A reaction mixture containing the following components;A. Tetralithium [2(or 3), 9 (or 10), 16 (or 17), 23 (or 24)-tetrakis (3-sulfonato-propylsulfonyl) phthalocyaninato]cupurate (II)B. Trilithium [3-(2-hydroxylpropylsulfamoyl)propylsulfonyl]tris (3-sulfonato-propylsulfonyl)phthalocyaninatocupurate (II)C.Dilithium bis [3-(2-hydroxylpropylsulfamoyl)propylsulfonyl] bis (3-sulfonato-propylsulfonyl)phthalocyaninatocupurate (II)D. Lithium tris [3-(2-hydroxylpropylsulfamoyl)propylsulfonyl] (3-sulfonato-propylsulfonyl)phthalocyaninatocupurate (II)E. Tetrakis [3-(2-hydroxpropylsulfamoyl) proppylsulfonyl]phthalocyaninatocupurate (II)In the ratio A:B:C:D:E 6.25 : 25 : 37.5 : 25 : 6.25

Eye irritation

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Administrative data

Endpoint:

eye irritation, other

Remarks:

existing study

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 26th November and 6th January 2003. The final report was issued 7th February 2003.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Meets the criteria for classification as reliable without restriction according to Klimisch et al (1997)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three New Zealand White rabbits were used for the study. At the start of the study the animals were in the weight range of 2.0 to 3.5 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label. The animals were individually housed in suspended metal cages. Free access to mains drinking water and food was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

~ 75 mg

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

Assessment of ocular damage/irritation was made approx. 1h and 24, 48 & 72h following treatment.Additional observations were made on Days 7,14 and 21 to assess reversibility of the occular effects.

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks:

Staining of eye tissue remained at the end of the 21 day observation period.

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks:

Staining of eye tissue remained at the end of the 21 day observation period.

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Max. score:

1

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Max. score:

1

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Max. score:

1

Results 7

Irritation parameter:

other: Conjunctival Discharge

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Max. score:

1

Results 8

Irritation parameter:

other: Conjunctival Discharge

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

1.5

Max. score:

2

Results 9

Irritation parameter:

other: Conjunctival Discharge

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

1.5

Max. score:

2

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 13

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 14

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 15

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Irritant / corrosive response data:

Reversibility of any observed effect: Changes not fully reversible within 21 days

Other effects:

Blue-coloured residual test material was noted around two treated eyes one hour after treatment and one treated eye at the 24 and 48 hour observations. Colouration of the conjunctival membranes was observed in all treated eyes at during the study.Blue-coloured staining of the fur was noted around all eyes during the study.Blue-coloured staining of the conjunctival membranes was noted in all eyes during the study.No corneal or iridial effects were noted during the study.Moderate conjunctival irritation was noted in two treated eyes with minimal conjunctiva! irritation in the remaining treated eye one hour after treatment. Minimal conjunctival irritation was noted in two treated eyes at the 24 and 48-hour observations.No evidence of ocular irritation was noted none treated eye at the 24-hour observation and in the remaining two treated eyes at the 72-hour observation.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The test material produced a maximum group mean score of 8.7 and was classified as a mild irritant (class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. However, the test material caused staining of the conjunctival membranes in all treatee eyes which was present in the eyes of two animals at the end of the 21-day observation period. For this reason the test material is considered to cause irreversible damage to eyes.

Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following: OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002) and Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC.

Results

Blue staining was observed on fur around the eyes, and of the conjunctival membranes during the study. Conjunctival staining was present in the eyes of two animals at the end of the 21-day observation period. Moderate conjuctivial irritation was noted in two treated eyes after 1 hour of treatment. Minimal conjunctivial irritation was noted in two treated eyes at the 72-hour observation time point.

Conclusion

The test material produced a maximum group mean score of 8.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. However, the test material caused staining of the conjunctival membranes in all treatee eyes which was present in the eyes of two animals at the end of the 21-day observation period. For this reason the test material is considered to cause irreversible damage to eyes.