Antimony nickel titanium rutile

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Antimony nickel titanium rutile

EC Number:

701-459-6

Cas Number:

8007-18-9

Molecular formula:

Ni(x/3)Sb(2x/3)Ti(1-x)O2 0,1≤x≤0,3

IUPAC Name:

Antimony nickel titanium rutile

Test material form:

solid

Specific details on test material used for the study:

- Batch No.: 4879

Method

Species / strain

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

rat liver induced with phenobarbital and 5,6-benzoflavone.

Test concentrations with justification for top dose:

short-term treatment (-S9 mix): 4.88, 9.77, 19.5, 39.1, 78.1 µg/mL;
short-term treatment (+S9 mix): 19.5, 39.1, 78.1, 156, 313, 625, 1250 µg/mL;
continuous treatment (-S9 mix): 4.88, 9.77, 19.5, 39.1, 78.1 µg/mL

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: -S9: Mitomycin C; +S9: Cyclophosphamide

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

NUMBER OF CELLS EVALUATED: 200

Evaluation criteria:

The results were judged to be: negative in the case where the appearance frequency of abnormal cells was less than 5 %; equivocal in the case where the frequency was 5 % or more and less than 10 % and also the reproducibility was observed; and positive in the case where the frequency was 10 % or more and also the reproducibility or the dependency on the test substance dose was observed.

Results and discussion

Test results

Key result

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Cytotoxicity was observed at more than 39.1, 78.1, and 19.5 µg/mL in -S9 mix, +S9 mix and continuous treatments, respectively.

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified