Registration Dossier
Registration Dossier
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EC number: 234-974-5 | CAS number: 12047-11-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study has been properly conducted, in accordance with recommended guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EU method B.40bis
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 431 Guideline
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Barium dodecairon nonadecaoxide
- EC Number:
- 234-974-5
- EC Name:
- Barium dodecairon nonadecaoxide
- Cas Number:
- 12047-11-9
- Molecular formula:
- Ba.Fe12O19
- IUPAC Name:
- dodecairon(3+) barium(2+) nonadecaoxidandiide
- Details on test material:
- Sample 10.058461.01 was tested.
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: human skin model (EPISKIN)
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- water
- Controls:
- other: Negative control: water
- Amount / concentration applied:
- For test sample 25 mg of substance was applied evenly to cover the skin, and it was moistened with distilled water to ensure good contact with the skin.
- Duration of treatment / exposure:
- The assessment of skin corrosivity was carried out in two contact times according to OECD 431: 3 min and 1 h.
- Observation period:
- At the end of the exposure period, each tissue insert was washed with DPBS for twenty times from the skin surface. Every tissue replicate was treated in 0.3 ml of MTT solution 1 mg/mL. The plate was incubated for 3 hr at 37°C ± 1°C 5 % CO2. At the end of incubation each tissue insert was treated with 2ml of Isopropyl alcohol (dark, T room, overnight). Two replicates of extract solution (200 μl) were put into microplate’s wells and the optical density (OD) of the extracted (solubilised) dye at 570 nm was evaluated.
- Number of animals:
- For each contact time, three tissue replicates were used for sample treatment, three for positive control and three for the negative one.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Cell viability (%) after application of the test substance
- Value:
- 98.78
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: Contact time 3 min. Remarks: Viability (%) = (mean OD570 / mean OD570 negative control) x 100. (migrated information)
- Irritation / corrosion parameter:
- other: other: Cell viability (%) after application of the positive control
- Value:
- 22.06
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: Contact time 3 min. Remarks: Viability (%) = (mean OD570 / mean OD570 negative control) x 100. (migrated information)
- Irritation / corrosion parameter:
- other: other: Cell viability (%) after application of the test substance
- Value:
- 100.07
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: Contact time 1 h. Remarks: Viability (%) = (mean OD570 / mean OD570 negative control) x 100. (migrated information)
- Irritation / corrosion parameter:
- other: other: Cell viability (%) after application of the positive control
- Value:
- 0.56
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: Contact time 1 h. Remarks: Viability (%) = (mean OD570 / mean OD570 negative control) x 100. (migrated information)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to "In vitro Skin Corrosion Human Skin Model Test" Barium Hexaferrite was not corrosive for skin.
- Executive summary:
Barium hexaferrite was tested in an in vitro model for skin corrosion (EPISKIN) according to EU B.40bis/OECD 431 guidelines. The substance was not corrosive for the skin.
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