No mortality.

Clinical signs:

other: Clinical signs included sedation, dyspnoea, ruffled fur, diarrhoea and a curved body position. The animals recovered within 7 days.

Gross pathology:

No gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:

other: non classified according to CLP Regulation

Conclusions:

The acute oral LD50 of the TS in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg. The test material has therefore practically no acute toxicity to the rat by this route of administration.

Executive summary:

Five male and four female young adult rats (Tif: RAIf, SPF) were given a single dose of 5000 mg/kg bw in 20 ml/ kg bw. The vehicle was water containing 2% CMC and 0.1% Tween 80. No animal died. Dyspnea, exophthalmus, ruffled fur, diarrhea and curved body position were observed. The animals recovered within six days and did no show any symptoms until the end of the observation period of 14 days. At autopsy, no deviations from normal morphology were found in surviving animals. The test item contained 89% active ingredient as well as 10% urea.