Registration Dossier
Registration Dossier
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EC number: 700-404-3 | CAS number: 127929-37-7
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:
- 2009
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
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:
- 2,2-bis({[3-(4-ethylpiperazin-1-yl)propanoyl]oxy}methyl)butyl 3-(4-ethylpiperazin-1-yl)propanoate
- EC Number:
- 700-404-3
- Cas Number:
- 127929-37-7
- Molecular formula:
- C33H62N6O6
- IUPAC Name:
- 2,2-bis({[3-(4-ethylpiperazin-1-yl)propanoyl]oxy}methyl)butyl 3-(4-ethylpiperazin-1-yl)propanoate
Constituent 1
Method
- Target gene:
- Salmonella typhimurium LT2
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, rfa
- Species / strain / cell type:
- S. typhimurium, other: TA97a
- Additional strain / cell type characteristics:
- other: hisD6610,uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: hisD3052, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: hisG428, pKM 101, rfa
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- The test item was dissolved in dimethyl sulfoxide (DMSO). The stock solution containing 50g/L was prepared.
First experiment (plate incorporation method): test concentrations: 5020 / 1506 / 502 / 151 / 50 µg/plate
Second experiment (pre-incubation method): test concentrations: 5051 /2526 / 1263 µg/plate - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- H2O, DMSO
- True negative controls:
- other: comparison with historical data
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- strain 98, with metabolic activation system
Migrated to IUCLID6: concentration per plate: 40 µg
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- H2O, DMSO
- True negative controls:
- other: comparison with historical data
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (1-AA), 3 µg per plate
- Remarks:
- strains 97a, 100, 102, 1535, with metabolic activation system
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- H2O, DMSO
- True negative controls:
- other: comparison with historical data
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine, 80 µg per plate
- Remarks:
- strains 97 a, 98, 102, without metabolic activation system
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- H2O, DMSO
- True negative controls:
- other: comparison with historical data
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- strains 100, 1535, without metabolic activation system
Migrated to IUCLID6: concentration per plate: 6 µg
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- 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
- Species / strain:
- S. typhimurium, other: TA 97a
- 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
- Species / strain:
- S. typhimurium TA 98
- 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
- Species / strain:
- S. typhimurium TA 100
- 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
- Species / strain:
- S. typhimurium TA 102
- 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'.
Any other information on results incl. tables
All results including tables and figures are given in the attached full study report.
Applicant's summary and conclusion
- Conclusions:
- The test item B 1061 did not show mutagenic effects in both experiments. The number of revertant colonies was not increased in comparison with
the spontaneous revertants (solvent only). Cytotoxicity of the test item was not detected. The background lawn was visible and the number of rever- tants was not significantly decreased.
Therefore it can be stated, that under the test conditions, the test item B 1061 is not mutagenic in the Bacterial Reverse Mutation Test using
Salmonella typhimurium, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535. - Executive summary:
Two valid experiments were performed.
First experiment: Five concentrations of the test item B 1061, dissolved in DMSO (ranging from 5020 to 50 µg/plate) were used. Five genetically manipulated strains of Salmonella typhimurium (TA 97a, TA 98, TA 100, TA 102, TA 1535) were exposed to the test item both in the presence and in the absence of a metabolic activation system (S9) for 48 hours, using the plate incorporation method.
None of the concentrations caused a significant increase in the number of revertant colonies in the tested strains. The test item didn't show any mutagenic effects in the first experiment.
No signs of toxicity towards the bacteria could be observed.
The sterility control and the determination of the titre didn't show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range. All positive controls showed mutagenic effects with and without metabolic activation.
Second experiment: To verify the results of the first experiment, a second experiment was performed, using three concentrations of the test item (ranging from 5051 to 1263 µg/plate) and a modification in study performance (pre-incubation method).
The test item B 1061 didn't show mutagenic effects in the second experiment, either.
No signs of toxicity towards the bacteria could be observed.
The sterility control and the determination of the titre didn't show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range. All positive controls showed mutagenic effects with and without metabolic activation.
Under the conditions of the test, the test item B 1061 didn't show mutagenic effects towards Salmonella typhimurium, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535. Therefore, no concentration-effect relationship could be determined.
The test item B 1061 is considered as "not mutagenic under the conditions of the test".
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