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EC number: 609-203-4 | CAS number: 36130-02-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- June to Sep 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- preincubation modification performed only with strain TA 100
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fluocortolone
- EC Number:
- 205-811-5
- EC Name:
- Fluocortolone
- Cas Number:
- 152-97-6
- Molecular formula:
- C22H29FO4
- IUPAC Name:
- 6-fluoro-11,21-dihydroxy-16-methylpregna-1,4-diene-3,20-dione
- Details on test material:
- - Name of test material (as cited in study report): fluocortolone (ZK 10445)
- Lot/batch No.: 14030955
Constituent 1
Method
- Target gene:
- Histidine gene locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1537
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate (S9 mix)
- Test concentrations with justification for top dose:
- without preincubation: 0.1, 0.25, 0.5, 1.0, 2.5, 5.0 mg/plate
with preincubation: 0.1, 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.0 mg/plate (only S. typhymurium TA100) - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without metabolic activation: 9-AA, 2-NF, NaN3, with metabolic activation: 2-AA, BP, CP; in test with preincubation additionally DMNA was used as positive control.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- growth inhibition starting at 0.75 mg/plate (preincubation procedure) or at 1.0 mg/plate (plate incorporation procedure)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- growth inhibition starting at 0.75 mg/plate (preincubation procedure) or at 1.0 mg/plate (plate incorporation procedure)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- growth inhibition starting at 0.75 mg/plate (preincubation procedure) or at 1.0 mg/plate (plate incorporation procedure)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- growth inhibition starting at 0.75 mg/plate (preincubation procedure) or at 1.0 mg/plate (plate incorporation procedure)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- growth inhibition starting at 0.75 mg/plate (preincubation procedure) or at 1.0 mg/plate (plate incorporation procedure)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
None of the five tester strains showed increased reversion to prototrophy with fluocortolone (ZK 10.445) at the concentrations tested, either in the presence or absence of S9 mix. Also in an additionally performed test with TA 100 using the preincubation procedure ZK 10.445 did not show a mutagenic effect.
Growth inhibition of the background lawn could be observed on TA 1535, starting at 1 mg/plate, on TA 1537 and TA 1538 starting at 2.5 mg/plate and in the preincubation procedure on TA 100 starting at 0.75 mg/plate.
Precipitates in the ag ar were found partially in the preincubation test at 6.0 mg/plate.
Negative controls and positive controls with known mutagens (9-aminoacridine, anthracene-2-amine;benzo(a)pyrene, cyclophosphamide, 2-nitrofluorene, sodium azide) produced the expected numbers of revertant colonies.
