Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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 Authorities for Biocides and Existing Substances Regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Copper(II) carbonate--copper(II) hydroxide (1:1)
EC Number:
235-113-6
EC Name:
Copper(II) carbonate--copper(II) hydroxide (1:1)
Cas Number:
12069-69-1
Molecular formula:
CuCO3.Cu(OH)2
IUPAC Name:
copper (II) carbonate, basic
Details on test material:
Test material - Copper carbonate
Lot/batch number - 26694/4/ROX
escription - Green Powder
Purity - Not reported
Stability - Stable at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Source - David Percival Ltd, Moston, Sandbach, Cheshire, UK
Age at test initiation - 12 - 16 weeks old
Weight at test initiation - 2.74-2.90 kg

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: On the day prior to test substance administration, fur of the test animals was clipped free from the dorsal/flank area. No other information was reported.
Vehicle:
water
Remarks:
Distilled
Controls:
not required
Amount / concentration applied:
Test substance was prepared by mixing 0.5 grams of test substance with 0.5 ml of distilled water, immediately before application per animal.
Duration of treatment / exposure:
4-hours
Observation period:
Approximately 1, 24, 48 and 72 hours following removal of the test material, the test sites were examined for evidence of primary irritation.
Number of animals:
3
Details on study design:
EXPOSURE: 0.5 g of test substance was applied to the clipped area and left for 4 hours before the test site was swabbed with distilled water to remove anyresidual material.
SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No other examinations taken.
Other effects:
No other examinations taken.

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 carbonate 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 carbonate moistened with distilled water to intact skin. Irritancy was determined 1, 24, 48 and 72 hours after the test substance was removed.

 

The study was conducted according to Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation), OECD Guidelines for the Testing of Chemicals No. 404 'Acute Dermal Irritation/Corrosion' (adopted 17 July 1992) and EPA Health Effects Test Guidelines OPPTS 870.2500 Acute Dermal Irritation. August 1998. The study was also conducted according to GLP. No deviations from the test guidelines, or deficiencies in the method were reported.

Results and conclusions

The 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.