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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov. 26, 1996 - Jan. 10, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

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
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. Wolferstrasse 4, 4414 Füllinsdorf / Switzerland
- Females (if applicable) nulliparous and non-pregnant: Not Specified
- Age at study initiation: males: 8 weeks; females: 11 weeks
- Weight at study initiation: males: 233.5 to 258.7 g; females: 201.8 to 224.9 g
- Housing: individually in Makrolon type-3 cages with standard softwood bedding
- Diet: Pelleted standard Kliba 343, Batch no. 81/96 rat maintenance diet (Kliba Mühlen AG, CH-4303 Kaiseraugst) available ad libitum
- Water: Community tap water from Itingen, available 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 fluo- rescent light/12-h dark

IN-LIFE DATES: From: 03-DEC-1996 to 17-DEC-1996

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

bi-distilled water

Details on dermal exposure:

One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10 % of the total body surface. Only those animals without injury or irritation on the skin were used in the test.
On test day 1, the test item was applied at a dose of 2000 mg/kg body weight evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
Application volume/kg body weight: 4 mL/kg
Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels.

Duration of exposure:

24 h

Doses:

2000 mg/kg body weight (4 mL/kg)

No. of animals per sex per dose:

5

Control animals:

no

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 occured during the study.

Clinical signs:

other: No systemic signs of toxicity were observed.

Gross pathology:

No macroscopic findings were observed at necropsy.

Other findings:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal median lethal dose (LD50) of FAT 45176/A in rats was above 2000 mg/kg body weight.

Executive summary:

The acute dermal toxicity study was carried out on Wistar rats according to OECD 402 and EU B.3 guideline. The test item was applied to a group of 5 male and 5 female rats by dermal application, at the single dose of 2000 mg/kg body weight.

No death occurred during the study period. No clinical signs of systemic toxicity were observed during the observation period except

scales were noted in eight animals at different durations between test day 3 and 15. Orange discoloration of the skin at the application site was evident in all animals after the removal of the dressing on test day 2 and persisted until study termination.

There were no test item-related effects on body weight of the male and females animals during the observation period. No organ abnormalities were observed at necropsy.

Based on the study results, the median lethal dose (LD₅₀) of FAT 45176/A was estimated to be greater than 2000 mg/kg.bw.