Trisodium 1-amino-4-[[3-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

276-481-8

EC Name:

Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

72214-18-7

Molecular formula:

C32H26ClN7O11S3.3Na

IUPAC Name:

Reaction mass of Trisodium 1-amino-4-[[3-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and Trisodium 1-amino-4-[[3-[[4-chloro-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Test material form:

solid: particulate/powder

Remarks:

granulate

Specific details on test material used for the study:

FAT 41001/D

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: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation:7-8 weeks
- Weight at study initiation: 178-219 g
- Housing: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin).
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%):55+-15
- Air changes (per hr):approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 250 and 200 mg/mL
- Amount of vehicle (if gavage): 20 and 10 mL/kg bw
- Dose levels: 5000, 2000 mg/kg bw.

MAXIMUM DOSE VOLUME APPLIED:
20 mL/kg bw

Doses:

5000, 2000 mg/kg bw.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of clinical observations: daily
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, signs and symptoms, body weight, necropsies

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 - < 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured at 2000 mg/kg bw, besides one male rat, which died due to intratracheal intubation.
At 5000 mg/kg bw all male and 3 female rats died on Day1. The remaining two female rats died on Day 2.

Clinical signs:

other: Dyspnoea, exophthalmus, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, diarrhea was noted during the first two days as well as a blue staining of the eyes and extremities. The surviving animals recovere

Gross pathology:

In the high dose group all animals had a blue stained carcass. No other findings were made at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 value in rats via oral administration of test substance was found to lie between 2000 and 5000 mg/kg bw.

Executive summary:

Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 was determined :

LD50 in rats of both sexes is between 2000 and 5000 mg/kg bw

According to the company standard the test substance has a slight acute toxicity when administered orally to the albino rat.