Tetrasodium 2-[[8-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]benzoyl]amino]-1-hydroxy-3,6-disulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Remarks:

source of read across

Adequacy of study:

key study

Study period:

From September 21 to October 12, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted March 22,1996

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd
- Age at study initiation: females 10 weeks old; males 8 weeks old.
- Weight at study initiation: females 177 - 184 g; males 205 - 213 g.
- Fasting period before study: fasting for approximately 16 to 16.5 hours. Food was provided again approximately 3 hours after dosing.
- Housing: groups of three in Makrolon type4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: pelleted standard Kliba 3433, batch no. 39/99, rat maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst), available ad libitum.
- Water: community tap water from Itingen, available ad libitum.
- Acclimation period: 6 days, under laboratory conditions, after health examination. Only animals without any visible signs of ilrness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 40 - 70 %
- Air changes: 10-15 air changes per hour.
- Photoperiod: 12 hour light/dark cycle.
- Other: recorded music was played for approximately 8 hours during the light period.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- Application volume / kg body weight: 10 ml

TEST ARTICLE PREPARATION
The test article was placed into a glass beaker on a tared Mettler balance and the vehicle (bidistilled water) was added. A weight by volume dilution was prepared using a magnetic stirrer as homogenizer. Homogeneity of the test article in the vehicle was maintained during treatment.
The preparation was made shortly before each dosing.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females or 3 males

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: four times during test day 1 and once daily during days 2 - 15.
- Frequency of weighing: on test day 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: necropsies were performed by experienced prosectors. At the end of the observation period all animals were sacrificed by intraperitoneal injection of NARCOREN (Rhöne Merieux GmbH, D-88471 Laupheim). The animals were examined macroscopically and all abnormalities recorded. Thereafter, they were discarded.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No death occurred during the study.

Clinical signs:

No clinical signs were noted during the observation period.

Body weight:

The body weight of the animals was within the range commonly recorded for this strain and age.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

LD50 (male and female) > 2000 mg/kg bw

Executive summary:

Two groups, each using three female or three male Hanlbm: WIST (SPF) rats, were treated withtest item at 2000 mg/kg by oral gavage. The test article was suspended in vehicle (bi-distilled water) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day I prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

No death occurred during the study. No clinical signs were noted during the observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

Conclusion

LD50 (male and female) > 2000 mg/kg bw