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EC number: 816-324-8 | CAS number: 2044770-20-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,1'-[(3-{bis[3-(dimethylamino)propyl]amino}propyl)imino]dipropan-2-ol
- EC Number:
- 816-324-8
- Cas Number:
- 2044770-20-7
- Molecular formula:
- C19H44N4O2
- IUPAC Name:
- 1,1'-[(3-{bis[3-(dimethylamino)propyl]amino}propyl)imino]dipropan-2-ol
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- Histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Post-mitochondrial fraction (S9 fraction) from rats treated with Aroclor 1254, prepared according to MARON and AMES (1983) was obtained from Trinova Biochem8. S9 was collected from male rats.
- Test concentrations with justification for top dose:
- Strains:
5 strains of Salmonella typhimurium (TA98, TA100, TA102, TA1535, TA1537)
Concentrations: 31.6, 100, 316, 1000, 3160 and 5000 μg test item per plate
Plates:
3 per concentration and experiment
Experiments:
2 independent experiments, each with and without metabolic activation
Justification for top dose:
The test item (PU-2017-766) was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA100. Ten concentrations ranging from 0.316 to 5000 μg/plate were tested. Cytotoxicity (scarce background lawn and reduction of the number of revertants by more than 50%) was noted starting at the top concentration of 5000 μg PU-2017-766/plate in both experiments (see tables 1 and 2).
Hence, 5000 μg PU-2017-766 per plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test. - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-aminoanthracene
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, under the present test conditions, the test item tested up to a concentration of 5000 µg/plate (cytotoxic in the preincubation test) caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
- Executive summary:
In conclusion, under the present test conditions, the test item tested up to a concentration of 5000 µg/plate (cytotoxic in the preincubation test) caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
Cytotoxicity:
No signs of cytotoxicity were noted in the plate incorporation test without and with metabolic activation up to the top concentration of 5000 μg the test item//plate in any test strain. Cytotoxicity (scarce background lawn and reduction of the number of revertants) was noted in the preincubation test without and with metabolic activation at the top concentration of 5000 μg/plate in all test strains and, in addition, at 3160 μg/plate in test strains TA100 and TA102.
Mutagenicity:
No increase in revertant colony numbers as compared with control counts was observed for the test item, tested up to a concentration of 5000 μg/plate (cytotoxic in the preincubation test), in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation test and preincubation test).
The positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.
The results of the negative and positive control cultures are within the range of the historical data generated by the examining laboratory.
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