Silicic acid, aluminum magnesium sodium salt

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

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

Justification for type of information:

Test material ist different from reference substance but comparable, see chapter 13, attachment 'Analogue Approach Justification'

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The host organism is inoculated by intraperitoneal injection with a common indicator microorganism/tester strain before treatment with the test substance. After "incubation" in the host organism, the tester strain is withdrawn from the ascites and tested for mutation on minimal agar plate., e.g. accroding to Ames.

GLP compliance:

not specified

Type of assay:

other: host mediated assy

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, aluminum sodium salt

EC Number:

215-684-8

EC Name:

Silicic acid, aluminum sodium salt

Cas Number:

1344-00-9

Molecular formula:

AlNaO6Si2

IUPAC Name:

aluminium(3+) sodium bis(oxosilanebis(olate))

Details on test material:

Other Test Substance
SIPERNAT 820A, sodium aluminium silicate (Degussa) [CAS No. 1344-00-9]
Chemical formula: 1.2Na2O x Al2O3 x 13.4SiO2
Degree of Purity: ~99 %
Water solubility: 48 mg/L

Specific details on test material used for the study:

FDA-Compound 71-45, "sodium silicoaluminate",
synthetic silica
Lot no. SR-1621

Test animals

Species:

mouse

Strain:

ICL-ICR

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Details on exposure:

Type: Salmonella typhimurium reverse mutation assay
Method: The test substance was administered orally to 10 host animals per dose. In the acute study the bacteria (Salmonella typhimurium TA 1530 and his G-46)were inocculated i.p. after the administration of the test substance. In the subacute study the bacteria were injected after the last administration of the test substance. Negative (0.85 % saline) and positive (100 mg/kg dimethylnitrosamine) controls were run in parallel. The animals were sacrificed three hours after administration and the bacteria were removed from the peritoneal cavity. The induction of reverse mutation was quantified on agar plates. 

Duration of treatment / exposure:

single administration ("acute") and repeated administration (5 times, "subacute")

Frequency of treatment:

1x and 5x (1x/d)

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

4.25 mg/kg bw/day (nominal)

Remarks:

suspended in 0.85 % saline, administered 1x/d (Test I)

Doses / concentrations 2

Dose / conc.:

42.5 mg/kg bw/day (nominal)

Remarks:

suspended in 0.85 % saline, administered 1x/d (Test I)

Doses / concentrations 3

Dose / conc.:

425 mg/kg bw/day (nominal)

Remarks:

suspended in 0.85 % saline, administered 1x/d (Test I)

Doses / concentrations 4

Dose / conc.:

5 000 mg/kg bw (total dose)

Remarks:

suspended in 0.85 % saline (Test II)

No. of animals per sex per dose:

10 (males only)

Control animals:

yes, concurrent vehicle

Positive control(s):

yes, treated with 100 mg/kg bw Dimethylnitrosamine (DMN)

Results and discussion

Test results

Key result

Sex:

male

Genotoxicity:

negative

Toxicity:

not examined

Positive controls validity:

valid

Additional information on results:

There was a high increase in mutants following oral treatment with Dimethylnitrosamine (DMN), but no significant increases in mutation rates at any dose and dose regimen.

Applicant's summary and conclusion

Conclusions:

There was a high increase in mutants following oral treatment with DMN, but no significant increases in mutation rates at any dose and dose regimen.