Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-[(4-methyl-3-sulphonatophenyl)sulphonyl]phenyl]azo]naphthalene-2-sulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 April 1994 to 22 June 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:

other: Annex V, part B of Council Directive 79/831/EEC (Commission Directive 92/69/EEC of July 31, 1992)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate

Cas Number:

85187-33-3

Molecular formula:

C26H19BrN4Na2O9S3

IUPAC Name:

Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

Identity - FAT 40066/E TE
Batch - SBL009/LR6G (India)
Appearance - brown powder, solid at 20 °C
Smell - neutral
pH-Value - pH-value of a soln. of 2% (w/w) = 5.2
Expiration date - December 18th, 2018
Storage - to be stored at room-temperature

Specific details on test material used for the study:

- Source and lot/batch number of test material: P.04.36
- Expiration date of the lot/batch: 11/98
- Appearance: Solid
- Storage conditions: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH Chemisch-Pharmazeutische Fabrik D-88397 Biberach
- Weight at study initiation: 2230 to 2330 g
- Housing: metal cages
- Diet: rabbit pellet - Nafag No. 814, Gossau, Switzerland ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.5 g of the test article

Duration of treatment / exposure:

4 h

Observation period:

The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system

Number of animals:

3 male rabbits

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

The skin reactions observed were reversible until the end of the observation period.

Individual skin reaction scores:

	Mean Reaction Score
Time after exposure hours	Erythema			Edema
	Animal 1	Animal 2	Animal 3	Animal 1	Animal 2	Animal 3
24	1	0	1	0	0	0
48	1	0	0	0	0	0
72	0	0	0	0	0	0

 

Because the mean values of the recordings 24 t o 72 hours after application are below the threshold of significance (2 score for erythema or edema) FAT 40066/C can be classified as non-irritant according to council Directive 67/548/EEC, adapted to technical progress by Commission Directive 93/21/EEC.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40066/C is to be considered as a non-irritant to the skin of rabbits.

Executive summary:

A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 40066/C, on the skin of the New Zealand White rabbits. The study was carried out according to OECD guideline 404. 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 was applied to the contralateral flank. Before application both patches were moistened with distilled water. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape.

One animal from treatment group showed erythema till 48 h and one another animal till 24h observation perion. There were no edema observed.

Because the mean values of the recordings 24 t o 72 hours after application are below the threshold of significance FAT 40066/C can be clasified as non-irritant to the skin of rabbits.