[1-[[(2-hydroxyphenyl)imino]methyl]-2-naphtholato(2-)-N,O,O']copper

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: US FDA - Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959)

Version / remarks:

24h occlusive application

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

[1-[[(2-hydroxyphenyl)imino]methyl]-2-naphtholato(2-)-N,O,O']copper

EC Number:

239-763-1

EC Name:

[1-[[(2-hydroxyphenyl)imino]methyl]-2-naphtholato(2-)-N,O,O']copper

Cas Number:

15680-42-9

Molecular formula:

C17H11CuNO2

IUPAC Name:

[1-[[(2-hydroxyphenyl)imino]methyl]-2-naphtholato(2-)-N,O,O']copper

Details on test material:

Batch: EN 75024
physical state: solid

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Weight: 1,5 - 2 kg
- Housing: housed individually
- Diet : standard diet of Nafag ad libitum
- Water (e.g. ad libitum):drinking water were given "ad libitum"
- acclimatization period: 4 days

Temperature: 22 + 1 °C
Humidity: 55%
Light: 10h/day

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and scarified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

24h, occlusive

Observation period:

72h

Number of animals:

3 males and 3 females

Details on study design:

Approximately 24 hours before treatment an area of about 100 cm2/g body weight was shaved on the back of the rats by means of an electric clipper. The substance was applied by evenly dispersing it on the skin with a syringe and covered with occlusive dressing, which was held around the trunk with an adhesive elastic bandage. After 24 hours the dressings were taken off carefully and the reactions of the skin were appraised upon removal during an observation period of 8 days on the basis of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959).
During this observation period symptoms and mortality were also recorded.

The Draize system for scoring was applied to evaluate erythema and edema.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: animals 1-5 (intact skin)

Time point:

other: 24, 48 and 72h, 4 and 7 days

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

intact skin

Time point:

other: 24h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 3

Irritation parameter:

edema score

Basis:

other: animals 1-6 (intact skin)

Time point:

other: 24 and 72h

Score:

0

Max. score:

4

Any other information on results incl. tables

Table 1: Drazie scores of treated skin at the 24 and 72h readings

animal no			24h	24h	48h	48
			intact skin	scarified skin	intact skin	scarified skin
1	male	Erythema	0	0	0	0
		Edema	0	0	0	0
2	male	Erythema	0	0	0	0
		Edema	0	0	0	0
3	male	Erythema	0	1	0	1
		Edema	0	1	0	1
4	female	Erythema	0	0	0	0
		Edema	0	0	0	0
5	female	Erythema	0	0	0	0
		Edema	0	0	0	0
6	female	Erythema	1	1	0	3
		Edema	0	0	0	0

At the time points of 72h, 4 days and 7 days, all scores were 0.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met