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EC number: 701-326-2 | CAS number: -
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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:
- From 2008-08-20 to 2008-09-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 471 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Program (inspected on 21th August 2007 / Signed on 15th October 2007)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan
- EC Number:
- 229-861-2
- EC Name:
- [3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan
- Cas Number:
- 6790-58-5
- Molecular formula:
- C16H28O
- IUPAC Name:
- (3aR,5aS,9aS,9bR)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan
- Reference substance name:
- (3aS,5aR,9aR,9bS)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan
- Cas Number:
- 234431-64-2
- Molecular formula:
- C16H28O
- IUPAC Name:
- (3aS,5aR,9aR,9bS)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan
- Test material form:
- solid
- Details on test material:
- - Physical state: solid
- Stability under test conditions: at least 7 days when kept at room temperature.
- Storage condition of test material: In the refrigerator (2 - 8 °C), protected from light
- Molecular formula : C16 H28 O
- Molecular weight : 236.4 g/mol
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine gene for S. thyphimurium and tryptophan gene for E.coli
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):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from the livers of Sprague-Dawley rats treated with phenobarbitone/B-naphtoflavone
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate.
Range-finding test: 15, 50, 150, 500, 1500 and 5000 μg/plate for all S. strains; 50, 150, 500, 1500 and 5000 μg/plate for E. coli.
Main test: 50, 150, 500, 1500 and 5000 μg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: the test material was insoluble in water and dimethylsulphoxide at 50 mg/mL but was fully soluble in acetone at the same concentration in solubility checks performed in-house.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- See Table 7.2.1/1
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- See Table 7.2.1/1
- Positive control substance:
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Remarks:
- With S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: ca. 48 hours at 37°C
NUMBER OF REPLICATIONS: triplicate plates per dose level
DETERMINATION OF CYTOTOXICITY
- Method: growth assessment of the bacterial background lawn
OTHER EXAMINATIONS:
- Other: Observations of precipitate of the test substance
OTHER: ACCEPTANCE CRITERIA: The reverse mutation assay was considered valid if the following criteria were met:
1. All tester strain cultures exhibit a characteristic number of spontaneous revertants per plate in the vehicle and untreated controls (according to historical control 2006 & 2007).
2. The appropriate characteristics for each tester strain have been confirmed, eg rfa cell-wall mutation and pKM101 plasmid R-factor etc.
3. All tester strain cultures should be in the approximate range of 1 to 9.9 billion bacteria per mL.
4. Each mean positive control value should be at least two times the respective vehicle control value for each strain, thus demonstrating both the intrinsic sensitivity of the tester strains to mutagenic exposure and the integrity of the S9-mix.
5. There should be a minimum of four non-toxic test material dose levels.
6. There should be no evidence of excessive contamination. - Evaluation criteria:
- Dose-related increase in revertant frequency over the dose range tested and/or reproducible at one or more concentrations in at least one bacterial strain with or without metabolic activation.
A test material will be considered non-mutagenic (negative) in the test system if the above criteria are not met - Statistics:
- Statistical methods, as recommended by the UKEMS can be used as an aid to evaluation. However statistical significance will not be the only determining factor for a positive response.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not applicable
- Effects of osmolality: not applicable
- Evaporation from medium: the test material is not classified as a VOC.
- Water solubility: the test material was solubilised in acetone to improve solubility.
- Precipitation: A stringy, oily precipitate was observed at and above 1500 µg/plate, this did not prevent the scoring of revertants colonies.
- Other confounding effects: none
RANGE-FINDING/SCREENING STUDIES: the test material induced lowered revertant colony counts at the upper dose levels to TA100 but was non-toxic to WP2uvrA-. The test material formulation and S9-mix used in this experiment were both shown to be sterile. See table 7.6.1/2.
COMPARISON WITH HISTORICAL CONTROL DATA: All tester strain cultures exhibit a characteristic number of spontaneous revertants per plate in the vehicle and positive controls. The comparison was made with the historical control ranges for 2006 and 2007 of the corresponding Testing Laboratory.
ADDITIONAL INFORMATION ON CYTOTOXICITY: the test material caused no visible reduction in the growth of the bacterial background lawn at any dose level.
Any other information on results incl. tables
Table 7.6.1/2: Test results: Preliminary toxicity test
Metabolic activation |
Strain |
Dose (µ/plate) |
||||||||||
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
||
+ |
TA100 |
74 |
81 |
77 |
77 |
94 |
77 |
78 |
94 |
75 |
56 |
35 |
- |
64 |
64 |
70 |
66 |
85 |
72 |
62 |
63 |
65 |
36 |
20 |
|
+ |
WP2 uvrA- |
35 |
25 |
34 |
26 |
31 |
26 |
36 |
46 |
22 |
26 |
25 |
- |
30 |
35 |
31 |
34 |
28 |
25 |
34 |
32 |
41 |
26 |
22 |
Applicant's summary and conclusion
- Conclusions:
- ST 10 C 08 is not mutagenic with and without metabolic activation in S. thyphimurium strains TA1535, TA1537 TA98 & TA100, and E.coli WP2 uvrA-.
- Executive summary:
In a reverse gene mutation assay performed according to the OECD test guideline No. 471 and in compliance with GLP, S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and E.coli strain WP2 uvrA- were exposed to ST 10 C 08 diluted in acetone both in the presence and absence of metabolic activation system (10% liver S9 in standard co-factors) using the plate incorporation method. The dose range for the range-finding test was determined in a preliminary toxicity assay and ranged between 15 and 5000 µg/plate, depending on bacterial strain type. The experiment was repeated on a separate day using a modified dose range, 50 to 5000 µg/plate based on the results of the range-finding test.
The vehicle (acetone) 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 S9-mix were validated.
ST 10 C 08 caused no visible reduction in the growth of the bacterial background lawn at any dose level. The test material was, therefore, tested up to the maximum recommended dose level of 5000 µg/plate. A stringy, oily precipitate, was observed at and above 1500 µg/plate, this 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, at any dose level either with or without metabolic activation.
Under the test condition, ST 10 C 08 is not mutagenic with and without metabolic activation in S. thyphimurium strains TA1535, TA1537 TA98 & TA100, and E.coli WP2 uvrA-.
This study is considered as acceptable and satisfies the requirement for reverse gene mutation endpoint.
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