Registration Dossier
Registration Dossier
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EC number: 600-026-8 | CAS number: 1000817-22-0
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide
- EC Number:
- 600-026-8
- Cas Number:
- 1000817-22-0
- Molecular formula:
- Unspecified
- IUPAC Name:
- Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide
- Details on test material:
- Name of the test substance: Kerocom FM 38
Batch No.: 2008250
Constituent 1
Method
- Target gene:
- S. typhimurium and E. coli
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S-9 fraction
- Test concentrations with justification for top dose:
- 20 ug - 5 000 ug/plate (standard plate test)
15.6 ug - 250 ug/plate (preincubation test; TA 1535, TA 100, TA 1537 without S9 mix)
31.3 ug - 500 ug/plate (preincubation test; TA 1535, TA 100, TA 1537 with S9 mix)
31.3 ug - 500 ug/plate (preincubation test; TA 98 with and without S9 mix)
20 ug - 5000 ug/plate (PIT; E. coli WP2 uvrA with and without S9 mix) - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: with S9 mix: 2-aminoanthracene; without S9 mix: N-melhyl-N'-nitro-N-nitrosoguanidine; 4-nitro-o-phenylenediamine, 9-aminoacridine and 4-nitroquinoline-N-oxide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. about
doubling of the spontaneous mutation rate in at least one tester strain either without
S9 mix or after adding a metabolizing system.
A test substance is generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the historical negative control
range under all experimental conditions in at least two experiments carried out
independently of each other. - Statistics:
- not applicable
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- A bacteriotoxic effect was observed depending on the strain and test conditions from about 125 ug/plate onward using Salmonella strains.
- Cytotoxicity / choice of top concentrations:
- other:
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Remarks:
- bacteriotoxicity was occasionally observed from 2 500 ug/plate onward
- Cytotoxicity / choice of top concentrations:
- other:
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system.
- 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
According to the results of the present study, the test substance Keracom FM 38 is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions chosen here.
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