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

Skin irritation / corrosion

Some information in this page has been claimed confidential.

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo; existing study

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 20 November 2002 and 23 November 2002. 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.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three New Zealand White rabbits were used in 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 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.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: Distilled Water

Controls:

no

Amount / concentration applied:

500 mg moistiened with 0.5ml of distilled water.

Duration of treatment / exposure:

4 h

Observation period:

1 hour after the removal of the patches and 24, 48 and 72 hours later.The test sites were examined for evidence of primary irritation and scored accordingly.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 4

Irritation parameter:

erythema score

Max. score:

0

Remarks on result:

other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 8

Irritation parameter:

edema score

Max. score:

0

Remarks on result:

other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)

Any other information on results incl. tables

Skin reaction	Observation Time	79 male	80 male	81 male	Total
ErythemaIEschar Formation	l Hour 24 Hours 48 Hours 72 Hours	0  0 0 0	0 0 0 0	0 0 0 0	0 0 0 0
Oedema Formation	l Hour 24 Hours 48 Hours 72 Hours	0  0 0 0	0  0 0 0	0  0 0 0	0  0 0 0
sum of 24 and 72 -hour readings (S)	0
Promary irritation Index (S/6)	0/6=0

Classificatiom                                                 NON-IRRITANT

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following: 1) OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 24 April 2002) 2) Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC

Results and conclusion

No evidence of skin irritation was noted during the study. The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.