TA 1535 plate incorporation | |||||||
Addition | Amount/plate | with S9 mix | without S9 mix | ||||
individual plate count | mean | SD | individual plate count | mean | SD | ||
DMSO | 0.1 mL | 17 |
|
| 24 |
|
|
|
| 13 | 15 | 2.0 | 16 | 22 | 4.9 |
|
| 15 |
|
| 25 |
|
|
phosphate buffer |
| 15 |
|
| 26 |
|
|
|
| 12 | 16 | 4.2 | 27 | 25 | 3.2 |
|
| 21 |
|
| 21 |
|
|
2-AA | 2.0 µg | 225 |
|
| 23 |
|
|
|
| 191 | 203 | 19.1 | 16 | 18 | 4.0 |
|
| 193 |
|
| 16 |
|
|
CP | 400.0µg | 289 |
|
| 37 |
|
|
|
| 381 | 345 | 49.4 | 43 | 45 | 8.6 |
|
| 366 |
|
| 54 |
|
|
test item | 0.1 mg | 21 |
|
| 14 |
|
|
|
| 18 | 16 | 6.8 | 19 | 22 | 9.3 |
|
| 8 |
|
| 32 |
|
|
| 0.25 mg | 13 |
|
| 26 |
|
|
|
| 11 | 13 | 2.0 | 32 | 29 | 3.1 |
|
| 15 |
|
| 28 |
|
|
| 0.5 mg | 13 |
|
| 26 |
|
|
|
| 21 | 14 | 7.0 | 25 | 25 | 1.5 |
|
| 7 |
|
| 23 |
|
|
| 1.0 mg | 11 |
|
| 24 |
|
|
|
| 12 | 12 | 1.0 | 23 | 221 | 3.2 |
|
| 13 |
|
| 18 |
|
|
| 2.5 mg | 11 |
|
| 7 |
|
|
|
| 11 | 11 | 0.0 | 14 | 91 | 4.4 |
|
| 11 |
|
| 6 |
|
|
| 5.0 mg | 2 |
|
| 1 |
|
|
|
| 4 | 31 | 1.2 | 1 | 11 | 0.6 |
|
| 4 |
|
| 0 |
|
|
cell population: 2E+08per plate; 1 background lawn reduced
| |||||||
TA 100 plate incorporation | |||||||
Addition | Amount/plate | with S9 mix | without S9 mix | ||||
individual plate count | mean | SD | individual plate count | mean | SD | ||
DMSO | 0.1 mL | 106 |
|
| 128 |
|
|
|
| 93 | 97 | 8.1 | 86 | 104 | 21.8 |
|
| 91 |
|
| 97 |
|
|
phosphate buffer | 0.1 mL | 112 |
|
| 148 |
|
|
|
| 85 | 101 | 14.4 | 105 | 127 | 30.4 |
|
| 107 |
|
| - |
|
|
2-AA | 2.0 µg | 1107 |
|
| 90 |
|
|
|
| 1127 | 1160 | 75.7 | 100 | 98 | 6.8 |
|
| 1247 |
|
| 103 |
|
|
BP | 5.0µg | 273 |
|
| 86 |
|
|
|
| 235 | 267 | 29.5 | 107 | 91 | 14.6 |
|
| 293 |
|
| 79 |
|
|
NaN3 | 2.0 µg | 478 |
|
| 718 |
|
|
|
| 476 | 476 | 1.5 | 706 | 711 | 6.4 |
|
| 475 |
|
| 708 |
|
|
test item | 0.25 mg | 85 |
|
| 101 |
|
|
|
| 88 | 85 | 3.0 | 96 | 100 | 4.0 |
|
| 82 |
|
| 104 |
|
|
| 0.5 mg | 103 |
|
| 95 |
|
|
|
| 73 | 88 | 21.2 | 90 | 93 | 1.5 |
|
| - |
|
| - |
|
|
| 1.0 mg | 88 |
|
| 111 |
|
|
|
| 97 | 97 | 8.5 | 102 | 101 | 10.5 |
|
| 105 |
|
| 90 |
|
|
| 2.5 mg | 117 |
|
| 111 |
|
|
|
| 81 | 96 | 18.7 | 115 | 107 | 10.6 |
|
| 90 |
|
| 95 |
|
|
| 5.0 mg | 96 |
|
| 91 |
|
|
|
| 76 | 92 | 14.8 | 77 | 76 | 15.5 |
|
| 105 |
|
| 60 |
|
|
cell population: 3 E+08 per plate; - not tested
| |||||||
TA 100 (b) plate incorporation | |||||||
Addition | Amount/plate | with S9 mix | without S9 mix | ||||
|
| individual plate count | mean | SD | individual plate count | mean | SD |
DMSO | 0.1 mL | 88 |
|
| 89 | 87 | 11.7 |
|
| 80 | 81 | 7.0 | 97 |
|
|
|
| 74 |
|
| 74 |
|
|
phosphate buffer | 0.1 mL | 101 |
|
| 107 | 111 | 3.5 |
|
| 87 | 89 | 10.7 | 111 |
|
|
|
| 80 |
|
| 114 |
|
|
2-AA | 2.0 µg | 1081 |
|
| 87 | 96 | 7.8 |
|
| 1010 | 908 | 240.0 | 100 |
|
|
|
| 634 |
|
| 101 |
|
|
BP | 5.0µg | 298 |
|
| 120 | 110 | 12.3 |
|
| 324 | 297 | 27.5 | 113 |
|
|
|
| 269 |
|
| 96 |
|
|
NaN3 | 2.0 µg | 297 |
|
| 509 | 501 | 31.2 |
|
| 320 | 312 | 12.7 | 528 |
|
|
|
| 318 |
|
| 467 |
|
|
test item | 0.1 mg | 88 |
