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EC number: 291-768-8 | CAS number: 90480-35-6
- Life Cycle description
- Uses advised against
- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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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:
- 18.02.-05.03.2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,6-Octadienal, 3,7-dimethyl-, acid-isomerized
- EC Number:
- 291-768-8
- EC Name:
- 2,6-Octadienal, 3,7-dimethyl-, acid-isomerized
- Cas Number:
- 90480-35-6
- IUPAC Name:
- 1-methyl-4-(propan-2-yl)benzene; ethanol
Constituent 1
Method
- Target gene:
- histidine (Salmonella typhimurium), tryptophan (Escherichia 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:
- Mammalian Microsomal Fraction S9 Mix
- Test concentrations with justification for top dose:
- - initial mutagenicity assay at 5.00, 16.0, 50.0, 160, 500, 1600, and 5000 µg/plate with and without S9
- independent confirmatory mutagenicity assay at 16.0, 50.0, 160, 500, 1600, and 5000 µg/plate with S9 and 5.00, 16.0, 50.0, 160, 500, 1600, and 5000 µg/plate without S9 - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- other: ICR-191
- Remarks:
- Without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- Method of application:
plate incorporation methodology
Duration:
- 52 ± 4 hours at 37 ± 2°C
Number of replications: 3
Acceptance criteria::
The following criteria were used to determine a valid assay:
- Salmonella tester strains must exhibit the presence of the his- mutation
- Tester strain WP2uvrA must exhibit the presence of the trp- mutation
- Salmonella tester strains must exhibit the presence of the rfa mutation
- Tester strains TA98 and TA100 must exhibit the presence of the pKM101 plasmid
- All tester strains must exhibit the presence of the uvrA or uvrB mutations
- The average revertants/plate of the vehicle control cultures must be within the acceptance limits of the laboratory historical data
- Each culture must reach a target OD650(1:4) = 0.4 to 0.6, which has been demonstrated to be representative of cultures in the late exponential or early stationary phase with ≥1x10-9 cells/mL
- The positive controls must induce a ≥ 3-fold increase in revertants/plate as compared to the concurrent vehicle controls
- A minimum of three non-toxic doses is required to evaluate assay data
- In the absence of toxicity, at least two plates per treatment level showed evidence of bacterial growth indicating the test strain and all overlay components were added correctly - Rationale for test conditions:
- These are according to the OECD guideline 471
- Evaluation criteria:
- Criteria for a Positive Response:
A test article is considered to have produced a positive response if it induces a dose-dependent increase in revertant frequency that is ≥ 2.0-fold vehicle control values for tester strains TA98, TA100, and WP2uvrA, or ≥ 3.0-fold vehicle control values for tester strains TA1535 and TA1537. In addition, any response should be reproducible.
Criteria for a Negative Response:
A test article is considered to have produced a negative response if no dose-dependent, ≥ 2.0-fold or ≥ 3.0-fold increases are observed in tester strains TA98, TA100, and WP2uvrA, or TA1535 and TA1537, respectively.
Criteria for an Equivocal Response:
Even after repeated trials, a test article may produce results that are neither clearly positive nor clearly negative (e.g., responses that do not meet the dose-dependency or fold increase requirements but are reproducible). In those instances, the test article may be considered to have produced an equivocal response.
Other criteria may be used in reaching a conclusion about the study results (e.g., comparison to historical control values, biological significance, etc.). - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the
interpretation of results, a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle 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:
- cytotoxicity
- Vehicle 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Initial mutagenicity assay:
Precipitate was observed at 5000 μg/plate in the presence and absence of S9.
Toxicity was observed at 5000 μg/plate in the presence of S9 in all tester strains except TA100, where toxicity was observed at ≥ 1600 μg/plate, and WP2uvrA, where no toxicity was observed at any tested dose level.
In the absence of S9, toxicity was observed at ≥ 500 μg/plate in all tester strains except TA98 and WP2uvrA, where toxicity was observed at ≥ 1600 and 5000 μg/plate.
