Trisodium 7-[[4-chloro-6-[ethyl[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

From July 12, 1982 to July 26, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

in unwashed eyes the duration of te observation period is insufficient; in washed eyes, the study is acceptable

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Nine New-Zealand white rabbits received 100 mg of the test substance in the conjunctival sac of one eye. The other eye served as negative control. The treated eyes of 6 animals remained unwashed and eyes of the other 3 animals were washed after application. Signs of ocular irritation were examined at 1, 24, 48, 72 and 96 h and at 1 and 2 weeks after treatment. The grading and scoring of irritating reactions was performed in accordance with the Draize scale.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 7-[[4-chloro-6-[ethyl[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate

EC Number:

280-489-7

EC Name:

Trisodium 7-[[4-chloro-6-[ethyl[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate

Cas Number:

83567-04-8

Molecular formula:

C30H28ClN7O14S4.3Na C30H25ClN7Na3O14S4

IUPAC Name:

trisodium 7-[[4-chloro-6-[ethyl[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Origin: Nihon Dobutsu Co., Osaka
Body weight: 2.28 - 3.17 kg
Temperature and relative humidity: 24+/-2°C and 60+/-10%, respectively
Lighting time: 12 h daily
Food: CG-3 type (100 g/day)
Water: tap water, ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg on the everted lower lid

Duration of treatment / exposure:

Unwashed group: NA
Washed group: 30 seconds

Observation period (in vivo):

14 d

Number of animals or in vitro replicates:

Unwashed group: 6
Washed group: 3

Details on study design:

Nine New-Zealand white rabbits received 100 mg of the test substance in the conjunctival sac of one eye. The other eye remained untreated and served as negative control. The treated eyes of 6 animals remained unwashed and eyes of the other 3 animals were washed after application. Reading of ocular lesions was conducted at 1, 24, 48, 72 and 96 h and at 1 and 2 weeks after treatment. The grading and scoring of irritating reactions was performed in accordance with the Draize scale.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 animals for 1 minute with 300 mL lukewarm water
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

washed

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Remarks:

unwashed

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0.83

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Results 3

Irritation parameter:

iris score

Remarks:

washed

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

iris score

Remarks:

unwashed

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Remarks:

washed

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

conjunctivae score

Remarks:

unwashed

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

chemosis score

Remarks:

washed

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

chemosis score

Remarks:

unwashed

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test substance produced some grade of irritant reactions such as cornea opacity and hyperemia, chemosis and discharge in conjunctiva in unwashed eyes at 1 or 24 h after application. In the washed eyes, no irritant reaction was observed in the animals. The mean total score of these irritant reactions for the unwashed group was maximum at 24 h after application and the score was 11.2. Although slight cornea opacity remained in 4/6 unwashed animals after 14 d, other irritant reactions disappeared within 2 to 7 d after application in all remaining animals.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the study conditions, the substance was considered not to be irritating to eyes if the substances is washed out of the eyes. If the substance is not washed out, slight cornea opacity remained for 14 days in 4 of 6 rabbits showing a tendency for reversibility in the areas affected.

Executive summary:

A study was conducted to determine the eye irritation potential of the substance according to an internal method of the laboratory. Nine New-Zealand white rabbits received 100 mg of the test substance in the conjunctival sac of one eye. The other eye remained untreated and served as negative control. The treated eyes of 6 animals remained unwashed and eyes of the other 3 animals were washed after application. Signs of ocular irritation were examined at 1, 24, 48, 72 and 96 h and at 1 and 2 weeks after treatment. The grading and scoring of irritating reactions was performed in accordance with the Draize scale. The test substance produced irritant reactions such as corneal opacity and hyperemia, chemosis and discharge in the conjunctiva of unwashed eyes at 1 and 24 h after application. In the washed eyes, no irritant reaction was observed in the animals. The mean total score of these irritant reactions for the unwashed group was 11.2 at 24 h. Slight corneal opacity remained in 4 out of 6 unwashed animals at 14 d, other irritant reactions disappeared within 2 to 7 d after application in all remaining animals. (Hosokawa, 1982).