1-Octadecanaminium,N,N-Dimethyl-N-Octadecyl-,(Sp-4-2)-[29h,31h-Phthalocyanine2-Sulfonato(3-)-N 29,N 30,N 31,N 32]Cuprate(1-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study; well documented report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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

Test material

Test material information

Constituent 1

Details on test material:

- Physical state: Powder
- Lot/batch No.: Mix 51785
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 2 animals were 17 weeks old and one animal was 13 weeks old
- Weight at study initiation: 2345-2848 grams
- Housing: individually in cages with perforated floors
- Diet (e.g. ad libitum): Pelleted standard LKK-20 rabbit maintenance diet approximately 100 g per day
- Water (e.g. ad libitum): free access to tap water diluted with decalcified water
- Acclimation period: At least five days under test conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3C
- Humidity (%): 30-70%
- Air changes (per hr): 7.5-15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent/ 12 hours dark


IN-LIFE DATES: From: April 24 1989 To: May 1, 1989

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL

Duration of treatment / exposure:

The test article was instilled in the conjuctival sac of the eye after pulling the lower lid away from the eyeball. The lids were gently held together for about one second to prevent loss of the test article. The eyes of the test animals were not washed out.

Observation period (in vivo):

7 Days

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Draize scores were calculated each day of observation and a Kay and Calandra interpretation was obtained.


TOOL USED TO ASSESS SCORE: 2 % fluorescein in water 24 hours observation period

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 7 Days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible

Remarks:

72 hours

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 11

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 13

Irritation parameter:

maximum mean total score (MMTS)

Time point:

24 h

Score:

7.3

Max. score:

110

Remarks on result:

other: minimally irritating (M1) Kay and Calandra

Other effects:

Lacrimation was observed in all test animals 1 hour after instillation of the substance. The eyelids were stained blue during the first 24 hours, and also demonstrated signs of irritation (redness and swelling) up to 48 hours in two rabbits, and for 72 hours in the third. All effects had resolved by 7 days.

Any other information on results incl. tables

The test article was minimally irritating (M1) to the rabbit eye (Kay and Calandra interpretation of the Draize score 7.3) but did not meet the classification criteria under EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) or by EC No 1272/2008.

Treatment of the eyes with fluorescein 2%, 24 hours after test article instillation revealed no corneal epithelial damage in any of the animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Not classified Criteria used for interpretation of results: EU

Conclusions:

Under the conditons of this study the test material is not classified as an eye irritant under EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) or by EC 1272/2008.

Executive summary:

Under the conditions of this study, the test material resulted in adverse effects on the conjunctivae. The irritation of the conjunctivae was reversible within 72 hours in two animals and with 7 days in the third animal. The test material is not classified as an eye irritant under EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) or by EC 1272/2008.