Blend of Magneli suboxides of titanium

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-01-27 to 1995-02-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

92/69/EEC (Ames)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

416-390-4

EC Name:

-

IUPAC Name:

Blend of Magneli suboxides of titanium

Details on test material:

Black powder, Lot No. Composite 01, Composition : 2% Ti3O5, 49% Ti4O7, 36% Ti5O9, 5% Ti6O11, 8% Ti7O13. The Ebonex Powder used in this experiment differed from the Substance listed in Section 1 in that it contained less Ti4O7 and Ti6O11 and more Ti5O9. It also contained small proportions of Ti3O5, Ti7O13 and Ti8O15. However, the Ebonex Powder used for this study was still a blend of Magneli suboxides of titanium, primarily based upon the same three titanium oxides, Ti4O7, Ti5O9 and Ti6O11 as in the current Ebonex Powder listed in Section 1. As such the results from the Ebonex Powder used in this experiment are considered to be applicable for the current Ebonex Powder as listed in Section 1.

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate

Vehicle / solvent:

Solvent: 2% methyl cellulose

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with

Genotoxicity:

negative

Remarks:

5000 µg/plate

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(> 5000 µg/plate)

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

without

Genotoxicity:

negative

Remarks:

5000 µg/plate

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(> 5000 µg/plate)

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

Observations:
No evidence of mutagenic activity was seen at any dose level of test substance in either mutation test.

Remarks on result:

other: other: preliminary test

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

It is concluded that when the test substance was tested in 2% methyl cellulose, the test material showed no evidence of mutagenic activity in this bacterial system.

Executive summary:

The in vitro assessment of the mutagenic potential of the test substance in 2% methyl cellulose was tested in histidine dependent auxotrophic mutanats of Salmonella trypimurium (strains TA 1535, TA 1537, TA 98 and TA 100).

It is concluded that when the test substance was tested in 2% methyl cellulose, the test material showed no evidence of mutagenic activity in this bacterial system when tested at doe levels of up to 5000 µg/plate.