Registration Dossier
Registration Dossier
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EC number: 235-049-9 | CAS number: 12062-81-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: short report - test was conducted with (Fe, Mn)3O4 (CAS 68186-94-7) as a surrogate for (Fe,Mn)2O3
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Due to the age of the study, deficiencies in study conduct and reporting.
- Principles of method if other than guideline:
- 500 mg/animal were applied onto the ear, washing of the ear; post observation period: 7 days
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Manganese ferrite black spinel
- EC Number:
- 269-056-3
- EC Name:
- Manganese ferrite black spinel
- Cas Number:
- 68186-94-7
- Molecular formula:
- (Fe,Mn)3O4
- IUPAC Name:
- manganese ferrite black spinel
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3 - 4 kg
- Housing: individual
- male and female
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/ animal - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 7 days
- Number of animals:
- 2
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:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 48 and 72 h not determined; after 24 h and on days 4, 5, 6, and 7 no effects
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 48 and 72 h not determined; after 24 h and on days 4, 5, 6, and 7 no effects
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The test item is not irritating to the skin and does not require classification and labelling.
- Executive summary:
- 500 mg/animal were applied onto the ear, washing of the ear; post observation period: 7 days Result: not irritating
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