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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

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.