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

Endpoint summary

Description of key information

The substance is not irritating to the skin and eyes of rabbits as tested in studies performed to protocols equivalent to OECD testing guidelines OECD 405 and 404. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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

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

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.

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

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

intact skin

Time point:

other: 24h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48h

Irritation parameter:

edema score

Basis:

other: animals 1-6 (intact skin)

Time point:

other: 24 and 72h

Score:

0

Max. score:

4

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.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

In three of six animals, eyes were rinsed with physiological saline 30 seconds after treatment., 7 day observation period

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)

GLP compliance:

no

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany
- Age at study initiation:
- Weight at study initiation: 1.5 - 2 kg
- Housing: individual cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 1 °C
- Humidity (%): 55 +/- 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day

IN-LIFE DATES: no data

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1g

Duration of treatment / exposure:

single treatment. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.

Observation period (in vivo):

The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 of the 6 rabbits
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Irritation parameter:

cornea opacity score

Basis:

animal: 1,2,3,4,5,6

Time point:

other: days 1,2,3,4,7

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal: 1,2,3,4,5,6

Time point:

other: days 1,2,3,4,7

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal: 1,2,3,4,5,6

Time point:

other: days 1,2,3,4,7

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal: 1,2,3,4,5,6

Time point:

other: days 1,2,3,4,7

Score:

0

Max. score:

4

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The pigment has been tested for skin and eye irritiaton in rabbits in 1978.

For the eye irritation studies, the procedures differ from the OECD guideline in a shorter observation period of 7 days. Considering that all scores were zero at all time points, it is not expected that a longer observation period would have revealed a hazard.

For the skin irritation studies, the procedures are more stringent than the OECD guideline 404 since the exposure lasts 24h. For half of the animals, the skin was scarified. The observation period is shorter and only readings at 24h and 72h are reported. Since all scores at 72h were 0 and individual scores were not higher than 1, it is acceptable to have the shorter observation period.

The test materials tested were not characterised for the presence of particles in the nano-size range. However, since no organic pigment was ever identified as a skin or eye irritant, the lack of the characterization of the particle properties is not relevant for the assessment of irritation.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.