Trisodium trihydrogen 5,5',5''-(1,3,5-triazine-2,4,6-triyltriimino)tris[5-sulphonatosalicylate]

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:

guideline study with acceptable restrictions

Remarks:

well performed and documented guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium trihydrogen 5,5',5''-(1,3,5-triazine-2,4,6-triyltriimino)tris[5-sulphonatosalicylate]

EC Number:

279-091-6

EC Name:

Trisodium trihydrogen 5,5',5''-(1,3,5-triazine-2,4,6-triyltriimino)tris[5-sulphonatosalicylate]

Cas Number:

79135-90-3

Molecular formula:

C24H18N6O18S3.3Na

IUPAC Name:

trisodium 3-({4,6-bis[(3-carboxy-2-hydroxy-5-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-5-carboxy-4-hydroxybenzene-1-sulfonate

Test animals

Species:

rat

Strain:

other: KFM-Han. Wistar, SPF-quality

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Mauderin AG, 4414 Fuellingsdorf, Switzerland
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 154 - 192 g (males); 153 - 168 g (females)
- Fasting period before study: overnight
- Housing: Macrolon cages (type 3) in groups of five
- Diet: peletted standard Kliba 24/343/1 rat maintenance diet (Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland); ad libitum
- Water: tap water; quality according to Schweiz Lebensmittelbuch; ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12
- Room air conditioned

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2 % aqueous solution of carboxymethylcellulose, sodium salt

Details on oral exposure:

VEHICLE
- a dilution of the test compound was prepared using a homogenizer (Ultra-Turrax) and kept homogenous during treatment using a magnetic stirrer
- Application volume: 10 mL/kg bw at 1000 mg/kg bw; 20 mL at 5000 mg/kg bw

Doses:

1000 mg/kg bw
5000 mg/kg/bw

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: five times at day 1; daily during days 2 - 14
- Frequency of weighing: on test days 1, 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no animals died within the 14 day observation period

Mortality:

no deaths occurred during the study

Clinical signs:

other: slightly developed effects were observed in both sexes: sedation and exophthalmos on day 1; dyspnoea and curved body position until day 5 and ruffled fur until day 10.

Gross pathology:

animals killed at the end of the observation period showed no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance was administered orally to Wistar rats of both sexes at doses of 1000 mg/kg bw and 5000 mg/kg bw. No deaths were observed during the 14 day observation period, resulting in a LD50 > 5000 mg/kg bw.

Executive summary:

Male and female rats were subjected to test acute oral toxicity according to OECD TG 401. The test item was administered at dose leves of 1000 mg/kg bw and 5000 mg/kg bw to 5 male and 5 female rats respectively. During the 14 days observation period no animals died and there were no ab normalities found in necropsy, thus leading to an LD50 > 5000 mg/kg bw.

Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.