Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., ammonium sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 'Appraisal of the safety of chemicals in Food, Drugs and Cosmetics' 1959 of the US Association of Food and Drug officials.

Principles of method if other than guideline:

Patch-test technique

GLP compliance:

no

Remarks:

pre GLP

Test material

Test material information

Constituent 1

Reference substance name:

Direct Blue 199_Na

IUPAC Name:

Direct Blue 199_Na

Test animals

Species:

rabbit

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Russian breed
- Weight at study initiation: 1.5 to 2 kg
- Housing: individual housing in metal cages, 47 × 32 × 34 cm.
- Diet: ad libitum, standard - Nafag.
- Water: ad libitum.
- Acclimation period: 8 days minimum.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 14 hours light/day

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml

Duration of treatment / exposure:

The gauze patches were removed 24 hours after application.

Observation period:

8 days

Number of animals:

6 rabbits: 3 males, 3 females

Details on study design:

TEST SITE
- Area of exposure: rabbits were shaved one day before treatment with an electric clipper on the flanks. The shaved skin area on the left side was slightly scarified just before treatment.
- Type of wrap if used: a gauze patch 2.5 x 2.5 cm was laden with the test substance and immediately applied to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape.

SCORING SYSTEM
The reaction of the skin was appraised upon removal during an observation period of 8 days on the basis of the following evaluation scheme.

Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth): 4
Total possible erythema score: 4

Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible erythema score: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 6/6

Time point:

other: mean 24, 48 and 72 h

Score:

< 2.3

Remarks on result:

other: both intact and abraded skin

Results 2

Irritation parameter:

edema score

Basis:

animal: 6/6

Time point:

other: mean 24, 48 and 72 h

Score:

< 2.3

Remarks on result:

other: both intact and abraded skin

Irritant / corrosive response data:

Under the test conditions, the test item was found to be non irritant w'hen applied to intact or abraded rabbit skin.

Any other information on results incl. tables

	24 hrs						48 hrs						72 hrs
	Males			Females			Males			Females			Males			Females
	206	28	210	196	13	195	206	28	210	196	13	195	206	28	210	196	13	195
Intact skin
Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Abraded skin
Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

	4 days						8 days
	Males			Females			Males			Females
	206	28	210	196	13	195	206	28	210	196	13	195
Intact skin
Erythema	0	0	0	0	0	0	0	0	0	0	0	0
Oedema	0	0	0	0	0	0	0	0	0	0	0	0
Abraded skin
Erythema	0	0	0	0	0	0	0	0	0	0	0	0
Oedema	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC 1272/2008)

Conclusions:

Not irritating

Executive summary:

In order to calculate the primary irritation index a patch test assay was performed, as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

6 rabbits were shaved one day before treatment with an electric clipper on the flanks. The shaved skin area on the left side was slightly scarified just before treatment. The test substance was applied to each side in quantities of 0.5 ml. The gauze patches were removed 24 hours after application and the reaction of the skin was appraised upon removal during an observation period of 8 days.

Under the test conditions, the test item was found to be non irritant when applied to intact or abraded rabbit skin.

Discussion and conclusion

The scoring system criteria used to record the hardness of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results according to the CLP Regulation (EC 1272/2008), because the raw tables are included into the study report.

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions (in both intact and abraded skin).

In conclusion, the test item can be not classified as irritating, according to the CLP Regulation (EC 1272/2008).