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

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH Chemisch-Pharmazeutische Fabrik D-88397 Biberach
- Weight at study initiation: 2050 to 2830 g.
- Housing: metal cages
- Diet:: standard 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

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 ml (82 mg) of FAT 40066/C was placed into the conjunctival sac of the left eye of each animal.

Duration of treatment / exposure:

The lids were then held together for about one second in order to prevent loss of the test article.

Observation period (in vivo):

24, 48, and 72 h

Number of animals or in vitro replicates:

3 (one female and two male rabbits)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

6 animal

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Individual eye score:

Animal No.	Time point	Corneal opacity	Iris	Conjunctiva
				Redness	Chemosis
1	After 24 h	0	0	1	0
2		0	0	1	0
3		0	0	1	0
1	After 48 h	0	0	0	0
2		0	0	0	0
3		0	0	0	0
1	After 72 h	0	0	0	0
2		0	0	0	0
3		0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40066 is considered to be a non-irritant to the eyes.

Executive summary:

In a study performed according to OECD guideline 405 to determine the eye irritation potential of FAT 40066/C, the test substance was instilled in the eyes of 1 male and 2 female rabbits and observations for irritation were recorded at the time points of 24 hours, 48 hours 72 hours. 0.1 ml (82 mg) of FAT 40066/C was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The right eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality.

The corneal opacity, iiris and chemosis score was "0" while redness was seen in all animals at 24 h but get reversed within 48 h. There were no mortality or adverse effects were seen in the study.

Under the experimental conditions 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.