Registration Dossier
Registration Dossier
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EC number: 238-475-3 | CAS number: 14481-26-6
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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dipotassium titanium oxide dioxalate
- EC Number:
- 238-475-3
- EC Name:
- Dipotassium titanium oxide dioxalate
- Cas Number:
- 14481-26-6
- Molecular formula:
- C4K2O9Ti
- IUPAC Name:
- dipotassium oxotitaniumbis(ylium) dioxalate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 16 mg
- Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours and 30 minutes post-treatment incubation period
- Number of replicates:
- 3 living reconstructed human epidermis
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 86.8
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with the Regulation EC No 1272/2008, the test item Oxalate de Titanyl Potassium has to be considered as non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required.
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