Pentasodium 7-(4-(4-(5-amino-4-sulfonato-2-(4-((2-(sulfonato-ethoxy)sulfonyl)phenylazo)phenylamino)-6-chloro-1,3,5-triazin-2-yl)amino-2-ureidophenylazo)naphtalene-1,3,6-trisulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 October 1995 to 22 December 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

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 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

FAT 40549

IUPAC Name:

FAT 40549

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

-Identification: CIBACRON GELB TZ 4210 ROH LÖSUNG (LABORGETROCKNET)(FAT 40'544/A)
- Description Red powder
- Vers. No.: TV 1
- Purity/Formulation: Ca. 90%
- Stability of Test Article: Stable under storage condition; expiration date: NOV-2000
- Stability of Test Article in Vehicle: Unknown in bi-distilled water, therefore is excluded from the statement of compliance.
- Storage Conditions: In the original container at room temperature away from direct sunlight.
- Safety Precautions : Routine hygiene procedures were used to ensure the health and safety of the personnel.

Specific details on test material used for the study:

Identification: CIBACRON GELB TZ 4210 ROH LÖSUNG (LABORGETROCKNET) (FAT 40'544/A)
Description: Red powder
Vers. No: TVi
Purity/Formulation: ca 90%
Stability of Test Article: Stable under storage condition; expiration date: NOV-2000
Storage Conditions: In the original container at room temperature away from direct sunlight.
Safety Precautions: Routine hygiene procedures were used to ensure the health and safety of the personnel.

Test animals

Species:

rat

Strain:

other: Hanlbm: WIST (SPF)

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.
- Age at study initiation: males: 8 weeks; females: 10 weeks
- Weight at study initiation: males: 208.0 - 215.8 g; females: 180.1 - 192.4 g
- Fasting period before study: approximately 16 hours
- Housing: Groups of five in Makrol on type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: One week under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 °C
- Humidity (%): 37 - 72 %
- Air changes (per hr): Air-conditioned with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark (light period between 6.00 a.m. to 6.00 pm.), music during the light period.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Bi-distilled

Details on oral exposure:

VEHICLE
- Amount of vehicle: 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg.

DOSAGE PREPARATION: The test article was placed into a glass beaker on a tared Mettler PM 480 balance, and the vehicle (bi-distilled water) was added. A weight by volume dilution was prepared using a homogenizer.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 females and 5 males per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Four times during test day 1 and daily during days 2 - 15 for mortality and viability observation. On test day 1 (pre-administration), 8 and 15 for weight observation.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights and histopathology.

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortaility observed

Clinical signs:

other: No clinical signs of toxicity observed

Gross pathology:

No organ abnormalities were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50(rat, oral) was found to be greater than 2000mg/kg.

Executive summary:

The test substance was administered to a group of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg test article/kg body weight.

The test was perfermed according to OECD test guideline 401 in a GLP certified laboratory.

The animals were observed four times during test day 1 and daily during days 2 - 15 for mortality and viability observation.

There were no deaths as a result of treatment with the test article. No clinical signs of toxicity were observed during the observation period and the body weight of the animals was within the normal range for rats of this strain and age. No organ abnormalities were observed at necropsy.

Thus, LD50 oral was greater than 2000 mg//kg bw based on the test results.