Reaction mass of 1,5-Naphthalenedisulfonic acid, 3,3'-[(4-methyl-1,2-phenylene)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino[2-(acetylamino)-5-methoxy-4,1-phenylene]-2,1-diazenediyl]]bis-, sodium salt (1:4) and 1,5-Naphthalenedisulfonic acid, 3,3'-[(3-methyl-1,2-phenylene)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino[2-(acetylamino)-5-methoxy-4,1-phenylene]-2,1-diazenediyl]]bis-, sodium salt (1:4)

Eye irritation

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Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From October 1988 to November 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Mellor rabbits.
- Weight at study initiation:
- Housing: 3613 to 4118 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 ± 20˚C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 20-30 per h
- Photoperiod (hrs dark / hrs light): 12 h light and 12 darkness

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

unwashed (entire study)

Observation period (in vivo):

21 d

Number of animals or in vitro replicates:

3

Details on study design:

Both eyes of each rabbit were examined within the 24 h prior to the study. The examination consisted of a visual assessment with the aid of fluresceine and only rabbits without any appearance eye defects or ocular irritation were used. 3 male rabbits were used for this study. Each animals was given a number, unique within the study, which was written both on the inner side of one ear, using a black waterproof marker pen, and on the cage card. The bodyweight of each animal, at the start of the study, was recorded.

Initially the test sample (approximately 100 mg) was applied into the conjunctival sac of the left eye of one rabbit gently pulling the lower lid way from the eyeball to form a cup into which the test sample was dropped. The lids were then gently held together for 1-2 seconds, after which the animal was released. The other eye was untreated. Immediately after application of the test substance, an assessment of the initial pain reaction of the rabbit was made using a six point scale. After 24 h the test substance was applied into the eye of the remaining two animals as described previously and an assessment of initial pain reaction was made.
The eye were examined and the draize scale was used to assess the grade of ocular reaction approximately 1 h and 1,2,3 and 4 d after application of the test substance for all animals and 7, 15, 20 and 21 d after application in two of the animals.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.2

Max. score:

3

Reversibility:

fully reversible within: 4 d

Remarks on result:

probability of mild irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Slight to moderate conjunctivae redness fully disappeared within 4 d. The substance did not cause any severy irritation/corrosion.

Any other information on results incl. tables

Installation of the test substance into rabbit eye caused slight initial pain in all three animals. No corneal opacity or iritis were seen in any of the animals. Slight redness and slight or moderate discharge were seen in all three animals and persisted for up to 3 d after application of the test substance. Very slight chemosis was also seen in all animals for another 2 d. 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the substance was not significantly irritating in rabbit eyes.