Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979
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:
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium aluminium silicate, compound F76-001
- 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