Registration Dossier
Registration Dossier
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EC number: 231-159-6 | CAS number: 7440-50-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo for skin irritation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline 404 and EU method B.4 The test material has no batch number and no information on purity nor particle size distribution.
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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Coated copper flakes
- IUPAC Name:
- Coated copper flakes
- Details on test material:
- Lot/batch number: not available
Specification: no information was provided on the specification of the sample used in this study
Stability: not available
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.
At the start of the study the animals weighed 2.77 to 3.08 kg and were 12 to 16 weeks old.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: distilled water
- Controls:
- no
- Amount / concentration applied:
- concentration in vehicle: 50% w/v
total volume applied: ca. 1ml - Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3: 2 females and 1 male
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant. no skin irritation was noted in this study
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant. no skin irritation was noted in this study
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant. no skin irritation was noted in this study
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant. no skin irritation was noted in this study
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant. no skin irritation was noted in this study
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant. no skin irritation was noted in this 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 corresponds to the composition of “ copper coated flakes” .
A single 4hr, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation. - Executive summary:
The test material identity was not provided in details. Considering the information from the reports on the same material, the tested material falls in the composition category of "coated copper flakes", consistent with a biocidal product use (PBD notification was the reason for doing the test).
A single 4hr, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation.In this study, copper powder does not meet the criteria for classification for dermal irritation according to Annex VI of Commission Directive 2001/59/EC
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