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EC number: 307-037-4 | CAS number: 97488-98-7
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
- Study period:
- March 18 - April 23 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD 471, EC B.13/14)
- Justification for data waiving:
- other:
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: unspecified EPA OPPTS harmonised guidelines
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Oils, fish, oxidized, bisulfited, sodium salts
- EC Number:
- 307-037-4
- EC Name:
- Oils, fish, oxidized, bisulfited, sodium salts
- Cas Number:
- 97488-98-7
- Molecular formula:
- Not applicable
- IUPAC Name:
- not available
- Details on test material:
- - Name of test material (as cited in study report): FLL sample 3
- Chemical name: Oils, fish, oxidized, bisulfited, sodium salts (triglycerides, C12 to C24, even, saturated and unsaturated, bisulfited, sodium salt)
- Physical state: viscous liquid
- Purity: 90%
- Impurities: 10% water content by Karl Fischer
- Lot/batch No.: LS06921
- Expiration date of the lot/batch: 13 October 2010
- Storage condition of test material: room temperature in the dark
- Other: amber color
- All other template details: Not reported
Constituent 1
Method
- Target gene:
- histidine in Salmonella strains and tryptophan in E. coli
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: uvrB-, and pKM101
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- in µg/plate: 0, 50, 150, 500, 1500, 5000
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: tetrahydrofuran
- Justification for choice of solvent/vehicle: test material was immiscible in sterile distilled water, dimethyl sulphoxide, acetone, dimethyl formamide and acetonitrile
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- vehicle and positive controls used without S9-mix, negative controls used with S9-mix
Migrated to IUCLID6: (, also 9-aminoacridine and 4-nitroquinoline-1-oxide)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
- All other template details: Not reported
SELECTION AGENT (mutation assays): not reported
NUMBER OF REPLICATIONS: three
NUMBER OF CELLS EVALUATED: 0.1 ml of bacterial culture, in the range of 1-9.9 x 10^9 bacteria per ml
DETERMINATION OF CYTOTOXICITY
- Method: growth, numbers of revertant colonies
OTHER EXAMINATIONS: Not reported - Evaluation criteria:
- There are several criteria for determining a positive result, such as a dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. Biological relevance of the results will be considered first, statistical methods, as recommended by the UKEMS can also be used to aid evaluation, however, statistical significance will not be the only determining factor for a positive response.
- Statistics:
- Not reported
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
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- growth of background bacterail lawn
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- growth of background bacterail lawn
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS:
- Precipitate: an opaque film was noted on the 5000 µg/plate tests
- All other template details: none reported
RANGE-FINDING/SCREENING STUDIES: concentrations tested ranged from 0.15 to 5000 µg/plate, and after 48 hours was determined to be non-toxic to the strains of bacteria used.
COMPARISON WITH HISTORICAL CONTROL DATA: vehicle and positive control data presented in Tables below
ADDITIONAL INFORMATION ON CYTOTOXICITY: not reported - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Mean (and standard deviation of 3 replicates) numbers of revertant colonies without metabolic activation.
Table 2. Mean (and standard deviation of 3 replicates) numbers of revertant colonies with metabolic activation
Table 3. Mean (and standard deviation of 3 replicates) numbers of revertant colonies without metabolic activation after 20 minutes of pre-incubation with the test substance.
Table 4. Mean (and standard deviation of 3 replicates) numbers of revertant colonies with metabolic activation after 20 minutes of pre-incubation with the test substance.
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
This substance is considered to be non-mutagenic under the conditions of this test. - Executive summary:
Study Summary:
Introduction: This method conforms to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Agencies including METI, MHLW and MAFF. It also meets the requirements of the OECD Guidelines for Testing of Chemicals No. 471 “Bacterial Reverse Mutation Test”, Method B13/14 of Commission Regulation (EC) Number 440/2008 of 30 May 2008 and the USA, EPA (TSCA) OPPTS harmonized guidelines.
Methods. Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli strain WP2uvrA- were treated with the test material using both the Ames plate incorporation and pre-incubation methods at five dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolizing system (10% liver S9 in standard co-factors). The dose range was determined in a preliminary toxicity assay and was 50 to 5000µg/plate in the first experiment. The experiment was repeated on a separate day (pre-incubation method) using the same dose range as Experiment 1, fresh cultures of the bacterial strains and fresh test material formulations.
Results. The vehicle (tetrahydrofuran) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S-9 mix were validated.
The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level and was, therefore tested up to the maximum recommended dose level of 5000µg/plate. An opaque film was noted at 5000µg/plate, this observation did not prevent the scoring of revertant colonies.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation or exposure method.
Conclusion. The test material was considered to be non-mutagenic under the conditions of this test.
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