Dialuminium titanium pentaoxide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 04.Feb.2016 to 18.Mar.2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium oxide

EC Number:

215-691-6

EC Name:

Aluminium oxide

Cas Number:

1344-28-1

Molecular formula:

Al2O3

IUPAC Name:

Aluminium oxide

Test material form:

solid: particulate/powder

Method

Target gene:

Salmonella typhimurium genes (histidine deficiency, UVsensitivity/biotine deficiency, lipopolysaccharide side chain deficiency, ampicillin resistance, teracycline resistance)
hisD6610 (frame shift), hisD3052 (frame shift), hisG46 (base pair substitution), uvrB (deletion), rfa (deletion), pKM101 (plasmid), pAQ1 (plasmid)

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:

S9-Mix

Test concentrations with justification for top dose:

1. experiment (plate incorporation method): 5000/1600/500/160/50 µg/plate
2. experiment (pre-incubation method): 5000/1600/500/160/50 µg/plate
top dose according to guideline for soluble, non-cytotoxic substances
with and without metabolic activitation

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Remarks:

water

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Remarks:

4-nitro-1,2-phenylene, sodium azide, 2-amino-anthracen, benz-o-pyrene

Rationale for test conditions:

according to guideline and coresponding SOP of the laboratory

Evaluation criteria:

A substance is considered to have mutagenic potential, if an increase of revertants colonies exceeding a factor of 2 in at least one strain.

Results and discussion

Test results

Key result

Species / strain:

bacteria, other: salminella thyphimurium TA97a, TA98, TA100, TA102 and TA1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

although the test substance showed small precipitations on the plates

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

In both experiments no mutagenic potential was found under the conditions of this test.

Remarks on result:

not determinable

Remarks:

the test substance is not mutagenic under the conditions of this test

Applicant's summary and conclusion

Conclusions:

no muatgenic potential found under the test conditions of guideline 471