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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 guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
adopted July 1997
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Version / remarks:
adopted May 2008
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
Version / remarks:
adopted Aug. 1998
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines
EC Number:
614-682-8
Cas Number:
68647-95-0
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines
Details on test material:
- Name of test material (as cited in study report): Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines
- Physical state: amber liquid
- Analytical purity: The test item is a complex mixture of isomers and homologue components, so no purity can be stated (For details see analytical report BASF study-No.: 11S05363)
- Purity test date: 2012-08-08
- Lot/batch No.: BI514173
- Expiration date of the lot/batch: 2013-04-18
- Storage condition of test material: room temperature

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Details on mammalian cell type (if applicable):
The Salmonella strains are checked for the following characteristics at regular intervals: deep rough character (rfa); UV sensitivity (Δ uvrB); ampicillin resistance (R factor plasmid). E. coli WP2 uvrA is checked for UV sensitivity.
Metabolic activation:
with and without
Metabolic activation system:
phenobarbital / β-naphthoflavone induced rat liver S9
Test concentrations with justification for top dose:
33, 100, 333, 1000, 2500, 5000µg/plate (standard test)
3.3, 10, 33, 100, 333, 1000µg/plate (preincubation assay)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: solubility of the test substance and availability of historical control data
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
no
Positive control substance:
other: 2-aminoanthracene
Remarks:
with S9
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: N-methyl-N'-nitro-N-nitrosoguanidine (TA 1535, TA 100), 4-nitro-o-phenylenediamine (TA 98), 9-aminoacridine (TA 1537), 4-nitroquinoline-N-oxide (e.coli)
Remarks:
without S9
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation, standard plate test) or preincubation in suspension;
DURATION
- Preincubation period: 20min (pre-incubation assay)
- Exposure duration: 48 - 72h

SELECTION AGENT (mutation assays): trp or his depleted agar

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertants, reduced background growth, reduced titer
Evaluation criteria:
Acceptance criteria
• The number of revertant colonies in the negative controls is within the range of the historical negative control data for each tester strain.
• The sterility controls revealed no indication of bacterial contamination.
• The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above.
• Fresh bacterial culture containing approximately 10^9 cells per mL were used. For approval the titer of viable bacteria was ≥ 10^8 colonies per mL.

Assessment criteria
The test substance is considered positive in this assay if a dose-related and reproducible increase in the number of revertant colonies is observed, 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 are within the historical negative control
range under all experimental conditions in at least two experiments carried out independently of each other.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 1000µg/plate in the standard plate assay, and >=333µg/plate in the pre-incubation assay depending on the strain
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation observed
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

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