Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[2-[(4-chloro-6-methoxy-1,3,5-triazin-2-yl)amino]ethyl]amino]sulfonyl sulfo derivs., sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations

Version / remarks:

Code of Federal Regulations, Title 16, Section 1500.41.

Deviations:

no

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[2-[(4-chloro-6-methoxy-1,3,5-triazin-2-yl)amino]ethyl]amino]sulfonyl sulfo derivs., sodium salts

EC Number:

275-060-6

EC Name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[2-[(4-chloro-6-methoxy-1,3,5-triazin-2-yl)amino]ethyl]amino]sulfonyl sulfo derivs., sodium salts

Cas Number:

70955-64-5

Molecular formula:

C36.2H18.9Cl0.7CuN11.5O10.2S3.4Na2.7

IUPAC Name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[2-[(4-chloro-6-methoxy-1,3,5-triazin-2-yl)amino]ethyl]amino]sulfonyl sulfo derivs., sodium salts

Test material form:

solid: particulate/powder

Details on test material:

Reactive Blue 71

Test animals

Species:

rabbit

Strain:

not specified

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

water

Remarks:

0.5 Ml water to form a paste

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 g test substance was mixed with 0.5 ml of distilled water to form a paste before application to the skin.

Duration of treatment / exposure:

test patches were removed after 24 hours.

Observation period:

72 hours

Number of animals:

6 animals

Details on study design:

Primary irritation to the skin is measured by a patch test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. A minimum of six subjects are used in abraded and intact skin tests.
Introduce under a square patch such as surgical gauze measuring 1 inch x 1 inch, two single layers thick, 0.5 gram of the test substance.
The animals are immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material such as rubberized cloth for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours exposure, the patches are removed and the resulting reactions are evaluated.
Readings are again made at the end of a total of 72 hours (48 hours after the first reading). An equal number of exposures are made on areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. Evaluate the reactions of the abraded skin at 24 hours and at 72 hours. Add the values for erythema and eschar formation at 24 hours and 72 hours for intact skin to the values on abraded skin at 24 hours and 72 hours (four values). Similarly, add the values for oedema formation at 24 hours and at 72 hours for intact and abraded skin (four values). The total of the eight values is divided by four to give the primary irritation score.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 25/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: 24/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: 24/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: 24/72 h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

other: 24/72 h

Score:

0.5

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: 24/72 h

Score:

0

Max. score:

4

Results 13

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

other: 24/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritant / corrosive response data:

Very slight erythema with and without very slight oedema was observed in the intact and abraded sites of four animals at the 24 hours reading.
Very slight erythema only was observed in the intact and abraded sites of three animals at the 72 hours reading.

Other effects:

The animals did not show any observable response to treatment throughout the 72 hours observation period.

Any other information on results incl. tables

Numerical scores awarded to the dermal reactions elicited by Procion Turquoise H-A

Rabbit no.	Reaction	24 hours		72 Hours
		LEFT Intact	RIGHT Abraded	LEFT Intact	RIGHT Abraded
1	Erythema	1	1	1	1
	Oedema	0	0	0	0
2	Erythema	1	1	1	1
	Oedema	1	1	0	0
3	Erythema	0	0	0	0
	Oedema	0	0	0	0
4	Erythema	0	0	0	0
	Oedema	0	0	0	0
5	Erythema	1	1	0	0
	Oedema	0	0	0	0
6	Erythema	1	1	1	1
	Oedema	0	0	0	0

Primary irritation index = 0.7

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Procion Turquoise H-A is considered to be "mildly irritating" to rabbit skin.
Very slight erythema with and without very slight oedema was observed in the intact and abraded sites of four animals at the 24 hours reading. Very slight erythema only was observed in the intact and abraded sites of three animals at the 72 hours reading. No readings were taken at the 48 hours time point, however, based on the means of the oedema and erythema readings taken at 24 hours and at 72 hours, the substance is not classified under the CLP Regulation.

Executive summary:

The procedure employed was that prescribed by the Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.41.

 

On this occasion 0.5 g of Procion Turquoise H-A was mixed to a paste with 0.5 ml of distilled water before application to the skin.

 

Very slight erythema with and without very slight oedema was observed in the intact and abraded sites of four animals at the 24 hours reading.

 

Very slight erythema only was observed in the intact and abraded sites of three animals at the 72 hours reading.

 

The animals did not show any observable response to treatment throughout the 72 hours observation period.

 

The primary irritation index was calculated to be 0.7

 

CONCLUSION

Procion Turquoise H-A is considered to be "mildly irritating" to rabbit skin.