REAKTIV-ORANGE DYPR 934

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-02-09-1999-02-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in compliance with EEC-Guideline B5 and OECD Guidelines for testing chemicals 405 according to the good laboratory practice regulations annex of paragraph 19a, section 1 of the chemical law of July, 25, 1994.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

-Name of test material (as cited in study report): Reaktiv-Orange DYPR934

Test animals / tissue source

Species:

other: Rabbit, new-zealand white albino

Strain:

other: CrL: KBL (NZW)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
Species: New Zealand albino rabbit
- Origin: Charles River Deutschland GmbH
88353 Kißlegg
- Age at study initiation: 3 healthy young adult rabbits were used
- Weight at study initiation: 3.2 - 4 kg
- Housing: In fully air-conditioned rooms in separate cages arranged in a battery.
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum): Water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C ± 3 °C
- Relative humidity: 50 ± 20 %
- Air changes (per hr): at least 10 X
- Photoperiod (hrs dark / hrs light): 12 hours daily
-Animal identification: numbered ear tags.

Test system

Vehicle:

water

Remarks:

deionized water

Controls:

no

Amount / concentration applied:

100 mg per eye

Duration of treatment / exposure:

24 hours after administration the treated eyes were washed thoroughly with isotonic saline at approx. 37 °C.

Observation period (in vivo):

At 24 and 72 hours as well as after 7 days, the eyes were also examined for corneal lesions under UV light after installation 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. Since effects were still present in the eyes after 72 hours, further examinations were carried out after 7 days

Number of animals or in vitro replicates:

3

Details on study design:

Procedure:
About 24 hours before start the study: the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluorescein-sodium solution.
100 mg Reaktlv-Orsnge DYPR 934 was administered once to the conjunctival sac of the left eye of three rabbits. In each case the untreated eyes served as a control.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
24 hours after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C.
This procedure was repeated at all other designated
SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: fluorescein.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: 57

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: 77

Time point:

other: overall at 24, 48 and 72 h

Score:

1.33

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: 200

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

all animals

Time point:

other: overall at 24, 48 and 72 h

Score:

1.11

Max. score:

3

Reversibility:

fully reversible

Results 5

Irritation parameter:

chemosis score

Remarks:

(Chemosis of conjunctivae)

Basis:

animal: 57

Time point:

other: overall at 24, 48 and 72 h

Score:

0.33

Results 6

Irritation parameter:

chemosis score

Remarks:

(Chemosis of conjunctivae)

Basis:

animal: 77

Time point:

other: overall at 24, 48 and 72 h

Score:

0.33

Results 7

Irritation parameter:

chemosis score

Remarks:

(Chemosis of conjunctivae)

Basis:

animal: 200

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Results 8

Irritation parameter:

chemosis score

Remarks:

(Chemosis of conjunctivae)

Basis:

mean

Remarks:

All animals

Time point:

other: 24-72h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible

Results 9

Irritation parameter:

cornea opacity score

Remarks:

(opacity of cornea)

Basis:

animal: 57

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 10

Irritation parameter:

cornea opacity score

Remarks:

(opacity of cornea)

Basis:

animal: 77

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 11

Irritation parameter:

cornea opacity score

Remarks:

(opacity of cornea)

Basis:

animal: 200

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 12

Irritation parameter:

cornea opacity score

Remarks:

(opacity of cornea)

Basis:

mean

Remarks:

all animals

Time point:

other: 24-72h

Score:

0

Max. score:

4

Results 13

Irritation parameter:

iris score

Basis:

animal: 57

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 14

Irritation parameter:

iris score

Basis:

animal: 77

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 15

Irritation parameter:

iris score

Basis:

animal: 200

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 16

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

2

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 7 days

Other effects:

Bleedings of nictitating membrane were observed in two animals.

Any other information on results incl. tables

Results:

From one hour up to 3 days after; application the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse deeper crimson red color and slight swelling up to partial eversion of lids. The irritations were attended by compound coloured eye discharge. 7 days after application the irritations were reversible.

 The individual findings are given below table.

 Based on the individual scores after 24, 48 and 72 hours, the following mean values were calculated:

 

Opacity of cornea

 all animals : 0.00 Iris                                                

animal 67 : 0.00
animal 77: 0.00
animal 200 ; 0.00

 

Iris:

all animals: 0,00

animal 57 : 0.00
animal 77 : 0.00
animal 200 : 0.00

 

Redness of conjunctiva
all animals : 1.11

animal 57 : 1.00
animal 77 : 1.33
animal 200 : 1.00

 

Chemosis of conjuctiva:

all animals:0.22

animal 57:0.33

animal 77 :0.33

animal 200      :  0.00

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Conclusion:
Testing of Reaktiv-Orange DYPR 934 for primary eye irritation in the rabbit showed that the substance is slightly irritating to eye.

Executive summary:

In an eye irritation study, 100 mg of Reaktiv-Orange DYPR 934 was administered once to the conjunctival sac of the left eye of three rabbits. In each case the untreated eyes served as a control.

The aim of this study was to obtain information on ocular lesions after a single administration of Reaktiv-Orange DYPR 934 to the conjunctival sac of the eye and serves as basis for the classification and labeling.

From one hour up to 3 days after; application the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse deeper crimson red color and slight swelling up to partial eversion of lids. The irritations were attended by compound coloured eye discharge.

Additionally bleedings of nictitating membrane were observed in two animals. 7 days after application the irritations were reversible.

Testing of Reaktiv-Orange DYPR 934 for primary irritation in the rabbit eye showed that the substance would be classified as sligthly irritating to the eye.