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Toxicological information

Specific investigations: other studies

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Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: DIN EN 1811
GLP compliance:
yes
Type of method:
other: abiotic

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
- Batch No. 32954-109-5
- Storage conditions: room temperature

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Ni-Sb-Ti-oxid treated with acid

Test animals

Species:
other: abiotic test

Administration / exposure

Details on study design:
Determination of Ni, Sb and Ti after elution of the test item in artificial sweat at pH 6.5 (1.0008 g urea, 5.0021 g NaCl and 940 µL lactic acid were dissolved in 900 mL deionised water enriched with O2; pH adjustment with 1% ammonium hydroxide solution) and at pH 8.5 and 1.0 was performed as followed: About 3 mg of the test item was added to 100 mL elution medium. The vessels were covered and heated (without stirring) during one week at 30°C. The pH was measured in each vessel (after 1,2,3, 6 and 7 days) and adjusted to pH if necessary. After 7 days two samples were drawn from each vessel and passed through a 0.22 pm syringe filter, then acidified with HNO3, and analysed for total dissolved metal concentration by inductively coupled plasma - mass spectrometry (ICP-MS).

Results and discussion

Any other information on results incl. tables

Release of metals (d)

Sample name d(Ni) d(Sb) d(Ti)
µg/cm2/Week µg/cm2/Week µg/cm2/Week
artificial sweat #1 <0,0001 <0,0001 0,0001
artificial sweat #2 <0,0001 <0,0001 0,0001
Mean artificial sweat <0,0001 <0,0001 0,0001
pH 8,5 #1 <0,0001 <0,0001 <0,0001
pH 8,5 #2 <0,0001 <0,0001 <0,0001
Mean pH 8.5 <0,0001 <0,0001 <0,0001
pH 1.0 #1 <0,0001 <0,0001 0,0007
pH 1.0 #2 0,0001 <0,0001 0,0007
Mean pH 1.0 0,0001 <0,0001 0,0007

Applicant's summary and conclusion