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EC number: 609-051-9 | CAS number: 35000-37-4
Toxicological information
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14.01.2008 to 03.03.2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [2-(tert-butoxy)-2-oxoethyl]triphenylphosphanium chloride
- EC Number:
- 609-051-9
- Cas Number:
- 35000-37-4
- Molecular formula:
- C24H26ClO2P
- IUPAC Name:
- [2-(tert-butoxy)-2-oxoethyl]triphenylphosphanium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- The characteristics of the different Salmonella typhimurium strains were as follows:
Strain Histidine mutation Mutation type
TA 1537 hisC3076 Frameshift
TA 98 hisD3052/R-factor* Frameshift
TA 1535 hisG46 Base-pair substitutions
TA 100 hisG46/R-factor* Base-pair substitutions
*: R-factor = plasmid pKM101 (increases error-prone DNA repair)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- In the dose range finding test, DCM was tested up to concentrations of 5000 IJg/plate in the absence and presence of 5% (v/v) 89-mix
in the strains TA100 and WP2uvrA. DCM did not precipitate on the plates at this dose level. The bacterial background lawn was not reduced at
any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed. Results of this dose range finding
test were reported as part of the first experiment of the mutation assay.
Based on the results of the dose range finding test, DCM was tested in the first mutation assay at a concentration range of 1 00 to 5000 µg/plate
in the absence and presence of 5% (v/v) S9-mix in tester strains TA1535, TA1537 and TA98. The bacterial background lawn was not
reduced at any of the concentrations tested and no biologically relevant decrease in the number
of revertants was observed.
In an independent repeat of the assay with additional parameters, DCM was tested at the same concentration range as the first assay
in the absence and presence of 10% (v/v) S9-mix in tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA. Toxicity was only
observed in tester strains TA1537 and TA100 in the presence of S9-mix.
Since more severe toxicity was observed in tester strain TA1537 and TA100 in the presence of 10% (v/v) S9-mix in comparison with the
other strains, a third mutation experiment was performed with these strains in the presence of 1 0% (v/v) S9-mix. DCM was tested at a
concentration range of 100 to 5000 µg/plate. Toxicity was again observed in both tester strains.
DCM did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains
(TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence
of S9-metabolic activation. These results were confirmed in independently repeated experiments.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Saline
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5 µg/plate
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535 without metabolic activation (-S9 mix)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Milli-Q water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 60 µg/plate
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 without metabolic activation (-S9 mix)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 10 µg/plate
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 without metabolic activation (-S9 mix)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 650 µg/plate
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 100 without metabolic activation (-S9 mix)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 10 µg/plate
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- WP2uvrA without metabolic activation (-S9 mix)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 1 µg/plate
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 1535 with metabolic activation (+S9 mix)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2.5 µg/plate and 5 µg/plate
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 1537 with metabolic activation (+S9 mix)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 1 µg/plate
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 98 with metabolic activation (+S9 mix)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 1 µg/plate and 2.5 µg/plate
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 100 with metabolic activation (+S9 mix)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 10 µg/plate
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- WP2uvrA with metabolic activation (+S9 mix)
- Details on test system and experimental conditions:
- Test system: Salmonella typhimurium bacteria and Escherichia coli bacteria
Rationale: Recommended test system in international guidelines (e.g. OECD, EEC).
Source:
Salmonella typhimurium strains:
Trinova Biochem GmbH, Germany (Master culture from Dr. Bruce N. Ames):
TA100 received on 14-06-2006, used batch: TA100.210807
TA98 received on 14-06-2006, used batch: TA98.210807
TA1537 received on 14-06-2006, used batch: TA1537.210807
TA1535 received on 14-06-2006, used batch: TA1535.210807
Escherichia coli strain:
Trinova Biochem GmbH, Germany (Master culture from The National
Collections of Industrial and Marine Bacteria, Aberdeen, UK)
WP2uvrA received on 14-06-2006, used batch: EC.0'70307
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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 with metabolic activation
negative without metabolic activation
All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of
revertants in two independently repeated experiments.
The negative and strain-specific positive control values were within our laboratory historical control data ranges indicating that
the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that DCM is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the
Escherichia coli reverse mutation assay.
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