3-Pyridinemethanesulfonic acid, 5-[2-[5-[[4-chloro-6-[(4-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]diazenyl]-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-, potassium sodium salt (1:?:?)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): FAT 40 279/B
- Batch number: UO-Vers. 1276/86
- Stability: stable
- Expiration: December 1991

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414, Fuellinsdorf, Switzerland
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 2.8-2.9kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen / FRG)
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, batch 23/87 rabbit maintenance diet ("Kliba", klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) ad libitum
- Water (e.g. ad libitum): Community tap water from Itingen ad libitum
- Acclimation period: Four days under laboratory conditions after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

up to 72 hours

Number of animals or in vitro replicates:

3; 1 male, 2 females

Details on study design:

The eyes of the animals were observed 24 hours prior to test article administration. The test article (0.1 g per animal) was placed in the conjunctival
sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control. The eyes of each animal were examined 1, 24, 48 and 72 hours after administration. The corrosive properties of the test article and the color of the treated eye were described and recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hours

Score:

1

Max. score:

3

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

0.67

Max. score:

3

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48 and 72 hours

Score:

0

Max. score:

3

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 7

Irritation parameter:

other: Primary irritation score

Basis:

mean

Time point:

other: average 1, 24, 48, 72 hours

Score:

0.4

Max. score:

13

Irritant / corrosive response data:

Irritation: FAT 40 279/B showed a primary irritation score of 0.4, when applied to the rabbit eye mucosa.
Corrosion: No corrosion of the cornea was observed at any of the measuring intervals.

Other effects:

Toxic symptoms/mortality: No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
Coloration: In the area of application yellow staining of the sclera, nictating membrane and lid hair by pigment or coloring of the test article was observed.
The body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.

Executive summary:

In a GLP compliant eye irritation study, performed according to OECD guideline 405, the test substance (0.1 g) was placed in the conjunctival sac of the left eye of three New Zealand White rabbits. The eyes were examined for 72 hours. The test substance showed a mean chemosis and conjunctivae score of 1 and 0.67 at 1 and 24 hours, respectively, but 0.00 at the other time points (48 and 72 hours). Cornea and iris scores were 0.00 during the whole observation period. The primary irritation score was 0.4. No corrosion of the cornea was observed at any of the measuring intervals. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.