Silicic acid, aluminum magnesium sodium salt

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and Guideline conform; B13.14 is a replicate of OECD 471.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

7/1997

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umweltschutz und Gewerbeaufsicht, Rheinland-Pfalz

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, aluminum magnesium sodium salt

EC Number:

234-919-5

EC Name:

Silicic acid, aluminum magnesium sodium salt

Cas Number:

12040-43-6

Molecular formula:

Na(0.017-1.739)Mg(0.008-0.823)Al(0.002-0.2473)SiO(2.018-3.837)

IUPAC Name:

aluminium(3+) magnesium(2+) sodium tris(oxosilanebis(olate))

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Identification: Silicic acid Aluminium Magnesium Sodium Salt
Batch: code # 1107274003
Purity: > 99%
Appearance: White powder
CAS: 12040-43-6
Expiry Date: November 01, 2018
Storage Conditions: (provided by the Sponsor) At room temperature, moisture protected
Stability: Stable a room temperature

Method

Target gene:

TA97a: hisD6610
TA98: hisD3052
TA100: hisG46
TA102: hisG428
TA1535: hisG46

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium LT2 : TA97a, TA98, TA100, TA102 and TA1535

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

H2O, DMSO and positive Control
First experiment: 5000 / 1500 / 500 / 150 / 50 μg/plate
Second experiment: 5000 / 2500 / 1250 / 625 / 313 μg/plate

Vehicle / solvent:

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

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

Water

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Remarks:

without metabolic activation

Positive control substance:

sodium azide

other: 4-Nitro-1,2-phenylene diamine

Remarks:

Migrated to IUCLID6: and 4-Nitro-1,2-phenylene diamide (6 µg and 80 µg, respectively)

Controls 2

Untreated negative controls:

yes

Remarks:

Water

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Remarks:

with metabolic activation

Positive control substance:

benzo(a)pyrene

other: 2-Amino-anthracene

Remarks:

Migrated to IUCLID6: and 2-Aminoanthracene (40 µg and 3 µg, respectively)

Details on test system and experimental conditions:

First experiment:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Incubation time:
- Incubation temperature: 37 °C

NUMBER OF REPLICATIONS: per strain and dose, four plates with and four plates without S9 mix were used.


Second experiment:
METHOD OF APPLICATION: preincubation

DURATION
- Incubation time: 20 min.
- Incubation temperature: 37 °C

NUMBER OF REPLICATIONS: per strain and dose, four plates with and four plates without S9 mix were used.

Evaluation criteria:

A test item is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor >= 2) in at least one strain can be observed.

Statistics:

A spreadsheet software was used to calculate mean values and standard deviations as well as the increase factor of revertant induction.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: TA 97a, 98, 100, 102 and 1535

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'.

Any other information on results incl. tables

The test item did not show mutagenic effects in both experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants (solvent only).

Cytotoxicity of the test item was not detected. The bacterial background lawn was visible and the number of revertants was not significantly decreased.

As no complete dissolution was possible, undissolved particles were visible on the plates in both experiments in the two highest concentrations.

Therefore it can be stated, that under the test conditions, the test item Silicic acid Aluminium Magnesium Sodium Salt is not mutagenic in the Bacterial Reverse Mutation.

Test using Salmonella typhimurium, strains TA97a, TA98, TA100, TA102 and TA1535.

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative

Silicic acid Aluminium Magnesium Sodium Salt has no mutagenic potential.