REAKTIVE GELB F 97494

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From October 23, 2001 to November 06, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

443-090-0

EC Name:

-

Cas Number:

477795-15-6

Molecular formula:

C26H24FN8Na3O14S4

IUPAC Name:

Trisodium 2-{2-[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3-yl]diazen-1-yl}-4-{[4-fluoro-6-({4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}benzene-1-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Reaktivgelb F-97494

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

Crl:KBL(NZW)BR (N.Zeal.White)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Body weight at start of study: 2.4–3.1 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery (room number 051).
- Diet: ssniff K-H (V2333), ad libitum and hay (approximately 15 g daily)
- Water: from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
- Animal identification: Ear tags and cage numbering

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (except short lasting deviations due to disturbances of air condition)
- Humidity: 50±20 % (except short lasting deviations due to disturbances of air condition)
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: To: October 23, 2001 to November 06, 2001

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 24, 48 , 72 h and and after 7 d following administration of the test substance.

Number of animals or in vitro replicates:

3 females

Details on study design:

ROUTE OF ADMINISTRATION: conjunctival

FREQUENCY OF ADMINISTRATIONS: single dose

PREPARATION OF THE TEST SUBSTANCE:
Each animal was treated with 100 mg of test substance


TEST PROCEDURE

About 24 h before the start of the study both eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.

0.1 mg of test substance was administered once to the conjunctival sac of the left eye of three rabbits. In each case the untreated eye served as a control. 24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approximately 37°C. The eyes were also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.

The eyes were examined 1, 24, 48 and 72 h after administration of the test substance. At 24 and 72 h and after 7 d, the eyes were further examined for corneal lesions under UV light after instillation of one drop of a 0.01% fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded when apparent. Since effects were still present in the eyes after 72 h, further examinations were carried out after 7 d.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 5

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 6

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

1 h up to 72 h after administration the conjunctivae of the animals showed definitely injected blood vessels up to crimson colour. 1 h up to 24 h after administration the conjunctivae of the animals showed slight up to obvious swelling. Furthermore, two animals showed bleedings of the nictitating membrane from 24 h up to 72 h after administration. In addition to these observations, serous eye discharge discolored by the substance was noted. 7 d after administration all signs of irritation had disappeared.

Other effects:

No clinical signs of systemic toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test substance was considered to be not irritating to eyes.

Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance in Crl:KBL(NZW)BR female rabbits according to OECD Guideline 405, EPA OPPTS 870.2400 and EU Method B.5, in compliance with GLP.

 

A single dose of 100 mg test substance was applied to the conjunctival sac of the left eye of each animal. The treated eyes were washed out 24 h after the administration of the test substance. The untreated eyes served in each case as a control.

 

Except for conjunctivae redness and chemosis which were fully reversible within 7 d, no severe irritating effects were observed. Further, no clinical signs of systemic toxicity were seen.

 

Under the test conditions, the test substance was considered to be not irritating to eyes.