Tetrasodium 5-[4-chloro-6-(N-ethyl-anilino)-1,3,5-triazin-2-ylamino]-4-hydroxy-3-(1,5-disulfonatonaphthalen-2-ylazo)-naphthalene-2,7-disulfonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 Oct 1990 to 2 Nov 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

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

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FAT 40'406/A
- Lot/batch No.: Vers. Nr. SR 6947/14
- Expiration date of the lot/batch: July 1995
- Stability: Stable
- Storage: At room temperature, protected from light

Specific details on test material used for the study:

Name: FAT 40406/A
Purity: 89.3 %

SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: SR 6947/14
- Expiration date of the lot/batch: July 1995

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the original container, protected from light, at room temperature (approx. 20 °C)
- Stability under test conditions: stable

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf.
- Age at start of treatment: Males: 15 weeks, Female: 16 weeks.
- Weight at start of treatment: Males: 3-3.1 kg, Female: 2.8 kg.
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen).
- Diet: Pelleted standard Kliba 341, batch 56/90 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
- Water: Community tap water from Itingen ad libitum.
- Acclimation period: Four days under test 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):

1, 24, 48, 72 h

Number of animals or in vitro replicates:

3 (2 males, 1 female)

Details on study design:

Both eyes of the animals were observed once, one day prior to test article administration. The test article (0.1 g) 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 h after administration. The irritation was assessed and the corrosive properties of the test article and the staining 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:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

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 3

Irritation parameter:

conjunctivae score

Basis:

mean

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

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Irritation: FAT 40406/A showed a primary irritation score of: 0.42 when applied to the conjunctival sac of the rabbit eye.
Corrosion: No corrosion of the cornea was observed at any of the measuring intervals.

Other effects:

Toxic symptoms/mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.

Coloration: A red staining of the conjunctivae, nictitating membrane, sclera and eyelashes of the treated eyes by pigment or coloring of the test article was observed in all animals from 1 hour until termination of observation. In addition a red staining of the cornea was observed from 24 h to 72 h and a red staining of the iris was observed at different hours according to the animals.

Body weights: The body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40406/A has an irreversible effect on the eye.

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 h. The test substance showed a mean chemosis score of 1 and 0.67 after 1 and 24 h, respectively. The chemosis score was 0.00 at the other time points as were the cornea, iris, and conjunctivae scores during the whole observation period. The primary irritation score was 0.42. No corrosion of the cornea was observed at any of the measuring intervals. A red staining of the conjunctivae, nictitating membrane, sclera and eyelashes of the treated eyes by pigment or coloring of the test article was observed in all animals from 1 h until termination of observation. Therefore, it was concluded that the test substance had irreversible effects in the eye.