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Toxicological information

Skin irritation / corrosion

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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:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
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.