Nickel, compound with Titanium (1:1)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 6 - August 21, 2013

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Weight range: 188-219 g at the beginning of the assay
Supplier: Harlan, Correzzana (MB)
Food: global diet
Bedding: lignocell

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The substance has been used neat. The wire has been cut and then applied on the skin.
24 hours before the test the back and the sides of the animals have been shaved on an area of about 20 cm^2.
The test sample has been given with a square of gauze directly on animals' skin humidified with sodium chloride injection and fixed with a skin patch in a area of about 10% of the total body surface. The square is fixed with hypo-allergenic occlusive adhesive tape.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

10 rats (5 males and 5 females)

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the general status of all animals has been monitored on the day of dosing (30 min, 2h and 4h) and daily (5 days per week) for 14 days.
Animals have been weighted before experiment, after 7 days and at the end of the experiment.
Clinical observation included:
-assessment of major organic functions
-assessment of the status of integumentary apparatus
-assessment of the status of mucosae
-assessment of somato-motory activity and of the sensory status
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality has been detected.

Clinical signs:

Neither symptoms nor signs of toxicity were recorded.

Body weight:

Treated animals' weight was complied with the standard of species and race in first and in the second week of the study.

Gross pathology:

No particular abnormalities have been detected.

Applicant's summary and conclusion

Interpretation of results:

not classified

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) and OECD no.402, the test item has a LD50 > 2000 mg/kg bw and can be considered Non toxic - not harmful.