Diindium trioxide

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Differential genotoxicity of chemical properties and particle size of rare metal and metal oxide nanoparticles.

Author:

Hasegawa G, Shimonaka M and Ishihara Y

Year:

2012

Bibliographic source:

J Appl Toxicol. 32(1):72-80

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Remarks:

GLP compliance not specified in publication

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Diindium trioxide

EC Number:

215-193-9

EC Name:

Diindium trioxide

Cas Number:

1312-43-2

Molecular formula:

In2O3

IUPAC Name:

bicyclo[1.1.1]diindoxane

Details on test material:

In2O3:
purity: >99.99%
mean diameter in solution: >7µm
impurities: Cu: 10.1 ppm, Fe: 5.9ppm, Na: 5.3ppm, Mg: 5.0ppm, Ca: 2.1ppm, Zn: 0.4ppm, Ni: 0.3ppm

Method

Target gene:

not applicable

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

80; 60; 40; and 20 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ultrapure water

Controls

Untreated negative controls:

yes

Remarks:

ultrapure water

Negative solvent / vehicle controls:

yes

Remarks:

ultrapure water

True negative controls:

no

Positive controls:

yes

Remarks:

With S9mix: 2-AA (TA 100; TA 1535, TA 1537, TA98 and WP2µvrA. Without S9 mix: AF-2 (TA 100, TA 98 and WP2µvrA), NaN3 (TA 1535), 9-AA (TA 1537)

Positive control substance:

9-aminoacridine

sodium azide

furylfuramide

other: 2-AA (2-aminoanthracene)

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20min at 37°C and 8hr at 37°C


NUMBER OF REPLICATIONS: The test was performed in duplicate for each concentration of particle suspension.

Evaluation criteria:

the test results were considered to show significant mutagenic activity when a 2-fold increase in the number of the revertant colonies in treated plates over the solvent control plates was observed.

Statistics:

Two-way ANOVA with Fisher's protected least significant difference was employed to compare the mean values between two groups. A p-value of <0.05 was considered to indicate a statistically significant difference.

Results and discussion

Test results

Test results 1

Key result

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

Test results 2

Key result

Species / strain:

E. coli WP2 uvr A

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

Additional information on results:

none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Conclusions:

The test material was considered to be non-mutagenic for all the used bacterial strains (Salmonella typhimurium as well as Escherichia coli) with as well as without metabolic activation

Executive summary:

A study was conducted to determine the potential mutagenicity of the test material using bacterial reverse mutation assay (e.g. Ames test). 

No significant increases in the frequency of revertant colonies were recorded at any dose level.

 

The test material was considered to be non-mutagenic under the conditions of this test.