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Toxicological information

Genetic toxicity: in vitro

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Administrative data

in vitro gene mutation study in bacteria
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sep 05 - Oct 28, 2008
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD TG 471.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Fluorphlogopite (Mg3K[AlF2O(SiO3)3])
EC Number:
EC Name:
Fluorphlogopite (Mg3K[AlF2O(SiO3)3])
Cas Number:
Molecular formula:


Target gene:
HIS operon
TRP operon
Species / strain
Species / strain / cell type:
bacteria, other: S. typhimurium TA 98, TA 100, TA 102, TA 1535, TA 1537, and E. coli WP2 uvrA
Metabolic activation:
with and without
Metabolic activation system:
S9 mix from liver of Aroclor induced rats
Test concentrations with justification for top dose:
1st series: 5.00, 15.8, 50.0, 158, 500, 1580 and 5000 µg per plate
2nd series: 0.500, 1.58, 5.00, 15.8 and 50.0 µg per plate
Vehicle / solvent:
ultrapure water
Untreated negative controls:
Negative solvent / vehicle controls:
Positive controls:
Positive control substance:
other: daunomycin, sodium azide, 9-aminoacridine, 4-nitroquinolin-N-oxide, cumene hydroperoxide, 2-aminoanthracene and benzo[a]pyrene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

- incubation period: 2-3 days
- Exposure duration: 2-3 days

SELECTION AGENT (mutation assays): Histidine


- Method: other: background toxicity

Evaluation criteria:
A test material is defined as non-mutagenic in this assay if
• "no" or "weak increases" occur in the first and second series of the main experiment. ("Weak increases" randomly occur due to experimental variation.)

A test material is defined as mutagenic in this assay if
• a dose-related (over at least two test material concentrations) increase in the number of revertants is induced, the maximal effect is a "clear increase", and the effects are reproduced at similar concentration levels in the same test system;
• "clear increases" occur at least at one test material concentration, higher concentrations show strong precipitation or cytotoxicity, and the effects are reproduced at the same concentration level in the same test system.
In all further cases, a third test series with the bacterial strain in question should be performed and the results of each series be discussed case by case.


Results and discussion

Test results
Species / strain:
bacteria, other: S. typhimurium TA 98, TA 100, TA 102, TA 1535, TA 1537, and E. coli WP2 uvrA
Metabolic activation:
with and without
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
Untreated negative controls validity:
Positive controls validity:
Additional information on results:
- Precipitation: at concentration larger than 50 µg/plate
Remarks on result:
other: all strains/cell types tested
Migrated from field 'Test system'.

Applicant's summary and conclusion

Interpretation of results (migrated information):

The test material was not mutagenic under the described experimental conditions.
Executive summary:


Study design

The investigations for the mutagenic potential of the test material were performed using Salmonella typhimurium TA 100, TA 98, TA 102, TA 1535, TA 1537, and  Escherichia coli WP2 uvrA as tester strains. The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pretreated rats was used. Two independent experimental series were performed.


The test test was perfomred at concentrations ranging from 5.00 to 5000 µg/plate. Precipitation of the test material on the agar plates did occur at concentraions larger than 50 µg/plate. Toxicity to the bacteria was not observed.
9-Aminoacridine, daunomycin, 1-ethyl-2-nitro-3  nitrosoguanidine, methyl methanesulfonate, 4-nitrofluorene, 4-nitro-1,2-phenylenediamine, and sodium azide served as strain specific positive control test materials in the absence of S9 mix. 2-Aminoanthracene was used for testing the bacteria and the activity of the S9 mix. Each treatment with the test materials used as positive controls led to a clear increase in revertant colonies, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used.
The validity of the mutation assay can be assessed by the results obtained for the positive and negative controls. The negative control mutant frequencies were all in the regular range, and the positive control compounds yielded the expected mutant frequencies that were greatly in excess of the background.
The results of the experiments conducted on the test material in the absence and presence of a metabolic system were negative. The second experiments were also negative. The test material is not mutagenic in Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538, and Escherichia coli WP2, and WP2 uvrA.


With and without addition of S9 mix as the external metabolizing system, the test material was not mutagenic under the experimental conditions described.