Titanium oxide sulphate

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:

1991-02-08 to 1991-03-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study reliable without restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1983

Deviations:

no

GLP compliance:

yes

Remarks:

The study report states that the study was conducted in compliance with OECD Principles of Good Laboratory Practice (Bundesanzeiger Nr. 42a, of the 2nd of March 1983 and Bundesgesetzblatt, Part I, of the 22nd of March 1990.

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Titanium oxide sulphate

EC Number:

237-523-0

EC Name:

Titanium oxide sulphate

Cas Number:

13825-74-6

Molecular formula:

O5STi

IUPAC Name:

Titanium(IV) Oxysulfate

Constituent 2

Reference substance name:

oxotitanium; sulfuric acid

IUPAC Name:

oxotitanium; sulfuric acid

Details on test material:

- Name of test material (as cited in study report): Titanylsulfate
- Physical state: brown liquid
- Storage condition of test material: refrigerator
- Stability under test conditions: The batch used was analysed prior to the study initiation and approved for use during the test period. A stability test in the solvent did not detect a relevant change in the percent active ingredient.

No further details were stated.

Method

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

other: histidine deficiant, ampicillin resistant, crystal-violet sensitiv, UV sensitiv

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

Range finding dose: 5000, 1000, 200 , 40, 8 µg/plate
Doses: 4800, 2400, 1200, 600, 300, 150 and 75 µg/plate

Vehicle / solvent:

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

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA 1535

Migrated to IUCLID6: 10 µg

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 0.2 µg nitrofurantoin

Remarks:

TA 100

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 10 µg 4-nitro-1,2-phenylene diamine

Remarks:

TA 1537

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 0.5 µg 4-nitro-1,2-phenylene diamine

Remarks:

TA 98

Controls 5

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 3 µg 2-aminoanthracene

Remarks:

promutagen reverts all strains and serves as control for activating effect of S9 mix

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 4
DETERMINATION OF CYTOTOXICITY
- Method: gross appraisal of background growth, marked and dose-dependent reduction in mutant count per plate compared to negative controls, titer determination

Evaluation criteria:

criteria for positive result is a reproducible and dose-related increase in mutant counts of at least one strain: for TA 1535, TA 100, TA 98 increase about twice the amount of negative controls, respectively for TA 1537 threefold. Otherwise the result is negative.

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Results show that the test substance has neither a cytotoxic nor a genotoxic effect under the given test conditions.

Executive summary:

The purpose of the study was to evaluate the potential of test item titanium oxide sulphate for inducing bacterial reverse mutation. The study followed the protocol as given by OECD Guideline 471 (Ames Test). Test concentrations applied were 4800, 2400, 1200, 600, 300, 150 and 75 µg/plate. Results show that the test substance has neither a cytotoxic nor a genotoxic effect under the given test conditions. Reliabl result, as all controls reported to be valid.