Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliance with internation guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

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

Reference substance name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.

EC Number:

277-257-2

EC Name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.

Cas Number:

73049-92-0

Molecular formula:

not applicable

IUPAC Name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Reactive Blue 21

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: about 3-5 months
- Weight at study initiation: 2.4-2.7 Kg
- Housing: In fully air-conditioned rooms in separate cages arranged in a battery
- Diet: Altromin 2123 (Altromin GmbH, Lage/Lippe) ad libitum and hay (approx. 15 g daily)
- Water: water from automatic water dispenser ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: 50±20 %
- Photoperiod: 12 hours cycle dark/light

From: 6. to 9. September 1988

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

The eyes were examined 1, 24, 48, 72 hours after application of the test substance.

Number of animals or in vitro replicates:

3

Details on study design:

PREPARATION
About 24 hours before the start of the study the test eyes of all animal were examined under UV light for corneal lesion after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animal without ocular abnormalities were used for the study.

REMOVAL OF TEST SUBSTANCE
- Washing: yes with isotonic saline at 37°C
- Time after start of exposure: 24 hours

TOOL USED TO ASSESS SCORE: fluorescein; at 24 and 72 hours the eyes were also examined for corneal lesion under UV light after instillation of one drop of 0.01% fluorescein-sodium solution.

SCORING SYSTEM: according to OECD guideline 405

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72 hours

Score:

0.1

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 hours

Score:

0.1

Max. score:

3

Reversibility:

fully reversible

Irritant / corrosive response data:

One hour up to 2 days after application the conjunctivae of the animal showed an evident hyperemia of the blood vessels and a slight to obvious swelling. Additionally a clear, blue colored discharge was observed. 2 days after application the signs of irritation were reversed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Testing of Reactive Blue 21 for primary eye irritation in the rabbit showed, that the substance is not irritating to eyes.

Executive summary:

About 24 hours before the start of 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 % f1uorescein-sodium solution. Only animals without ocular abnormalities were used for

the study.

100 mg Reactive Blue 21 was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.

24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C.

The eyes were examined 1, 24, 48 and 72 hours after application of the test substance.

At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded.