Trisodium 2,4-diamino-3,5-bis-[4-(2-sulfonatoethoxy)sulfonyl)phenylazo]benzenesulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

N0V. 14 to DEC.19, 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

GLP compliance:

yes (incl. QA statement)

Remarks:

German GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

FAT45'176/A

IUPAC Name:

FAT45'176/A

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Code number: FAT45'176/A
Batch No.: WP2/96
Purity: ca. 60 %
Appearance: orange-brown solid powder
Storage: room temperature
Expiration date: 11/2004

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: WP2/96
- Expiration date of the lot/batch: November 30, 2004

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature at about 20 °C; away from direct sunlight.
- Stability of the test substance in the solvent/vehicle: Stable in bi-distilled water for at least 48 h at 20 °C

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, 4414 Füllinsdorf / Switzerland
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: males: 8 weeks; females: 10 weeks
- Weight at study initiation: males: 197.1 - 218.5 g; females: 174.8 - 186.3 g
- Fasting period before study: 17 h
- Housing: Groups of five in Makrol on type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet : Pelleted standard Kliba 343, Batch nos. 78/96 and 81/96 rat maintenance diet (Kliba Mühlen AG, CH-4303 Kaiseraugst) available ad libitum
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: One week under laboratory conditions, after health
examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 h artificial fluorescent light/12 h dark

IN-LIFE DATES: From: 21-N0V-1996 to 05-DEC-1996

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

bi-distilled water

Details on oral exposure:

The animals received a single dose of the test article on a mg/kg body weight basis by oral gavage following fasting for approximately 17 h, but with free access to water. Food was provided again approximately 3 hours after dosing.

Doses:

2000 mg/kg body weight (10 mL/kg body weight)

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

The test item was administration to a group of 5 male and 5 female rats by oral gavage, at the single dose of 2000 mg/kg body weight. The application volume was 10 mL/kg body weight. The animals were examined and mortality, viability and clinical signs were recorded. Body weights were taken on test day 1 (pre-administration), 8 and 15 for surviving animals. Necropsies were performed by experienced prosectors. At the end of the observation period all animals were sacrificed. The animals were examined macroscopicaliy. Thereafter, they were discarded.

Statistics:

The LOGIT-Model could not be used as no deaths occurred.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs of toxicity were observed during the study period.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose (LD50) of FAT 45176/A by oral route in rat is greater than 2000 mg/kg body weight.

Executive summary:

An acute oral toxicity study was carried out in Wistar rats according to OECD 401 and EU B.1 guideline. A group of five male and five female HanIbm:WIST (SPF) rats was treated with FAT 45'176/A at 2000 mg/kg body weight 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 body weight. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study. No clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the range of physiological variability known for rats of this strain and age, except one female animal (no. 8) showed a slight loss of body weight during the second observation period. No macroscopic findings were observed at necropsy.

In conclusion, the median lethal dose (LD₅₀) FAT 45176/A by oral route in rat is greater than 2000 mg/kg body weight.