Silicic acid, aluminum sodium salt

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: gene mutation

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

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 After "incubation" in the host organism, the tester strain is withdrawn from the ascites and tested for mutation on minimal agar plate., e.g. according to Ames.

GLP compliance:

no

Type of assay:

other: Host mediated assay

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:

nSiO2*mAl2O3*zNa2O n = 2-4; m = 0.12-3.20; z = 0.11-4.5

IUPAC Name:

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

Test material form:

solid: nanoform, no surface treatment

Remarks:

crystalline-free

Specific details on test material used for the study:

FDA-Compound 71-45, "sodium silicoaluminate", synthetic silica, Lot no. SR-1621, from the study report it cannot be ascertained wether a crystalline or amorphous form was used

Test animals

Species:

mouse

Strain:

ICR

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

saline

Duration of treatment / exposure:

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

Frequency of treatment:

1x and 5x (1x/d)

Doses / concentrations

Remarks:

Doses / Concentrations:
4.25, 42.5 and 425 mg/kg bw, suspended in 0.85 % saline, administered 1x/d (Test I), 5000 mg/kg bw (Test II)
Basis:

Control animals:

yes, concurrent vehicle

Positive control(s):

Ethyl Methane Sulfonate: 350 mg/kg bw
Dimethyl Nitrosamine: 100 mg/kg bw

Results and discussion

Test results

Key result

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

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.