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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:
1988

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): Copper hydroxide
- Composition of test material, percentage of components: Not stated.
- Lot/batch No.: Not stated.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
New Zealand white rabbits (sex not stated) weighing 2.0 to 3.0 kg were housed singly and acclimatised prior to dosing.

Test system

Type of coverage:
other: non-occlusive
Preparation of test site:
other: clipping
Vehicle:
water
Remarks:
The test material was moistened with deionised water prior to application.
Controls:
not specified
Amount / concentration applied:
0.5 grams
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 clipped free of fur. The following day, 0.5 g of test material was applied to the intact skin on each rabbit under a two-layer cotton gauze patch 2.5 x 2.5 cm in size. The trunk of the animal was wrapped with a non-occlusive dressing. After 4 hours, the dressings were removed and any residual test substance was rinsed off with water.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Slight erythema (score 1) was noted in all animals after 24 hours. No effects were recorded at other assessment times. The mean score (24 to 72 hours) was 0.3. No oedema was recorded.
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

8695

8678

8681

8640

8641

8642

Erythema

5 hoursa

0

0

0

0

0

0

24 hours

1

1

1

1

1

1

48 hours

0

0

0

0

0

0

72 hours

0

0

0

0

0

0

Mean score per animal 24 – 72 hrs

0.3

0.3

0.3

0.3

0.3

0.3

Mean score all animals 24 - 72 hrs

0.3

Oedema

5 hoursa

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 per animal 24 – 72 hrs

0

0

0

0

0

0

Mean score all animals 24 - 72 hrs

0.0

a        Assessment 5 hours after beginning of exposure (one hour after the end of exposure).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Copper dihydroxide was only slightly irritating to rabbit skin (mean scores 24 to 72 hours for erythema and oedema across all animals tested were 0.3 and 0.0, respectively.
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 prior to application. Six New Zealand white rabbits weighing 2.0 to 3.0 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 clipped free of fur. The following day, 0.5 g of test material was applied to the intact skin on each rabbit under a two-layer cotton gauze patch 2.5 x 2.5 cm in size. The trunk of the animal was wrapped with a non-occlusive dressing. After 4 hours, the dressings were removed and any residual test substance was rinsed off with water. Animals were examined for signs of irritation 5 hours after the beginning of exposure and then at 24, 48 and 72 hours, and effects scored according to Draize.

 

Slight erythema (score 1) was noted in all animals after 24 hours. No effects were recorded at other assessment times. The mean score (24 to 72 hours) was 0.3. No oedema was recorded. Copper dihydroxide is not classified as a skin irritant.