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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bettinardi - Momo (NO)
- Weight at study initiation: 300-321 g. at the beginning of the test
- Housing: the animals were caged in groups of five in transparent polycarbonate cages.
- Diet (e.g. ad libitum): standard pellet
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod: 12 hrs dark / 12 hrs light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
cotton seed oil
Remarks:
and sodium chloride
Concentration / amount:
weight/volume ratio of 0.2 g/ml
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
cotton seed oil
Remarks:
and sodium chloride
Concentration / amount:
weight/volume ratio of 0.2 g/ml
No. of animals per dose:
Two groups of 10 animals treated with the test substance and 5 animals used as control.
Details on study design:
Two extracts were performed by dipping completely the test item in order to reach a weight/volume ration of 0.2 g/ml and incubating it for 72 hours at a temperature of 37°C +/- 1 °C in dynamic control.
Induction phase:
The guinea pigs was treated with 3 (0.1 ml each one) double intradermal injections:
1. 50:50 (v:v) stable emulsion of Freund's complete adjuvant mixed with the solvent
2. the treated animals injected with undiluted extract; the control animals injected with the solvent alone
3. the treated animals injected with undiluted extract, emulsified in a 50:50 (v/v) stable emulsion of Freund's complete adjuvant and the solvent (50%); the control animals injected with an emulsion of the solvent sith adjuvant.

6 days after the beginning of treatment on the all animals, a topical application, with slight massage, of 1 ml of Sodium Lauril Solfatum 10% was performed.
After 47 days from intradermal injections, the extracts of test product were applied (at a dose of 0.5 ml/animal) to the skin of the 10 treated animals for a period of 48 hours. The same treatment was performed on control guinea pigs using only extraction liquid.

Challenge controls:
Challenge phase:
21 days after the beginning of treatment, the challenge phase was performed applying the extracts of test product (at a dose of 1 ml/animal) on the right side of each animal and about 0.5 ml of the solvent on the left side. The patch was left on for 24 hours.
48 and 72 hours after the beginning of this phase, the tested animals and the control animals were observed.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities were observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No abnormalities were observed.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0.
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

No abnormalities were observed in treated and control animals during the challenge phase.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of obtained results, according to OECD no.406 and interpreted according to Official Journal of the European Union 1272/2008 (CLP), the test item can be considered Not sensitizing.