Confirmatory mutagenicity assay:
Precipitate was observed at 5000 μg/plate in all tester strains in the presence and absence of S9 except TA98 and WP2uvrA, where no precipitate was observed at any tested dose level in the absence of S9. Toxicity was observed at 5000 μg/plate in all tester strains in the presence of S9 except TA1535, where toxicity was observed at ≥ 1600 μg/plate. In the absence of S9, toxicity was observed at ≥ 500 μg/plate in all tester strains except WP2uvrA, where toxicity was observed at ≥ 1600 μg/plate. - Remarks on result:
- other: not mutagenic
Any other information on results incl. tables
Tabulated results
Initial Mutagenicity Assay Results with S9
Strain | Compound | Dose level (mg/plate) |
Mean revertants per plate | SD | Ratio treated/ vehicle |
Individual revertant colony counts |
||
TA98 | Test item | 5000 | 12.7 | 0.6 | 0.5 | 13 P R | 13 P M R | 12 P M R |
1600 | 26.7 | 4 | 1.1 | 26 N | 31 N | 23 N | ||
500 | 19 | 1.7 | 0.8 | 18 N | 18 N | 21 N | ||
160 | 19.3 | 5.5 | 0.8 | 14 N | 19 N | 25 N | ||
50 | 23.3 | 4.5 | 1 | 23 N | 28 N | 19 N | ||
16 | 24.3 | 13.9 | 1 | 28 N | 9 N | 36 N | ||
5 | 23.7 | 4 | 1 | 26 N | 19 N | 26 N | ||
DMSO | 23.7 | 2.3 | 25 N | 21 N | 25 N | |||
TA100 | Test item | 5000 | 86.7 | 6.5 | 0.6 | 87 P R | 93 P R, | 80 P R |
1600 | 122.3 | 10.4 | 0.9 | 114 R | 134 R | 119 R | ||
500 | 148.3 | 27.5 | 1.1 | 150 N | 120 N | 175 N | ||
160 | 129.7 | 4.2 | 0.9 | 131 N | 133 N | 125 N | ||
50 | 151.7 | 13.3 | 1.1 | 144 N | 167 N | 144 N | ||
16 | 141 | 12 | 1 | 153 N | 141 N | 129 N | ||
5 | 129 | 7.2 | 0.9 | 123 N | 137 N | 127 N | ||
DMSO | 138.3 | 5.5 | 138 N | 144 N | 133 N | |||
TA1535 | Test item | 5000 | 8 | 2 | 0.6 | 10 P M R | 6 P R | 8 P M R |
1600 | 13 | 4 | 0.9 | 9 N | 17 N | 13 N | ||
500 | 14 | 4 | 1 | 10 N | 14 M N | 18 N | ||
160 | 16 | 0 | 1.1 | 16 N | 16 N | 16 N | ||
50 | 14 | 2 | 1 | 16 N | 12 N | 14 N | ||
16 | 15.3 | 2.9 | 1.1 | 17 N | 17 M N | 12 N | ||
5 | 13.7 | 4.5 | 1 | 9 N | 18 N | 14 N | ||
DMSO | 14 | 5.3 | 8 N | 18 N | 16 N | |||
TA1537 | Test item | 5000 | 4.3 | 1.2 | 0.5 | 3 P R | 5 P R | 5 P R |
1600 | 9 | 4 | 1.1 | 9 N | 5 N | 13 N | ||
500 | 9.3 | 2.3 | 1.1 | 12 N | 8 N | 8 N | ||
160 | 9.7 | 4 | 1.2 | 6 N | 14 N | 9 N | ||
50 | 9 | 3.6 | 1.1 | 12 N | 5 N | 10 N | ||
16 | 8.7 | 3.5 | 1 | 5 N | 12 N | 9 N | ||
5 | 9.7 | 0.6 | 1.2 | 10 N | 10 N | 9 N | ||
D | 8.3 | 4 | 9 N | 12 N | 4 N | |||
WP2uvrA | Test item | 5000 | 13.3 | 8.1 | 0.7 | 19 P N | 4 P N | 17 P N |
1600 | 22.3 | 8 | 1.2 | 14 N | 30 N | 23 N | ||
500 | 15 | 7.2 | 0.8 | 9 N | 23 N | 13 N | ||
160 | 21.7 | 4 | 1.1 | 18 N | 21 N | 26 N | ||
50 | 17 | 9.6 | 0.9 | 10 N | 13 N | 28 N | ||
