tetrasodium 4-{4-[(9,10-dioxo-4-{[4-(2-sulfophenoxy)phenyl]amino}-9,10-dihydroanthracen-1-yl)amino]phenoxy}benzene-1-sulfonate 4-{4-[(9,10-dioxo-4-{[4-(4-sulfophenoxy)phenyl]amino}-9,10-dihydroanthracen-1-yl)amino]phenoxy}benzene-1-sulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

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:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

Study predates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Disodium 2-{4-[(9,10-dioxo-4-{[4-(4-sulfonatophenoxy)phenyl]amino}-9,10-dihydroanthracen-1-yl)amino]phenoxy}benzenesulfonate and Disodium 4,4'-[(9,10-dioxo-9,10-dihydroanthracene-1,4-diyl)bis(iminobenzene-4,1-diyloxy)]dibenzenesulfonate

EC Number:

941-784-2

Molecular formula:

C38H26N2O10S2.2Na

IUPAC Name:

Reaction mass of Disodium 2-{4-[(9,10-dioxo-4-{[4-(4-sulfonatophenoxy)phenyl]amino}-9,10-dihydroanthracen-1-yl)amino]phenoxy}benzenesulfonate and Disodium 4,4'-[(9,10-dioxo-9,10-dihydroanthracene-1,4-diyl)bis(iminobenzene-4,1-diyloxy)]dibenzenesulfonate

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): FAT 21030/C
- Physical state: Solid

Specific details on test material used for the study:

FAT 21030/C

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Healthy random bred rats of the Tif: RAIf (SPF) strain (7 to 8 weeks old) raised on the premises were used for the experiment. They were kept at a room temperature of 22±2 °C, at a relative humidity of 55±10 % and on a 10 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days.

During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3), individually marked with picric acid.

Administration / exposure

Route of administration:

other: Oral intubation

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

- Volume: 10 and 20 ml/kg.
- DOSAGE PREPARATION: FAT 21030/C was suspended in polyethylene glycol (PEG 400). Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

1000, 3000, 4000 and 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

After administration of the compound, the animals were observed for 14 days. Physical condition and rate of deaths were monitored throughout the whole obseravtion period. At the end of the observation period, surviving animals were killed and an autopsy performed.

Statistics:

LD50 including 95% confidence limits were calculated by the logit model.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the 14 day observation period.

Clinical signs:

other: Sedation, dyspnoea, exophtalmos, ruffled fur, diarrhoea and curved body position were observed with all dose groups. The animals recovered within 7 days.

Gross pathology:

No substance related gross organ changes were observed in dead and killed animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of FAT 21030/C in rats was considered to be >5000 mg/kg bw.

Executive summary:

The LD50 of FAT 21030/C was evaluated in a study conducted using methodology similar to OECD Guideline 401. Groups of rats (each containing 5 males and 5 females) were administered FAT 21030/C at 1000, 3000, 4000 and 5000 mg/kg bw. The test item was suspended in polyethylene glycol (PEG 400) and administered by oral intubation.

No deaths occurred in animals that received doses of 1000, 3000 and 5000 mg/kg bw, however one female was found dead at 4000 mg/kg bw during the 14 day observation period. Sedation, dyspnoea, exophtalmos, ruffled fur, diarrhoea and curved body position were observed with all dose groups. The animals recovered within 7 days. At autopsy, no substance related gross organ changes were seen.

Based on the above findings, the acute oral LD50 of FAT 21030/C observed over a period of 14 days was considered to be >5000 mg/kg bw.