Aluminium tributanolate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

In vitro mutagenicity assessment of aluminium oxide nanomaterials using the Salmonella/microsome assay

Author:

Balasubramanyam A, Sailaja N, Mahboob M, Rahman MF, Hussain SM, Grover P.

Year:

2010

Bibliographic source:

Toxicol In Vitro.Sep;24(6):1871-6 2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Remarks:

Information on GLP is not reported. Quality of the report implies that GLP conditions were met.

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

IUPAC Name:

aluminium oxide

Specific details on test material used for the study:

purity > 90%
particle size: 50-200 um

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 100, TA 1535, TA 98, TA 97a, TA102

Metabolic activation:

with and without

Metabolic activation system:

S9 from male rat liver (no details)

Test concentrations with justification for top dose:

20, 40, 75, 150, 300, 600, 1250 and 2500 ug/plate
Based on the presence of precipitate above 2500 ug/plate

Vehicle / solvent:

vehicle:DMSO/ H2O (1/1)

Controls

Untreated negative controls:

yes

Remarks:

DMSO

Negative solvent / vehicle controls:

yes

Remarks:

DMSO/H2O

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: aminoanthacene

Details on test system and experimental conditions:

METHOD OF APPLICATION: pre-incubation
- Cell density at seeding (if applicable): 1E09 cells/mL

DURATION
- Preincubation period: 30 min
- Exposure duration: 48 hours at 37 °C

NUMBER OF REPLICATIONS: 6

DETERMINATION OF CYTOTOXICITY
- Method: reduction of bacterial background lawn, reduction of revertant colonies

Rationale for test conditions:

standard according to OECD 471

Evaluation criteria:

significant increase of number of revertant colonies compared to controls

Statistics:

NA

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: TA100, TA1535, TA98, TA97a, TA102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

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

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The substance is not mutagenic in the Ames test

Executive summary:

In a test according to OECD 471 Salmonella typhimurium strains TA 100, TA1535, TA98, TA97a and TA102 were exposed to aluminium oxide with and without metabolic activations. No increase in the number of revertants was observed in any of the strains tested. Therefore it is concluded that the substance is not mutagenic.