16 | 14.3 | 2.5 | 0.7 | 14 N | 17 N | 12 N | ||
5 | 14.3 | 8.5 | 0.7 | 6 N | 23 N | 14 N | ||
DMSO | 19.3 | 4.7 | 23 N | 21 N | 14 N | |||
TA98 | BP | 2.5 | 517.7 | 18.9 | 21.9 | 497 N | 522 N | 534 N |
TA100 | 2AA | 2.5 | 1830.3 | 20.2 | 13.2 | 1812 N | 1827 N | 1852 N |
TA1535 | 2AA | 2.5 | 249 | 4.4 | 17.8 | 252 N | 244 N | 251 N |
TA1537 | 2AA | 2.5 | 135.3 | 25.6 | 16.2 | 111 N | 133 N | 162 N |
WP2uvrA | 2AA | 25 | 465 | 74.8 | 24.1 | 494 N | 521 N | 380 N |
Initial Mutagenicity Assay Results without S9
Strain | Compound | Dose level (g/plate) |
Mean revertants per plate | SD | Ratio treated/ vehicle |
Individual revertant colony counts |
||
TA98 | Test item | 5000 | 0 | 0 | 0 | 0 P R | 0 P R | 0 P R |
1600 | 12.3 | 6.4 | 0.8 | 5 M R | 16 R | 16 R | ||
500 | 14.3 | 2.3 | 1 | 13 N | 17 N | 13 N | ||
160 | 14 | 1 | 0.9 | 13 M N | 14 N | 15 M N | ||
50 | 16 | 4.4 | 1.1 | 14 N | 13 N | 21 M N | ||
16 | 19 | 3.6 | 1.3 | 18 N | 23 N | 16 N | ||
5 | 18.7 | 3.1 | 1.2 | 18 N | 16 N | 22 N | ||
DMSO | 15 | 4.6 | 19 N | 10 N | 16 N | |||
TA100 | Test item | 5000 | 15.3 | 7 | 0.1 | 8 P R | 22 P R | 16 P R |
1600 | 75.7 | 2.1 | 0.5 | 75 R | 74 R | 78 R | ||
500 | 114.3 | 12.1 | 0.8 | 105 R | 110 R | 128 R | ||
160 | 125 | 16.5 | 0.9 | 144 N | 116 R | 115 N | ||
50 | 127.3 | 19.6 | 0.9 | 146 N | 129 N | 107 N | ||
16 | 136.7 | 22.3 | 0.9 | 128 N | 120 N | 162 N | ||
5 | 134.7 | 1.2 | 0.9 | 134 N | 134 N | 136 N | ||
DMSO | 144.7 | 10.1 | 133 N | 151 N | 150 N | |||
TA1535 | Test item | 5000 | 0 | 0 | 0 | 0 P R | 0 P R | 0 P R |
1600 | 9.7 | 3.5 | 0.7 | 13 R | 6 R | 10 M R | ||
500 | 9 | 1 | 0.7 | 8 R | 10 R | 9 R | ||
160 | 18 | 1.7 | 1.4 | 16 N | 19 N | 19 N | ||
50 | 18.3 | 2.5 | 1.4 | 18 N | 16 N | 21 N | ||
16 | 19.3 | 2.3 | 1.5 | 18 M N | 22 N | 18 N | ||
5 | 20.7 | 2.5 | 1.6 | 21 N | 18 N | 23 N | ||
DMSO | 13.3 | 3.2 | 11 M N | 12 N | 17 N | |||
TA1537 | Test item | 5000 | 0 | 0 | 0 | 0 P R | 0 P R | 0 P R |
1600 | 5.3 | 0.6 | 0.5 | 6 R | 5 R | 5 R | ||
500 | 6 | 2.6 | 0.6 | 9 R | 4 R | 5 R | ||
160 | 7 | 2.6 | 0.7 | 5 N | 10 N | 6 N | ||
50 | 6 | 1.7 | 0.6 | 8 N | 5 N | 5 N | ||
16 | 3.7 | 4.6 | 0.4 | 1 N | 9 N | 1 N | ||
5 | 8 | 5.3 | 0.8 | 6 N | 14 N | 4 N | ||
DMSO | 10 | 5.3 | 6 N | 16 N | 8 N | |||
WP2uvrA | Test item | 5000 | 19.7 | 3.2 | 1.3 | 21 P R | 16 P R | 22 P R |
1600 | 13 | 1 | 0.9 | 13 N | 14 N | 12 N | ||
500 | 15.7 | 6.5 | 1.1 | 22 N | 9 N | 16 N | ||
160 | 15.7 | 1.5 | 1.1 | 14 N | 16 N | 17 N | ||
50 | 21.3 | 5 | 1.5 | 26 N | 22 N | 16 N | ||
16 | 16 | 7 | 1.1 | 23 N | 16 N | 9 N | ||
5 | 15.7 | 1.5 | 1.1 | 16 N | 14 N | 17 N | ||
DMSO | 14.7 | 2.1 | 13 N | 17 N | 14 N | |||
TA98 | 2NF | 1 | 348 | 32.4 | 23.2 | 321 N | 384 N | 339 N |
