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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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 oxide sulphate
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
Controlsopen allclose all
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
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
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
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
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.