Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sept. - Oct. 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
certified by Landesamt für Umwelt, wasserwirtschaft und Gewerbeaufsicht Rheinland-Pfalz, Kaiser Friedrich Str. 7, 55116 Mainz, Germany
Type of assay:
bacterial reverse mutation assay

Test material

1
Chemical structure
Reference substance name:
Triethoxypropylsilane
EC Number:
219-842-7
EC Name:
Triethoxypropylsilane
Cas Number:
2550-02-9
Molecular formula:
C9H22O3Si
IUPAC Name:
triethoxy(propyl)silane

Method

Target gene:
hisD6610 (frame shift), hisD3052 (frame shift), hisG46 (base pair substitution), hisG428 (base pair substitution) causing histidine deficiency
uvrB (deletion) causing UV sensitivity and biotine defiency, rfa (deletion) causing lipopolysaccharide side chain defiency, pKM101 (plasmide) causing ampillicine resistance, pAQ1 (plasmide) causing tetracycline resistance
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium, other: TA97a
Additional strain / cell type characteristics:
other: Mutations: hisD6610, uvrB, rfa, pKM101
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
other: Mutations: hisD3052, uvrB, rfa, pKM101
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
other: Mutations: hisG46, uvrB, rfa, pKM101
Species / strain / cell type:
S. typhimurium TA 102
Additional strain / cell type characteristics:
other: Mutations: hisG428, rfa, pKM101, pAQ1
Species / strain / cell type:
S. typhimurium TA 1535
Additional strain / cell type characteristics:
other: Mutations: hisG46, uvrB, rfa
Metabolic activation:
with and without
Metabolic activation system:
S9-mix (rat liver)
Test concentrations with justification for top dose:
first experiment: 5 concentrations: 1500/500/150/50/15 µg/plate (plate incorporation method)
second experiment: 6 different concentrations:1500/750/375/188/94/47 µg/plate (pre-incubation method)
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
4-nitro-1,2-phenylene Diamine and Sodium azide without metabolic activation, 2-Amino-Anthracene and Benzo-a-Pyrene with metabolic activation
Details on test system and experimental conditions:
First experiment: plate incorporation method, 1500-15µg/plate, 48h, 37°C, with and without S9-mix, 3 plates per strain and dose
Second experiment: pre-incubation method, 1500-47µg/plate, 48h, 37°C, with and without S9-mix, 3 plates per strain and dose
For the solvent control (with and without S9-mix) and the positive controls, 4 plates were used
Genotype Confirmation, toxicity control and sterility controls were performed
Rationale for test conditions:
Guideline
Evaluation criteria:
The colonies were counted visually, the numbers were recorded. An increase of revertant colonies iper plate in at least one strain or a concentration related increase over the range tested can be taken as a sign of mutagenicity.
Statistics:
mean values, standard deviations, increase factors (mean revertants divided by mean spontaneous revertants)

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium, other: all tested strains (TA97a, TA98, TA100, TA102, TA1535)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Valid test according Guideline 471. No mutagenic potential found in this test.