TA100 | SA | 2 | 1236 | 106.2 | 8.5 | 1206 N | 1148 N | 1354 N |
TA1535 | SA | 2 | 862.3 | 72.2 | 64.7 | 781 N | 887 N | 919 N |
TA1537 | ICR | 2 | 273.3 | 25 | 27.3 | 295 N | 246 N | 279 N |
WP2uvrA | 4NQO | 1 | 75.3 | 13 | 5.1 | 76 N | 62 N | 88 N |
Confirmatory Mutagenicity Assay Results with S9
Strain | Compound | Dose level (g/plate) |
Mean revertants per plate | SD | Ratio treated/ vehicle |
Individual revertant colony counts |
||
TA98 | Test item | 5000 | 21 | 3 | 0.9 | 18 P R M | 21 P R M | 24 P R M |
1600 | 26.7 | 1.2 | 1.1 | 26 N | 28 N | 26 N | ||
500 | 19.3 | 9.6 | 0.8 | 21 N | 28 N | 9 N | ||
160 | 16.3 | 3.8 | 0.7 | 12 N | 19 N | 18 N | ||
50 | 20 | 6.1 | 0.8 | 13 N | 23 N | 24 N | ||
16 | 29.3 | 9.5 | 1.2 | 22 N | 26 N | 40 N | ||
DMSO | 23.7 | 3.8 | 28 N | 21 N | 22 N | |||
TA100 | Test item | 5000 | 86.3 | 9.1 | 0.6 | 96 P R | 78 P R | 85 P R |
1600 | 115.3 | 7.1 | 0.8 | 109 N | 123 N | 114 N | ||
500 | 119.3 | 8.1 | 0.8 | 124 N | 124 N | 110 N | ||
160 | 138 | 5.2 | 1 | 135 N | 135 N | 144 N | ||
50 | 136.3 | 11.1 | 1 | 126 N | 135 N | 148 N | ||
16 | 145.7 | 5.9 | 1 | 139 N | 148 N | 150 N | ||
DMSO | 141.7 | 9.5 | 131N | 145 N | 149 N | |||
TA1535 | Test item | 5000 | 10.7 | 2.9 | 0.7 | 14 P E M | 9 P E M | 9 P E M |
1600 | 5.3 | 1.2 | 0.3 | 6 N | 6 M N | 4 M N | ||
500 | 14.7 | 2.1 | 1 | 17 N | 14 N | 13 N | ||
160 | 16 | 6.1 | 1 | 12 N | 13 N | 23 N | ||
50 | 16.3 | 3.1 | 1.1 | 19 N | 17 N | 13 N | ||
16 | 9.3 | 4 | 0.6 | 10 N | 5 N | 13 N | ||
DMSO | 15.3 | 6.5 | 15 N | 9 N | 22 N | |||
TA1537 | Test item | 5000 | 6 | 2 | 0.6 | 6 P R | 8 P R | 4 P M R |
1600 | 8 | 1.7 | 0.8 | 9 N | 9 M N | 6 N | ||
500 | 10.3 | 1.5 | 1.1 | 12 M N | 9 N | 10 N | ||
160 | 6.7 | 4.6 | 0.7 | 12 M N | 4 N | 4 M N | ||
50 | 7.7 | 0.6 | 0.8 | 7 M N | 8 N | 8 M N | ||
16 | 7.7 | 2.5 | 0.8 | 8 N | 10 N | 5 N | ||
DMSO | 9.7 | 5.9 | 12 N | 3 N | 14 N | |||
WP2uvrA | Test item | 5000 | 13.7 | 4.5 | 0.7 | 14 P R | 9 P M R | 18 P M R |
1600 | 15.3 | 5.5 | 0.8 | 21 N | 10 N | 15 N | ||
500 | 19.7 | 6.7 | 1 | 27 N | 18 N | 14 N | ||
160 | 19 | 3.5 | 1 | 21 N | 15N | 21 N | ||
50 | 14.7 | 2.5 | 0.7 | 15 N | 17 N | 12 N | ||
16 | 16.7 | 3.2 | 0.8 | 19 N | 18 N | 13 N | ||
DMSO | 19.7 | 5.1 | 24 N | 14 N | 21 N | |||
TA98 | BP | 2.5 | 450.3 | 32.6 | 19 | 486 N | 422 N | 443 N |
TA100 | 2AA | 2.5 | 1609.3 | 53.7 | 11.4 | 1615 N | 1660 N | 1553 N |
TA1535 | 2AA | 2.5 | 238.3 | 11.6 | 15.5 | 226 N | 249 N | 240 N |
TA1537 | 2AA | 2.5 | 191 | 20.9 | 19.8 | 205 N | 167 N | 201 N |
WP2uvrA | 2AA | 25 | 394 | 71.2 | 20 | 348 N | 358 N | 476 N |
Confirmatory Mutagenicity Assay Results without S9
Strain | Compound | Dose level (mg/plate) |
