Zeolite, cuboidal, crystalline, synthetic, non-fibrous

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

A structural analogue substance was used for assessment since the performed study is well documented, according to current guidelines and GLP compliant. The "Structural Analogues Substances Approach" is provided in chapter 13.2.

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 followed

Principles of method if other than guideline:

Cytogenetic study to determe chromosomal damage: This is accomplished
by observing cells in anaphase. As the chromatids separate and move along the spindle, aberrations may occur.

GLP compliance:

not specified

Type of assay:

in vitro mammalian chromosome aberration test

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:

Silicic acid, aluminium sodium salt

Test material form:

solid: nanoform, no surface treatment

Specific details on test material used for the study:

Sodium aluminosilicate (Compound FDA 71-45, Synthetic Silica, Lot Number SR-1621, as supplied by the Food and Drug Administration)

Method

Species / strain

Species / strain / cell type:

mammalian cell line, other: human embryonic lung cultures (WI-38)

Metabolic activation:

without

Test concentrations with justification for top dose:

1, 10, 100 µg/ml

Vehicle / solvent:

saline

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

triethylenemelamine

Results and discussion

Test results

Key result

Species / strain:

mammalian cell line, other: human embryonic lung cultures (WI-38)

Metabolic activation:

without

Genotoxicity:

not determined

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The negative controls, medium level and low level tested exhibited 2, 0, and 1 percent acentric fragments, respectively. The high level had one cell with an acentric fragment and one cell with a bridge. This was not considered significant. The positive controls contained four cells with pulverization together with other aberrations.

Applicant's summary and conclusion

Conclusions:

The compound produced no significant aberration in the anaphase chromosomes of human tissue culture cells when tested at the dosage levels employed in this study.

Executive summary:

This study investigated into the potential of Sodium aluminosilicate to produce cytotoxicity in human embryonic lung cultures (WI-38). No significant changes to the control were observed.