Reaction products of diazotised sodium 2-amino-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate coupled with sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate, subsequently coupled with diazotised sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Remarks:

Read across data

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

data is from experimental reports of read across subtance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the eye irritation potential of the test chemical in rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

EC Number:

228-783-6

EC Name:

Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

Cas Number:

6358-69-6

Molecular formula:

C16H10O10S3.3Na

IUPAC Name:

trisodium 8-hydroxypyrene-1,3,6-trisulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material: D & C Green no. 8
- Molecular formula: C16H10O10S3.3Na
- Molecular weight: 524.389 g/mol
- Physical state: Solid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill, Ltd., UK)
- Age at study initiation: no data available
- Weight at study initiation: no data available
- Housing:The animals were conventionally kept in single cages
- Diet (e.g. ad libitum): appropriate diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

About 100 mg of the finely powdered test specimen and 100 microliters of a 30% or 3% strength aqueous solution of the test chemical

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

The findings were obtained 1, 24, HS and 72 hours after administration and at the end of the follow-up period of 7 days

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: no

SCORING SYSTEM: The condition of cornea, iris and conjunctivae according to DRAIZE was assessed. The condition of cornea, iris and conjunctivae according to DRAIZE was assessed (see rating table). All other findings not covered by the DRAIZE scale were also recorded. For evaluation, the DRAIZE grades were used at approximately 24, 48, and 72 hours after application.

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein : no data available

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Following application of the neat test material, all animals showed slight conjunctival redness which in five of 6 animals was completely reversible within 72 hours, and in one animal within 7 days.
In two animals, very slight tear flow occurred after application which also was completely reversible within 48 hours.
Following application of a 30% aqueous solution of the test material, all animals showed slight conjunctival redness (max. score 1) one hour after application which was completely reversible within 24 hours.
Following application of a 3% aqueous solution, three animals showed slight conjunctival redness (max. score 1) at 24 hours after application which was completely reversible within 48 hours.

Any other information on results incl. tables

Table #: Irritant/corrosive response data for neat substance  for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0/0/0/0	0/0/0/0/0/0	1/1/2/1/1/1	0/2/1/0/1/0
24 h	0/0/0/0/0/0	0/0/0/0/0/0	1/2/1/1/0/2	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0	1/1/1/1/0/1	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0	0/1/0/0/0/0	0/0/0/0/0/0
7 d	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0/0/0/0/0/0	0/0/0/0/0/0	0.6/1.3/0.6/0.6/0.0/1.0	0/0/0/0/0/0
Area effected	0/0/0/0/0/0
Reversibility*)			c.	c.
Average time (unit) for reversion			7 d	24 h

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Judgment is based on mean scores for each animal following grading at 24, 48 and 72 hours after application of the test material, in consideration of reversibility.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The eye potential of the test chemical was evaluated in rabbits. Following application of the neat test material, all animals showed slight conjunctival redness which in five of 6 animals was completely reversible within 72 hours, and in one animal within 7 days. In two animals, very slight tear flow occurred after application which also was completely reversible within 48 hours.
Following application of a 30% aqueous solution of the test material, all animals showed slight conjunctival redness (max. score 1) one hour after application which was completely reversible within 24 hours. Following application of a 3% aqueous solution, three animals showed slight conjunctival redness (max. score 1) at 24 hours after application which was completely reversible within 48 hours. Since the observed effects were reversible by 7 days, the test chemical can be considered to be not irritating to rabbit eyes.

Executive summary:

The eye potential of the read across substance Trisodium 8-hydroxy-1,3,6-pyrenetrisulfonate (CAS no.: 6358-69-6) was evaluated in rabbits. 6 albino rabbits were used for the study. The animals were conventionally kept in single cages and were given an appropriate diet and tap water ad libitum. For each of the 6 rabbits, about 100 mg of the finely powdered test specimen and 100 microliters of a 30% or 3% strength aqueous test chemical solution were applied to the conjunctival sac of one eye. Only animals with intact eyes were used.The untreated eye served as control. The findings were obtained 1, 24, 48 and 72 hours after administration and at the end of the follow-up period of 7 days. The condition of cornea, iris and conjunctivae according to DRAIZE was assessed. Following application of the neat test material, all animals showed slight conjunctival redness which in five of 6 animals was completely reversible within 72 hours, and in one animal within 7 days. In two animals, very slight tear flow occurred after application which also was completely reversible within 48 hours. Following application of a 30% aqueous solution of the test material, all animals showed slight conjunctival redness (max. score 1) one hour after application which was completely reversible within 24 hours.  Following application of a 3% aqueous solution, three animals showed slight conjunctival redness (max. score 1) at 24 hours after application which was completely reversible within 48 hours. Since the observed effects were reversible by 7 days, the test chemical can be considered to be not irritating to rabbit eyes.