Ammonium hexafluorosilicate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

in vivo insect germ cell study: gene mutation

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

no guideline mentioned

GLP compliance:

not specified

Specific details on test material used for the study:

sodium hexafluorosilicate from Fisher Scientific Co., Fair Lawn, NJ (U.S.A.)

Species:

Drosophila melanogaster

Details on species / strain selection:

The Berlin K (wild-type) and Base strains were used.

Sex:

male/female

Route of administration:

oral: feed

Vehicle:

in 5% saccharose

Details on exposure:

In Drosophila one dose close to the LD50, was applied by the adult feeding method.

Duration of treatment / exposure:

3 successive broods (3-3-4 days)

Dose / conc.:

0.25 other: mM

Control animals:

yes

Positive control(s):

trenimon

Additional information on results:

Sex-linked recessive Iethals/chromosomes tested and percentage:
Brood 1: 3/1226 (0.24); control: 19/7130 (0.27)
Brood 2: 1/1224 (0.08); control: 8/5525 (0.14)
Brood 3: 2/1236 (0.16); control: 19/4871 (0.39)

Conclusions:

Sodium hexaflurosilicate showed constantly slighter effects on drosophila than control over three generations.

Cross-reference 2

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

genetic toxicity in vivo, other

Remarks:

micronucleus

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

no guideline mentioned

GLP compliance:

not specified

Specific details on test material used for the study:

sodium hexafluorosilicate from Fisher Scientific Co., Fair Lawn, NJ (U.S.A.)

Species:

mouse

Strain:

NMRI

Details on species / strain selection:

Mice were obtained from S. Ivanovas GmbH and Co., Kisslegg/Allgäu (Germany)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals were given standard chow (Altromin GmbH, Lage, Germany) and water ad libitum.

Route of administration:

intraperitoneal

Frequency of treatment:

once

Dose / conc.:

37.6 mg/kg bw (total dose)

No. of animals per sex per dose:

4 animals per dose (sex not specified)

Control animals:

yes, concurrent no treatment

Additional information on results:

Micronucleated polychromatic erythrocytes:
trearted: 0.2 %
control: 0.22 %

Conclusions:

The effect was shown slightly more in control than in treated mice, therefore the substance was concluded to be not mutagenic.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Principles of method if other than guideline:

no guideline mentioned

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium hexafluorosilicate

EC Number:

240-968-3

EC Name:

Ammonium hexafluorosilicate

Cas Number:

16919-19-0

Molecular formula:

F6Si.2H4N

IUPAC Name:

diammonium hexafluorosilicate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

sodium hexafluorosilicate from Fisher Scientific Co., Fair Lawn, NJ (U.S.A.)

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA1535, TA100, TA1538, TA98 and TA1537

Metabolic activation:

with and without

Metabolic activation system:

S9 liver fraction from Aroclor-pretreated rats

Test concentrations with justification for top dose:

Tests were performed according to standard procedures. In the Ames assay at least 5 doses, usually up to 3600 µg/plate for non-toxic and soluble compounds, were tested in all 5 strains with and without activation by the S9 liver fraction from Aroclor-pretreated rats.

Vehicle / solvent:

All compounds were tested on 2 slightly different minimal media: one (in the following named ZLM medium) is a modified minimal medium for E. coli, and the other is the Vogel-Bonner (VB) medium. ZLM medium contained (in g/l): tri-Na-citrate 2H2O (0.82), K2HP04 3H20 (4.60), KH2PO4 (1.50), (NH4)2SO4 (1.00), MgSO4 7H2O (0.10) and glucose (17.0). The concentration of citrate was 3.5 times higher in VB medium than in ZLM medium. The concentrations of the other ions are up to 2-fold higher in VB medium.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other:

Metabolic activation:

with and without

Genotoxicity:

negative

Applicant's summary and conclusion

Conclusions:

Sodium hexafluorosilicate showed negative results in the Ames test (with and without S9 activation).