Mean revertants per plate | SD | Ratio treated/ vehicle |
Individual revertant colony counts |
||||
TA98 | Test item | 5000 | 6.3 | 5 | 0.4 | 7 R M | 1 R M | 11 R M | ||
1600 | 9.7 | 2.1 | 0.6 | 8 R | 12 R | 9 R | ||||
500 | 12.3 | 3.8 | 0.8 | 15 R | 14 R | 8 R | ||||
160 | 14.3 | 2.5 | 0.9 | 17 N | 12 N | 14 N | ||||
50 | 15.3 | 5.5 | 1 | 15 N | 10 N | 21 N | ||||
16 | 14.3 | 1.2 | 0.9 | 13 N | 15 N | 15 N | ||||
5 | 17.3 | 8.1 | 1.1 | 22 N | 8 N | 22 N | ||||
DMSO | 16 | 1.7 | 14 N | 17 N | 17 N | |||||
TA100 | Test item | 5000 | 2.3 | 2.5 | 0 | 5 R P M | 2 R P M | 0 R P M | ||
1600 | 75.3 | 13.4 | 0.6 | 85 R | 60 R | 81 R | ||||
500 | 90.3 | 11.7 | 0.8 | 99 R | 77 R | 95 R | ||||
160 | 120.3 | 8 | 1 | 128 N | 112 N | 121 N | ||||
50 | 115 | 7.9 | 1 | 124 N | 109 N | 112 N | ||||
16 | 134 | 12.1 | 1.1 | 127 N | 127 N | 148 N | ||||
5 | 115.3 | 2.3 | 1 | 114 N | 114 N | 118 N | ||||
DMSO | 119.3 | 8.1 | 118 N | 112 N | 128 N | |||||
TA1535 | Test item | 5000 | 0 | 0 | 0 | 0 R P M | 0 R P M | 0 R P M | ||
1600 | 11.3 | 2.9 | 0.8 | 13 R | 8 R | 13 M R | ||||
500 | 18.3 | 1.2 | 1.3 | 19 R | 19 R | 17 R | ||||
160 | 13 | 4 | 1 | 9 N | 17 N | 13 N | ||||
50 | 18.3 | 5.5 | 1.3 | 12 N | 22 N | 21 N | ||||
16 | 12.7 | 3.2 | 0.9 | 9 N | 14 N | 15 N | ||||
5 | 15.7 | 5.8 | 1.1 | 9 N | 19 N | 19 N | ||||
DMSO | 13.7 | 2.9 | 17 N | 12 N | 12 N | |||||
TA1537 | Test item | 5000 | 1 | 1 | 0.1 | 2 P R M | 1 P R M | 0 P R M | ||
1600 | 2.7 | 1.5 | 0.3 | 1 R | 4 R | 3 R | ||||
500 | 7.7 | 2.5 | 0.7 | 10 R | 8 R | 5 R | ||||
160 | 9.3 | 3.1 | 0.9 | 6 N | 10 N | 12 N | ||||
50 | 6.3 | 1.5 | 0.6 | 6 N | 5 N | 8 N | ||||
16 | 7 | 4.6 | 0.7 | 12 N | 6 M N | 3 N | ||||
5 | 8.7 | 1.2 | 0.8 | 8 N | 10 N | 8N | ||||
DMSO | 10.3 | 3.8 | 12 N | 13 N | 6 N | |||||
WP2uvrA | Test item | 5000 | 12 | 3 | 1 | 12 R | 9 R | 15 R | ||
1600 | 12.3 | 3.1 | 1 | 13 R | 9 R | 15 R | ||||
500 | 11.3 | 4.7 | 0.9 | 13 N | 6 N | 15 N | ||||
160 | 16.3 | 3.8 | 1.4 | 12 N | 19 N | 18 N | ||||
50 | 15.7 | 1.2 | 1.3 | 15 N | 17 N | 15 N | ||||
16 | 14.3 | 4 | 1.2 | 10 N | 18 N | 15 N | ||||
5 | 11 | 3.5 | 0.9 | 15 N | 9 N | 9 N | ||||
DMSO | 12 | 2 | 14 N | 10 N | 12 N | |||||
TA98 | 2NF | 1 | 298.3 | 13.6 | 18.6 | 290 N | 291 N | 314 N | ||
TA100 | SA | 2 | 1187 | 14.9 | 9.9 | 1193 N | 1170 N | 1198 N | ||
TA1535 | SA | 2 | 923 | 46.5 | 67.5 | 963 N | 872 N | 934 N | ||
TA1537 | ICR | 2 | 295 | 7.8 | 28.5 | 291 N | 304 N | 290 N | ||
WP2uvrA | 4NQO | 1 | 78.7 | 6.7 | 6.6 | 82 N M | 83 N M | 71 N M |
P = precipitation of test article observed
R = reduced background bacterial lawn
N = normal backgroud bacterial lawn
M = plate counted manually
