Registration Dossier
Registration Dossier
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EC number: 701-480-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study performed according to internationally accepted method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Study was performed to evaluate the potential skin irritant effects of copper slag based on EU B4 method - Acute toxicity - Skin irritation. The tested substance was applied in a single dose on the skin of laboratory animals, using the untreated skin areas as control.
- GLP compliance:
- no
- Remarks:
- other quality assurance
Test material
- Reference substance name:
- Iron silicate, copper smelting and refining
- EC Number:
- 701-480-0
- Cas Number:
- 67711-92-6
- IUPAC Name:
- Iron silicate, copper smelting and refining
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Rabbit healthy adult male albino
The diet was standard for these animals. Animal house temperature was maintained at 20 + / - 2c, the relative humidity was between 30 -70% and photoperiod was 12/12 hours light / dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- single dose
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No formation of erythema observed
No formation of edema observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- This is a good quality study. The sample is not skin irritant
- Executive summary:
Study was performed to evaluate the potential skin irritant effects of copper slag based on EU B4 method - Acute toxicity - Skin irritation.
Based on the results, copper slag is not skin irritant. The absence of irritation effects furthermore excludes the possibility of corrosion, defined as a strategic destruction of tissues throughout the skin thickness
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