Silicic acid, aluminum sodium salt, sulfurized

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: OECD guideline 471. GLP study.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, aluminum sodium salt, sulfurized

EC Number:

309-928-3

EC Name:

Silicic acid, aluminum sodium salt, sulfurized

Cas Number:

101357-30-6

Molecular formula:

|Na+6-x+y+z (S2•-)y(S3•-)z|[Al6-x Si6+x O24] - SOD Where: 6 ≤ 6-x+y+z ≤ 8 0 ≤ x ≤ 1.2 1 ≤ y+z ≤ 2

IUPAC Name:

Silicic acid, aluminum sodium salt, sulfurized

Details on test material:

- Name of test material : Ultramarine Blue, C.I. Pigment Blue 29
- Material at sunlight until use, kept at room temperature away from heat and moisture

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

-Identity of media: Center of Japanese Baioatsusi

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Details on mammalian cell type (if applicable):

-Identity of media: Center of Japanese Baioatsusi

Metabolic activation:

with and without

Metabolic activation system:

S9 from rat liver

Test concentrations with justification for top dose:

Test material dose:
0.50 - 1.50 - 5.00 - 15.00 - 50.00 mg/mL (313, 625, 1250, 2500, 5000 µg/plate)

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Remarks:

water for injection

True negative controls:

no

Positive controls:

yes

Remarks:

without metabolic activation

Positive control substance:

other: 2,2-(2-Furyl)-3-(5-nitro-2fuiyl)acrylamide

Remarks:

TA 100, WP2 uvrA- 2,2-(2-Furyl)-3-(5-nitro-2fuiyl)acrylamide: 0.01 µg/plate

Controls 2

Negative solvent / vehicle controls:

yes

Remarks:

water for injection

True negative controls:

no

Positive controls:

yes

Remarks:

without metabolic activation

Positive control substance:

other: 2,2-(2-Furyl)-3-(5-nitro-2fuiyl)acrylamide

Remarks:

TA 98- 2,2-(2-Furyl)-3-(5-nitro-2fuiyl)acrylamide: 0.1 µg/plate

Controls 3

Negative solvent / vehicle controls:

yes

Remarks:

water for injection

True negative controls:

no

Positive controls:

yes

Remarks:

without metabolic activation

Positive control substance:

sodium azide

Remarks:

TA 1535- sodium azide: 0.5µg/plate

Controls 4

Negative solvent / vehicle controls:

yes

Remarks:

water for injection

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA 1537- 9-aminoacridine: 80µg/plate

Migrated to IUCLID6: without metabolic activation

Controls 5

Negative solvent / vehicle controls:

yes

Remarks:

water for injection

True negative controls:

no

Positive controls:

yes

Remarks:

with metabolic activation

Positive control substance:

other: 2-Aminoanthracene

Remarks:

TA 100 - 2-Aminoanthracene: 1µg/plate

Controls 6

Negative solvent / vehicle controls:

yes

Remarks:

water for injection

True negative controls:

no

Positive controls:

yes

Remarks:

with metabolic activation

Positive control substance:

other: 2-Aminoanthracene

Remarks:

TA 1535, TA 1537- 2-Aminoanthracene: 2µg/plate

Controls 7

Negative solvent / vehicle controls:

yes

Remarks:

water for injection

True negative controls:

no

Positive controls:

yes

Remarks:

with metabolic activation

Positive control substance:

other: 2-Aminoanthracene

Remarks:

WP2 uvrA- 2-Aminoanthracene: 10 µg/plate

Controls 8

Negative solvent / vehicle controls:

yes

Remarks:

water for injection

True negative controls:

no

Positive controls:

yes

Remarks:

with metabolic activation

Positive control substance:

other: 2-Aminoanthracene

Remarks:

TA 98- 2-Aminoanthracene: 0.5 µg/plate

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium made of minimal glucose agar
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

Results and discussion

Test results

Test results 1

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

Positive controls validity:

valid

Test results 2

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

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

The result was that the test material is not mutagenic.

Executive summary:

The aim of the test was to assess the potential of test material to induce a point mutation at the histidine-requiring gene locus in strains of Salmonella typhimurium and E.coli.

The test procedure used was the OECD guideline 471.

Test material doses were: 0.50 - 1.50 - 5.00 - 15.00 - 50.00 mg/mL

The result was that the test material is not mutagenic.

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