Copper dihydroxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Copper dihydroxide

EC Number:

243-815-9

EC Name:

Copper dihydroxide

Cas Number:

20427-59-2

Molecular formula:

CuH4O2

IUPAC Name:

copper(2+) dihydroxide

Details on test material:

- Name of test material (as cited in study report): Not stated
- Composition of test material, percentage of components: Not stated
- Lot/batch No.: 0210576133

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Six female New Zealand white rabbits weighing approximately 2.0 to 2.5 kg were housed singly and acclimatised prior to dosing.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

Test material was moistened with deionised water and made into a slurry prior to application.

Controls:

no

Amount / concentration applied:

0.5 g of test material mixed with 0.6 mL of deionised water.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

Six

Details on study design:

On the day prior to application, an area on the dorsal area of the trunk of each animal was shaved free of fur. The following day, 0.5 g of test material mixed with 0.6 mL of deionised water was evenly applied to a 2 x 3 cm gauze surgical patch backed by semi-occlusive tape and an elastic bandage. The complete dressing was then wrapped around the trunk of each animal. After 4 hours, the dressings were removed and any residual test substance was rinsed off with water and a paper towel.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No erythema was recorded. Slight oedema (score 1) was noted in one animal after 30 to 60 minutes which was likely to be due to the compressive bandage. No effects were recorded in other animals or at other assessment times. The mean score (24 to 72 hours) was 0.0.

Other effects:

None.

Any other information on results incl. tables

Table 1. Summary of individual and mean skin irritation scores according to Draize

Assessment time	Scores according to Draize for animal number
	2823	2824	2825	2826	2827	2828
Erythema
30 to 60 mins.	0	0	0	0	0	0
24 hours	0	0	0	0	0	0
48 hours	0	0	0	0	0	0
72 hours	0	0	0	0	0	0
Mean score 24 - 72 hours	0.0
Oedema
30 to 60 mins.	0	1	0	0	0	0
24 hours	0	0	0	0	0	0
48 hours	0	0	0	0	0	0
72 hours	0	0	0	0	0	0
Mean score 24 - 72 hours	0.0

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Copper dihydroxide was not irritating to rabbit skin (means scores 24 to 72 hours for erythema and oedema were 0.0).
Classification according to Directive 67/548/EEC: Not classified.
Classification according to CLP/GHS: Not classified.

Executive summary:

A GLP-compliant study was conducted in accordance with the requirements of US EPA 81-5 without significant deviation. Copper dihydroxide was moistened with deionised water and made into a slurry prior to application. Six female New Zealand white rabbits weighing approximately 2.0 to 2.5 kg were housed singly and acclimatised prior to dosing. On the day prior to application, an area on the dorsal area of the trunk of each animal was shaved free of fur. The following day, 0.5 g of test material mixed with 0.6 mL of deionised water was evenly applied to a 2 x 3 cm gauze surgical patch backed by semi-occlusive tape and an elastic bandage. The complete dressing was then wrapped around the trunk of each animal. After 4 hours, the dressings were removed and any residual test substance was rinsed off with water and a paper towel. Animals were examined for signs of irritation after 30 to 60 minutes and then after 24, 48 and 72 hours, and effects scored according to Draize.

No erythema was recorded. Slight oedema (score 1) was noted in one animal after 30 to 60 minutes which was likely to be due to the compressive bandage. No effects were recorded in other animals or at other assessment times. The mean score (24 to 72 hours) was 0.0. Dicopper dihydroxide is not classified as a skin irritant.