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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Dec. 04, 1996 to Jan. 30, 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

German GLP

Test material

Test material information

Constituent 1

Reference substance name:

FAT45'176/A

IUPAC Name:

FAT45'176/A

Test material form:

other: solid

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 (ca. 20°C) away from light.
- Stability under test conditions: stable at storage conditions
- Stability of the test substance in the solvent/vehicle: Stable for at least 48 h in bidistilled water

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH Birkendorferstrasse 65 D - 88397 Biberach / Riss
- Age at study initiation: 15 weeks
- Weight at study initiation: male : 2.5 kg; females: 3.2 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing
- Diet: Pelleted standard Kliba 341 rabbit maintenance diet (batch 71/96) ad libitum from Kliba Mühlen AG, CH-4303 Kaiseraugst
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: Four days under test conditions after health examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-709
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 h artificial fluorescent light/12 h dark

IN-LIFE DATES: December 9-12, 1996

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

electric clipper

Vehicle:

water

Remarks:

bi-distilled water

Controls:

not specified

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 h

Observation period:

72 h.

Viability/Mortality: Daily
Clinical Signs: Daily during the observation period.
Body Weights: At the start of acclimatization, at the start of treatment and at termination of observation.
Irritation Scores: The skin reaction was assessed at approximately 1, 24, 48 and 72 h after the removal of the dressing, gauze patch and test article.

Number of animals:

one male, two females

Details on study design:

The test article was moistened with bi-distilled water before application. Approximately 24 h before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was examined once, 1 day prior to test article administration.
Only those animals with no signs of skin injury or irritation were used in this test.
On the day of treatment, 0.5 g of the test article was applied to approx. 6 cm2 of the intact skin of the clipped area. It was covered with a 2.5 cm x 2.5 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The test article was applied in such a position as to preclude oral ingestion after removal of the dressing.
The duration of treatment was 4 h. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

FAT 45’176/A showed a primary Irritation score of 0.00 when applied to healthy Intact rabbit skin.
Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Other effects:

No clinical signs of systemic toxicity were observed in the animals during the test and observation period and no mortality occurred.
Light orange staining by the test article of the treated skin was observed.
The body weight gain of all rabbits was within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT45'176/A was not irritating to rabbit skin.

Executive summary:

The primary skin irritation potential of FAT 45176/A was investigated in New Zealand White rabbits according to OECD 404 and EU B.4 guideline.

Approximately 24 h before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was examined once, 1 day prior to test article administration. Only those animals with no signs of skin injury or irritation were used in the test. On the day of treatment, 0.5 g of the test article was applied to approx. 6 cm²of the intact skin of the clipped area. It was covered with a 2.5 cm x 2.5 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The test article was applied in such a position as to preclude oral ingestion after removal of the dressing. The duration of treatment was 4 h. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.

The scoring of skin reactions was performed 1, 24, 48 and 72 h after removal of the dressing. The scores of each animal at the following reading times (24, 48,72 hours) were used in calculating the respective mean values for each type of lesion.

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. However, light orange staining by the test article of the treated skin was observed. The body weight gain of all rabbits was within the normal range of variability.

Under the conditions of this experiment, FAT45'176/A was found to cause a primary irritation score of 0.00 (max. 8.0) when applied to healthy intact rabbit skin (Edema and erythema score ‘0’). Therefore, FAT45'176/A was not irritating to rabbit skin.