A mixture of: sodium/potassium 7-[[[3-[[4-((2-hydroxy-naphthyl)azo)phenyl]azo]phenyl]sulfonyl]amino]-naphthalene-1,3-disulfonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 August 1992 to 20 November 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

code number: FAT 45155/B
batch No.: HT 3728/ TV 1
physical appearance: powder, dark red
purity: 60-70 %
Storage conditions: room temperature, keep dark
Validity: May 15, 1997
storage: room temperature, keep dark
expiration date: May. 15, 1997
safety precautions: gloves and face masks

Specific details on test material used for the study:

Test article: FAT 45155/B
Trade name: ERIONYL ROT HT 3728
Batch No.: HT 3728/TV 1
Purity: 60 - 70 %
Physical properties: powder; dark red
Storage conditions: room temperature; keep dark
Validity: May 15, 1997

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The rabbits were recognized by the international guideline as the recommended test system. Total number of animals are one female and two males.
TEST ANIMALS
- breeder: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- acclimatisation period: at lease 5 days
- Weight at study initiation: 2500-2730 g
- Housing: individually in metal cages
- Feed: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: fresh water ad libitum

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

Test system

Vehicle:

water

Controls:

other: The right eye remained untreated and was used as the control.

Amount / concentration applied:

The application volume was 0.1 ml (91 mg) per animal.

Duration of treatment / exposure:

0.1 ml (91 mg) of FAT 45155/B 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.

Observation period (in vivo):

viability/mortality: Daily;
ocular reaction: ocular reactions were evaluated 1, 24, 48 and 72 hours after the instillation of test substance
body weight: at start and on days 3 and 7

Number of animals or in vitro replicates:

one female and two males

Details on study design:

The ocular reactions were evaluation 1, 24, 48 and 72 hours after the instillation of test substance according to the OECD scoring system. A slit-lamp was used to facilitate the evaluation. The irritation/corrosive potency of test substance was classified.

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

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

1.11

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

No irritation or corrosion was observed.

Other effects:

The eye reactions observed were reversible until the end of the observation period on day 7.

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	1
3		0	0	2	1
1	After 48 h	0	0	1	0
2		0	0	1	0
3		0	0	1	0
1	After 72 h	0	0	1	0
2		0	0	1	0
3		0	0	1	0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 45155/B is considered as non-irritant to rabbit eye.

Executive summary:

A GLP-compliant study was performed to access the primary eye irritation potential of FAT 45155/B. Two males and one female were exposed a single dose of test substance (0.1 ml or 91 mg per animal) placed in the eyes of rabbits. The reaction was assessed at 1, 24, 48 and 72 h intervals after administration. Under the experimental conditions employed the test substance induced reactions of the iris and conjunctiva when instilled into the conjunction sac of albino rabbits' eyes. The mean values of the readings 24 to 72 h after instillation for Cornea and Iris was ‘0’ while for redness and chemosis was 1.11 and 0.22, respectively, which are below the threshold of significance. The eye reactions observed were reversible until the end of the observation period on day 7. Based on the study result of this test, FAT 45155/B is considered as non-irritant to rabbit eye.