Registration Dossier
Registration Dossier
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EC number: 235-113-6 | CAS number: 12069-69-1
Skin irritation / corrosion
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:
- 2 001
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
- 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
Constituent 1
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.
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