Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye 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
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
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
Physical State: free wire
Colour: black
Batch 1048
Expiry Date: not applicable

Test animals / tissue source

Species:
other: bovine corneal

Test system

Controls:
other: 3 corneas as positive control treated with ethanol 100%
Amount / concentration applied:
The test item was extracted and the test item extract was tested at 100% concentration.
The extraction of the test item was performed according to ISO 10993-12 [8].
In total a ratio of 60 cm2 of sample to 20 mL of extraction medium was used.
The test item was extracted under agitation at 37 ± 1 °C for 72 ± 2 h
The extraction vehicle was physiological saline 0.9% NaCl, B. Braun Melsungen, lot no. 13014404, expiry date: 12/2015
After the extraction procedure neither the test item nor the extraction medium showed any abnormalities. No turbidity, no colour changes and no particles occurred in the extraction medium.
Number of animals or in vitro replicates:
Test Groups
3 corneas for the test item
3 corneas as negative controls treated with physiological saline 0.9% NaCl
3 corneas as positive control treated with ethanol 70%
3 corneas as positive control treated with ethanol 100%
The BCOP assay is considered to be valid if the in vitro irritation score obtained with the positive control falls within the two standard deviations of the current historical mean.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks:
in vitro
Basis:
mean
Score:
-0.57
Reversibility:
not specified
Remarks on result:
other: non irritant

Any other information on results incl. tables

The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the evaluation criteria the test item Nitinol H/W/1.000/C is classified as non-irritant to eyes.