Registration Dossier
Registration Dossier
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EC number: 215-158-8 | CAS number: 1308-14-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Performed to GLP according to recognised methods on Chromium III hydroxide
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Chromium (III) hydroxide
- EC Number:
- 215-158-8
- EC Name:
- Chromium (III) hydroxide
- Cas Number:
- 1308-14-1
- Molecular formula:
- Cr (OH)3
- IUPAC Name:
- chromium (III) hydroxide
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Details on test system:
- Supplier : SkinEthic Laboratories, Lyon, France
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test item was applied topically to the corresponding tissues ensuring uniform covering. 5 μL of sterile distilled water was topically applied to the epidermal surface in order to improve contact between the test item and the epidermis. Approximately 10 mg (26.3 mg/cm2) of the test item was then applied to the epidermal surface
- Duration of treatment / exposure:
- Triplicate tissues were treated with the test item for an exposure period of 15 minutes.
- Number of replicates:
- Three treatment replicates
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- ca. 93
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: Non classified
- Conclusions:
- Not considered irritating to skin
- Executive summary:
The relative mean viability of the test item treated tissues was 93.5% after a 15-Minute exposure period and 42-Hour post-exposure incubation period.
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