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Toxicological information

Genetic toxicity: in vitro

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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:
2009
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

Constituent 1
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

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.