Applicant's summary and conclusion
- Conclusions:
- The test item is negative in the Bacterial Reverse Mutation Assay tested up to 5000 µg/plate in the presence or absence of S9 under the conditions of this protocol.
- Executive summary:
The objective of this study was to evaluate the test item and/or its metabolites for its ability to induce reverse mutations at the histidine locus in Salmonella typhimurium tester strains TA98, TA100, TA1535, and TA1537, and at the tryptophan locus of Escherichia coli strain WP2uvrA. Evaluations were conducted in the presence or absence of an exogenous mammalian activation system (S9) containing microsomal enzymes. The study was performed according to OECD TG 471 and in compliance to GLP.
The test item was evaluated in the initial mutagenicity assay in all five tester strains at dose levels of 5.00, 16.0, 50.0, 160, 500, 1600, and 5000 μg/plate with and without S9. Precipitate was observed at 5000 μg/plate in the presence and absence of S9. Toxicity was observed at 5000 μg/plate in the presence of S9 in all tester strains except TA100, where toxicity was observed at ≥ 1600 μg/plate, and WP2uvrA, where no toxicity was observed at any tested dose level. In the absence of S9, toxicity was observed at ≥ 500 μg/plate in all tester strains except TA98 and WP2uvrA, where toxicity was observed at ≥ 1600 and 5000 μg/plate.
Based on the results of the initial assay, an independent confirmatory mutagenicity assay was conducted in all five tester strains at dose levels of 16.0, 50.0, 160, 500, 1600, and 5000 μg/plate with S9 and 5.00, 16.0, 50.0, 160, 500, 1600, and 5000 μg/plate without S9. Precipitate was observed at 5000 μg/plate in all tester strains in the presence and absence of S9 except TA98 and WP2uvrA, where no precipitate was observed at any tested dose level in the absence of S9. Toxicity was observed at 5000 μg/plate in all tester strains in the presence of S9 except TA1535, where toxicity was observed at ≥ 1600 μg/plate. In the absence of S9, toxicity was observed at ≥ 500 μg/plate in all tester strains except WP2uvrA, where toxicity was observed at ≥1600 μg/plate.
No increase in the mean number of revertant colonies was observed at any tested dose level in any tester strain in the presence or absence of S9 in the initial or the confirmatory assay. All positive and vehicle control values were within the acceptable ranges, and all criteria for a valid study were met.
These results indicate that the test item is negative in the Bacterial Reverse Mutation Assay tested up to 5000 μg/plate in the presence or absence of S9 under the conditions of this protocol.
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