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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:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dicopper chloride trihydroxide
EC Number:
215-572-9
EC Name:
Dicopper chloride trihydroxide
Cas Number:
1332-65-6
Molecular formula:
ClCu2H3O3
IUPAC Name:
dicopper chloride trihydroxide
Details on test material:
- Name of test material (as cited in study report): Copper oxychloride
- Composition of test material, percentage of components: 57.72% w/w copper
- Lot/batch No.: 31762/86

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Rabbits weighing 2.156 to 2.829 kg were acclimatised prior to dosing.

Test system

Type of coverage:
other: refer to details on study design.
Preparation of test site:
other: clipping.
Vehicle:
water
Remarks:
test material was moistened with distilled water.
Controls:
yes, concurrent vehicle
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 approximately 10 x 15 cm on the dorsal area of the trunk of each animal was clipped free of fur. On the day of application, 0.5 g of test material moistened with 0.5 mL distilled water was applied to the intact skin on the left side of each rabbit on a gauze patch. The patch was held in place by a waterproof plaster wrapped around the trunk. The right side of each animal was treated in the same way with a patch with 0.5 mL of distilled water only. Elizabethan collars were fitted to all animals. After 4 hours, the dressings were removed and the treated sites gently washed to remove any residual test substance.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
Following application of copper oxychloride, slight erythema (score 1) was noted in one animal after 30 minutes, and in two animals after 1 and 24 hours. No erythema was recorded after 48 or 72 hours. The mean score (24 to 72 hours) was 0.1. No oedema was recorded. The results are summarised in Table 1. The results of the distilled water only treatment are not presented in the report.
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

1

3

5

7

9

11

Erythema

30 mins.

1

0

0

0

0

0

1 hour

1

0

0

0

1

0

24 hours

1

0

0

1

0

0

48 hours

0

0

0

0

0

0

72 hours

0

0

0

0

0

0

Mean score per animal 24 - 72 hours

0.3

0

0

0.3

0

0

Mean score all animals 24 -72 hours

0.1

Oedema

30 mins.

0

0

0

0

0

0

1 hour

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 hours

0

0

0

0

0

0

Mean score all animals 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:
Dicopper chloride trihydroxide was slightly irritating to rabbit skin (mean scores for all animals at 24 to 72 hours for erythema and oedema were 0.1 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 EC Guideline B.4, OECD 404 and US EPA 40 CFR Section 798.4470 without significant deviation. Dicopper chloride trihydroxide was moistened with distilled water prior to application. Six female New Zealand white rabbits weighing 2.156 to 2.829 kg were acclimatised prior to dosing. On the day prior to application, an area approximately 10 x 15 cm on the dorsal area of the trunk of each animal was clipped free of fur. On the day of application, 0.5 g of test material moistened with 0.5 mL distilled water was applied to the intact skin on the left side of each rabbit on a gauze patch. The patch was held in place by a waterproof plaster wrapped around the trunk. The right side of each animal was treated in the same way with a patch with 0.5 mL of distilled water only. Elizabethan collars were fitted to all animals. After 4 hours, the dressings were removed and the treated sites gently washed to remove any residual test substance. Animals were examined for signs of irritation after 30 and 60 minutes, and after 24, 48 and 72 hours, and effects scored according to Draize.

Following application of dicopper chloride trihydroxide, slight erythema (score 1) was noted in one animal after 30 minutes, and in two animals after 1 and 24 hours. No erythema was recorded after 48 or 72 hours. The mean score across all animals (24 to 72 hours) was 0.1. No oedema was recorded. Dicopper chloride oxychloride is not classified as a skin irritant.

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