Reaction mass of disodium 3-[(5-chloro-2-phenoxyphenyl)azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate and 3-[(5-chloro-2-phenoxyphenyl)azo]-4-hydroxy-5-[[(ptolyl)sulphonyl]amino]naphthalene-2,7-disulphonic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From 10 to 25 of July 1975

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Study following official guideline not in GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous . Substances Labelling Act Sect. 191.12 (February 1965) with slight modification.

GLP compliance:

no

Remarks:

Pre GLP.

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test material form:

solid: particulate/powder

Details on test material:

Acid Red 249
- Appearance: red power
- EC: 229-129-2
- CAS: 6416-66-6
- Alternative name: FAT 21070/B Polar Rot B Roh Trocken
- Purity: 90 %

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Number of animals: 6 (3 male; 3 female)
- Age at study initiation: 9 -14 weeks
- Weight at study initiation: 2.15 (male); 2.57 (female)
- Housing: singly caged
- Diet : commercial irradiated diet (Syles Oxoid), ad libitum
- Water : sterile water, ad libitum for all test duration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ± 2°
- Relative humidity: 50-70 %
- Photoperiod (hrs dark / hrs light): 10 hours of light (8:00-18:00)

Test system

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg of the test compound

Duration of treatment / exposure:

1 second

Observation period (in vivo):

1, 24, 48, 72 h after application and for any further period considered necessary (6 and 10 days)

Number of animals or in vitro replicates:

6 (3 male and 3 female)

Details on study design:

TEST SITE
The eyes of the experimental animals were examined and found normal prior to the test.

REMOVAL OF TEST SUBSTANCE
After 30 seconds the compound was, as far as possible, flushed out of the eye of three of the rabbits with warm water For 1 minute.

SCORE SYSYEM
The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 15, 16

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: 14

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

other: 15, 16

Time point:

24/48/72 h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: 6 days

Results 5

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 14

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 6 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal: 15

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 7

Irritation parameter:

chemosis score

Basis:

animal: 14, 16

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritant / corrosive response data:

CONJUNTIVAL REACTION:
A mild to moderate reaction was seen in all treated eyes one hour after application of the compound.
This had subsided very slightly by 24 hours and thereafter continued to do so until all eyes had returned to normal by day 6 (1/3 unwashed, 3/3 washed) and 10 (2/3 unwashed). Staining of the conjunctivae by the compound was seen in the unwashed eyes at 24 hours.

CORNEAL REACTION:
Slight opacity and damage to the surface epithelium was seen in all treated eyes at one hour. This was still present at 24 hours. These returned to normal by 48 hours (2/3 washed), 72 hours (1/3 washed) and 6 days (3/3 unwashed).

IRIS:
Increased folding of the iris was seen in 2/3 unwashed eyes, (no. 11) at 24 hours and (no. 13) at 40 hours only.

Applicant's summary and conclusion

Interpretation of results:

other: Not clasified according to CLP Regulation (EC) No. 1907/2006.

Conclusions:

Based on the evaluation of the overall score of the eye reaction on Cornea, Iris and Conjunctivae, the substance can be considered slightly irritant under the conditions of the study.

Executive summary:

The determination of the eye irritation was determined in an eye irritation test. No guideline is available and the test was not performed on GLP. The reaction on the test substance was observed in albino rats for 10 days after the instillation. Reactions on Cornea, Conjunctivae and Iris were evaluated.

CONJUNTIVAL REACTION: a mild to moderate reaction was seen in all treated eyes one hour after application of the compound.

This had subsided very slightly by 24 hours and thereafter continued to do so until all eyes had returned to normal by day 6 (1/3 unwashed, 3/3 washed) and 10 (2/3 unwashed). Staining of the conjunctivae by the compound was seen in the unwashed eyes at 24 hours.

CORNEAL REACTION: slight opacity and damage to the surface epithelium was seen in all treated eyes at one hour. This was still present at 24 hours. These returned to normal by 48 hours (2/3 washed), 72 hours (1/3 washed) and 6 days (3/3 unwashed).

IRIS: increased folding of the iris was seen in 2/3 unwashed eyes, (no. 11) at 24 hours and (no. 13) at 40 hours only. Based on the evaluation of the overall score of the eye reactions of Cornea, Iris and Conjunctivae, the substance can be considered slightly irritant under the conditions of the study.