Trisodium 7-(4-(4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazine- 2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 November 1986 to 28 November 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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)

Deviations:

no

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

Reference substance name:

Trisodium 7-(4-(4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazine- 2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate

EC Number:

402-170-5

EC Name:

Trisodium 7-(4-(4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazine- 2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate

Cas Number:

106359-91-5

Molecular formula:

C26H26FN9O13S4.3Na

IUPAC Name:

trisodium 7-{2-[2-(carbamoylamino)-4-{[4-({2-[2-(ethenesulfonyl)ethoxy]ethyl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}phenyl]diazen-1-yl}naphthalene-1,3,6-trisulfonate

Details on test material:

- Name of test material (as cited in study report): FAT 40'224/C
- Description: powder
- Lot/batch No.: Op. 1/86; Vers. 10/86
- Expiration date of the lot/batch: October 1991

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Op. 1/86; Vers. 10/86
- Expiration date of the lot/batch: October, 1991

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under storage conditions: Stable

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: 13 - 14 weeks
- Weight at study initiation: 1.7 - 2.4 kg
- 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: Pelleted standard Kliba 341, Batch 21/86 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) ad libitum.
- Water: 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:

0.1g

Duration of treatment / exposure:

72 h

Observation period (in vivo):

up to 72 h

Number of animals or in vitro replicates:

3 (2 males and 1 female)

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 irritation was assessed and 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

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Irritation: FAT 40224/C showed a primary irritation score of 0.0 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 a red to yellow staining of the cornea, conjunctivae, sclera and lid hairs by pigment or coloring of the test article was observed.
Body weights: The body weight gain of all rabbits was similar.
Necropsy: Due to the results obtained, no macroscopic organ examination was indicated.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40224/C 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. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. In the area of application a red to yellow staining of the cornea, conjunctivae, sclera and lid hairs by pigment or coloring of the test article was observed. The body weight gain of all rabbits was similar. Due to the results obtained, no macroscopic organ examination was indicated. The test substance showed a primary irritation score of 0.0 when applied to the rabbit eye mucosa. A red to yellow staining of the cornea, conjunctivae, sclera and lid hairs of the treated eyes by pigment or coloring of the test article was observed. Cornea, iris, conjunctivae and chemosis scores were 0.0 during the whole observation period. No corrosion 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.