Zeolite, cuboidal, crystalline, synthetic, non fibrous, thermally produced

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. Detailed report available.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Reference 2

Reference Type:

publication

Title:

Bacterial mutagenicity testing of 49 food ingredients gives very few positive results

Author:

Prival MJ, Simmon VF and Mortelmans KE

Year:

1991

Bibliographic source:

Mutat. Res. 260, 321-329

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Plate Incorporation Assay

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

- Name of test material (as cited in study report): Sodium aluminium silicate, compound F76-001
- Chemical name: Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- Framework: cuboidal
- Related CAS number: 1318-02-1
- Analytical purity: no data

Method

Target gene:

his operon

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium (TA98, TA100, TA1535, TA1537, TA1538), and E. coli WP2 (uvrA)

Metabolic activation:

with and without

Metabolic activation system:

S9-mix contained 10% Aroclor 1254-induced liver S9 from male Sprague Dawley rats

Test concentrations with justification for top dose:

0.0003, 0.0033, 0.033, 0.1, 0.33, 1.0, 3.3, or 10 mg/plate (suspended in 0.067 M potassium phosphate buffer)

Vehicle / solvent:

- solvent: 0.067 M potassium phosphate buffer (pH 7.0)
- the test substance did not dissolve completely in the solvent and was tested as a precipitate

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

0.067 M potassium phosphate buffer

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: - 2-nitrofluorene (5.0 µg/plate) for TA98 and TA1538 - 2-Anthramine (1 or 2.5 µg/plate) for TA98, TA100, TA1535, TA1538 TA1537, and E. coli WP2 - sodium azide (1 or 0.5 µg/plate) for TA100 and TA1535 - 9-aminoacridine (50 or 100 µg/plate) for TA1537 - AF2

Details on test system and experimental conditions:

Plate Incorporation Assay:
- Metabolic activation system: S9-mix contained 10% Aroclor 1254-induced liver S9 from male Sprague Dawley rats.
- 0.05 mL indicator organism with or without S9-mix

Positive and negative control groups and treatment:
positive control compounds without S9-mix:
--------------------------------------------
- 2-nitrofluorene (5.0 µg/plate) for TA98 and TA1538
- 2-Anthramine (1 or 2.5 µg/plate) for TA98, TA100, TA1535, TA1538 TA1537, and E. coli WP2
- sodium azide (1 or 0.5 µg/plate) for TA100 and TA1535
- 9-aminoacridine (50 or 100 µg/plate) for TA1537
- AF2 for E. coli WP2

positive control compounds with S9-mix:
-----------------------------------------
- 2-Anthramine (1 or 2.5 µg/plate) for TA98, TA100, TA1537, TA1538, TA1535, and E. coli WP2

Compound F76-001 was tested in the form of a precipitate in all of the assays performed.
Compound F76-001 was first tested in a range finding assay of ten doses between 0.3 and 10,000 ug/plate with TA 100.

Results and discussion

Test results

Species / strain:

other: TA98, TA100, TA1535, TA1537, TA1538), and E. coli WP2 (uvrA)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

The range finding test was performed with TA100. At a dose of 10,000 µg/plate without metabolic activation, the number of histidine-independent revertants was more than twice then that for the control. The compound was tested again at the three highest doses of the range finding tests in further assays. No mutagenicity was observed in all test strains at any concentration tested. A precipitation from the compound could be seen on the plates at the higher dose 1000 to 10,000 µg/plate.
Compound F76-001 (zeolite A) did not appear to be mutagenic or toxic in these assays.
The positive controls gave appropriate responses.

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