Registration Dossier
Registration Dossier
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EC number: 913-660-8 | CAS number: -
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:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of glycerol and N-[3-(dimethylamino)propyl]stearamide and N-[3-(dimethylamino)propyl]docosanamide
- Molecular formula:
- C21 H50 N O C23 H54 N O C25 H58 N O C27 H62 N O
- IUPAC Name:
- Reaction mass of glycerol and N-[3-(dimethylamino)propyl]stearamide and N-[3-(dimethylamino)propyl]docosanamide
- Test material form:
- solid: flakes
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Remarks:
- 97a
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 activation system
- Test concentrations with justification for top dose:
- 0.16mg per plate top dose showing signs of toxicity in the assay
0.05mg per plate
0.016mg per plate
0.005mg per plate
concentration based on OECD 471 recommendations - Vehicle / solvent:
- Ethanol
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- sodium azide
- mitomycin C
- other: 4-nitro-0-phenylene-diamine (NPD)
- Details on test system and experimental conditions:
- see report
- Rationale for test conditions:
- see report
- Evaluation criteria:
- see report
- Statistics:
- see report
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 97
- Remarks:
- 97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- see report
Applicant's summary and conclusion
- Conclusions:
- non mutagenic
- Executive summary:
The test sample concentrations did not produce a two-fold increase in the number of revertants or produce a clear dose related response in any of the 5 tester strains. The sport tests showed a clear zone at the inoculation site indicating that the highest concentration tested was cyto-toxic and could kill the bacteria cell. The spots plates did not show a zone of increased reversion at the inoculation site indicating the sample was not mutagenic in the strains. In summary the sample concentrations tested against the five strains did not meet the the criteria for a potential mutagen.
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