Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

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)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

EC Number:

271-351-7

EC Name:

Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Cas Number:

68541-71-9

Molecular formula:

C32H17CrN6O11S.2Na

IUPAC Name:

disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Test material form:

other: solid

Details on test material:

None

Specific details on test material used for the study:

Test article: FAT 20011/D
Additional specification: Lanacron Marine S-G roh feucht
Batch No.: 61
Purity/Contents: CA. 52.5 %
Physical properties: solid
Storage conditions: room temperature
Validity: July 1999
Safety precautions: gloves and face masks
Test material received: March 22, 1994

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The test was performed on 3 male rabbits, checked for normal skin conditions, weighing between 2190 to 2310 g. The animals were housed individually in metal cages, identified by ear tattoo, kept at a constant room temperature of 20+/-3 °C, at a relative humidity of 30-70 % and on a 12 hours light cycle day.

TEST ANIMALS
- Source: Chemisch-pharmazeutische Fabrik D-88397 Biberach
- Weight at study initiation: between 2190 to 2310 g
- Housing: The animals were housed individually in metal cages, identified by ear tattoo.
- Diet: The rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water.
- Water:ad libitum
- Acclimatisation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod: 12 hours light cycle day

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: A control gauze patch moistened with distilled water was applied to the contralateral flank.

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

3 days

Number of animals:

3 males

Details on study design:

TEST SITE
An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test article was applied to the right flank of each animal. The skin area exposed directly to the test article was approx. 6 cm². A control gauze patch moistened with distilled water was applied to the contralateral flank. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).
The animals were checked daily for systemic symptoms and mortality (only findings reported).
The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.

SCORING SYSTEM:
SCORE FOR SKIN IRRITATION IN RABBITS:
Erythema and eschar formation
- No erythema:........................................................................................................... 0
- Very slight erythema (barely perceptible):................................................................... 1
- Well defined erythema:............................................................................................. 2
- Moderate to severe erythema:................................................................................... 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth):................ 4
Total possible erythema score 4

Edema formation
- No edema:..................................................................................................................... 0
- Very slight edema (barely perceptible):............................................................................. 1
- Slight edema (edges of area well defined by definite raising):............................................... 2
- Moderate edema (raised more than 1 mm):........................................................................ 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure:................... 4
Total possible edema score 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

The body weight growth was not affected by the exposure.

Any other information on results incl. tables

Overall results:

3 animals or less	Mean score animal 1*	Mean score animal 2*	Mean score animal 3*	Max value	Maximum duration of any effect	Max value at the end of the observation period
Erythema/eschar	0.33	0.33	0.33	1	24 hours	0
Edema	0	0	0	1	1 hour	0

* Calculated on the basis of the scores at 24, 48 and 72 hours for each animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20011/D is not irritating to the rabbit skin.

Executive summary:

The aim of this study was to determine the potential of FAT 20011/D to cause irritation on skin. The study was carried out according to OECD Guideline 404 and EU Method B.4. An area of at least 36 cm² was shaved on both flanks of the three New Zealand rabbits. A gauze patch bearing 0.5 g of the test article was applied to the right flank of each animal. The skin area exposed directly to the test article was approx. 6 cm². A control gauze patch moistened with distilled water was applied to the contralateral flank. The patches were loosely covered with an aluminum foil and held in place for 4 hours by an adhesive tape. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. The mean score for erythema after 24/48/72 hrs was found to be 0.33 and the mean edema score was found to be 0. The skin reactions observed were reversible by 48 h observation. As the mean values of the recordings 24 to 72 hours after application were below the threshold of significance (2 score for erythema or edema) FAT 20011/D can be classified as non-irritant.