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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: Already evaluated by the Competent Authority for Biocides and Existing Substances Regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot/Batch number: 02-0084
Description: Brown/black powder
Purity: 97.7% cupric oxide
Stability: Stable at room temperature.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
Sex: Male
Age at study initiation: At the start of the study, the mean bodyweights were reported to be 2-3.5 kg and the ages ranged from 12 - 16 weeks old.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: On the day before the test, the dorsal/flank area was clipped to remove all fur.
Vehicle:
water
Remarks:
Distilled water.
Controls:
other: No, untreated skin areas acted as a control.
Amount / concentration applied:
Concentration in vehicle: Not applicable.
Total volume applied: 0.5 g of test material, moistened with distilled water, was placed under a 2.5 cm x 2.5 cm cotton gauze patch and placed on the
shorn skin.
Duration of treatment / exposure:
Duration of exposure: 4 hours
Observation period:
Postexposure period: 72 hours
Number of animals:
Number of animals per group: 3.
Details on study design:
Preparation of test substance: Test substance was prepared by mixing 0.5 grams of test substance with 0.5 ml of distilled water, immediately before
application.
Removal of test substance: Any residual test material was removed with 74% Industrial Methylated Spirits.
Scoring system: Draize scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

Overall result: There was no evidence of skin irritation noted during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not meet the criteria for classification as irritant or corrosive to skin according to the EU labelling regulations Commission
Directive 93/21/EEC.
Executive summary:

Materials and Methods

This study was conducted to assess the irritancy potential of copper oxide to the skin of the New Zealand White rabbit. A group of 3 male New Zealand White rabbits were given a single, 4-hour, semi-occluded dermal application of copper oxide (0.5 g moistened with 0.5 ml of distilled water) to intact skin clipped free of fur. Irritancy was determined 1, 24, 48 and 72 hours after the test substance was removed.

 

The study was conducted according to OECD Guidelines for the Testing of Chemicals No. 404 'Acute Dermal Irritation/Corrosion' (adopted 17 July 1992) and Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation). The study was also conducted according to GLP.

 

No deviations from the test guidelines, or deficiencies in the method were reported. Results and DiscussionThe test material produced a primary irritation index of 0.0 and was classified as NON IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.