Registration Dossier
Registration Dossier
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EC number: 610-765-8 | CAS number: 52013-44-2
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2013
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
Test material
- Reference substance name:
- Nickel, compound with Titanium (1:1)
- EC Number:
- 610-765-8
- Cas Number:
- 52013-44-2
- Molecular formula:
- NiTi
- IUPAC Name:
- Nickel, compound with Titanium (1:1)
- Details on test material:
- 100% Equiatomic NiTi intermetallic compound
Batch 1048
Constituent 1
Test animals
- Species:
- other: human keratinocytes cultured
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Test material: 40 mg +/- 2 mg of the test item were tested neat.
Positive control: 40ul +/- 0.5 ug of SLS 5% in PBS were used .
Negative control: 40ul +/- 0.5 ug of PBS were used . - Duration of treatment / exposure:
- The test item was topically applied on three tissues replicates for 42 minutes at room temperature, exposure was followed by rinsing with phosphate buffer saline and dried, then tissues were transferred to fresh medium and incubated for 42 additional hours at 37°C, 5% CO2.
- Number of animals:
- in vitro test
- Details on study design:
- A three-dimensional RHE tissues, consisting of normal human keratinocytes cultured for 17 days on an inert 0.5 cm^2 plycarbonate filter at the air-liquid interface, was used.
Cell viability determination is based on cellular dehydrogenase activity, measured by MTT reduction and conversion into blue formazan salt that is quantified after extraction from tissues. The percentage reduction in viability is used to predict the irritation potential.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: in vitro results
- Remarks on result:
- other:
- Remarks:
- Remarks: Not irritant for the skin. (migrated information)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of obtained results, according to Official Journal of the European Union 1272/2008 (CLP), OECD no.439 and Skinethic SOP (January 2009, the test item must be considered Not irritant for the skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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