|
| 110 | 113 | 3.8 |
|
| 96 | 93 | 4.4 | 117 |
|
|
|
| 95 |
|
| 111 |
|
|
| 0.25 mg | 85 |
|
| 96 | 104 | 9.2 |
|
| 78 | 85 | 7.5 | 114 |
|
|
|
| 93 |
|
| 102 |
|
|
| 0.5 mg | 93 |
|
| 92 | 108 | 15.5 |
|
| 76 | 85 | 8.6 | 123 |
|
|
|
| 87 |
|
| 108 |
|
|
| 1.0 mg | 77 |
|
| 133 | 123 | 12.3 |
|
| 90 | 86 | 7.8 | 109 |
|
|
|
| 91 |
|
| 126 |
|
|
| 2.5 mg | 94 |
|
| 134 | 127 | 17.0 |
|
| 104 | 105 | 11.0 | 140 |
|
|
|
| 116 |
|
| 108 |
|
|
| 5.0 mg | 80 |
|
| 100 | 107 | 12.4 |
|
| 63 | 79 | 16.0 | 99 |
|
|
|
| 95 |
|
| 121 |
|
|
cell population: 1E+08 per plate
| |||||||
TA1537 plate incorporation | |||||||
Addition | Amount/plate | with S9 mix | without S9 mix | ||||
individual plate count | mean | SD | individual plate count | mean | SD | ||
DMSO | 0.1 mL | 18 |
|
| 12 |
|
|
|
| 12 | 13 | 4.2 | 7 | 10 | 2.5 |
|
| 10 |
|
| 10 |
|
|
2-AA | 5.0 µg | 152 |
|
| 8 |
|
|
|
| 194 | 188 | 33.4 | 5 | 7 | 1.5 |
|
| 218 |
|
| 7 |
|
|
BP | 10.0 µg | 33 |
|
| 6 |
|
|
|
| 43 | 35 | 6.8 | 10 | 7 | 2.6 |
|
| 30 |
|
| 5 |
|
|
2-NF | 10.0 µg | 80 |
|
| 53 |
|
|
|
| 79 | 87 | 13.6 | 49 | 57 | 10.0 |
|
| 103 |
|
| 68 |
|
|
9-AA | 100.0 µg | - |
|
| 601 |
|
|
|
| - | - | - | 530 | 561 | 36.3 |
|
| - |
|
| 552 |
|
|
test item | 0.1 mg | 11 |
|
| 8 |
|
|
|
| 10 | 12 | 2.1 | 13 | 9 | 3.6 |
|
| 14 |
|
| 6 |
|
|
| 0.25 mg | 13 |
|
| 13 |
|
|
|
| 17 | 14 | 2.6 | 9 | 10 | 2.6 |
|
| 12 |
|
| 8 |
|
|
| 0.5 mg | 15 |
|
| 9 |
|
|
|
| 9 | 14 | 4.2 | 9 | 8 | 2.3 |
|
| 17 |
|
| 5 |
|
|
| 1.0 mg | 12 |
|
| 17 |
|
|
|
| 11 | 13 | 2.1 | 7 | 10 | 6.1 |
|
| 15 |
|
| 6 |
|
|
| 2.5 mg | 9 |
|
| 8 |
|
|
|
| 9 | 9 | 0.6 | 2 | 51 | 3.1 |
|
| 8 |
|
| 4 |
|
|
| 5.0 mg | 1 |
|
| 2 |
|
|
|
| 3 | 3 | 1.5 | 6 | 31 | 2.6 |
|
| 4 |
|
| 1 |
|
|
cell population: 8 E+07 per plate - not tested; 1 background lawn reduced
| |||||||
TA1538 plate incorporation | |||||||
Addition | Amount/plate | with S9 mix | without S9 mix | ||||
individual plate count | mean | SD | individual plate count | mean | SD | ||
DMSO | 0.1 mL | 26 |
|
| 11 |
|
|
|
| 31 | 32 | 6.6 | 23 | 17 | 6.0 |
|
| 39 |
|
| 18 |
|
|
2-AA | 5.0 µg | 1839 |
|
| 34 |
|
|
|
| 1561 | 1630 | 184.0 | 23 | 30 | 6.4 |
|
| 1491 |
|
| 34 |
|
|
BP | 10.0 µg | 99 |
|
| 19 |
|
|
|
| 109 | 99 | 10.5 | 20 | 17 | 4.4 |
|
| 88 |
|
| 12 |
|
|
2-NF | 10.0 µg | 448 |
|
| 1166 |
|
|
|
| 421 | 434 | 13.5 | 1306 | 1239 | 70.2 |
|
| 434 |
|
| 1245 |
|
|
test item | 0.1 mg | 29 |
|
| 17 |
|
|
|
| 30 | 33 | 6.1 | 13 | 15 | 2.1 |
|
| 40 |
|
| 14 |
|
|
| 0.25 mg | 42 |
|
| 18 |
|
|
|
| 21 | 33 | 10.8 | 11 | 15 | 3.5 |
|
| 36 |
|
| 15 |
|
|
| 0.5 mg | 38 |
|
| 11 |
|
|
|
| 35 | 37 | 1.7 | 11 | 11 | 0.6 |
|
| 38 |
|
| 12 |
|
|
| 1.0 mg | 31 |
|
| 14 |
|
|
|
| 29 | 30 | 1.2 | 16 | 16 | 2.0 |
|
| 29 |
|
| 18 |
|
|
| 2.5 mg | 32 |
|
| 8 |
|
|
|
| 33 | 34 | 2.6 | 8 | 81 | 0.6 |
|
| 37 |
|
| 9 |
|
|
| 5.0 mg | 31 |
|
| 7 |
|
|
|
| 16 | 25 | 8.1 | 4 | 61 | 2.1 |
|
| 29 |
|
| 8 |
|
|
cell population: 8E+07 per plate 1 background lawn reduced
| |||||||
TA 98 plate incorporation | |||||||
Addition | Amount/plate | with S9 mix | without S9 mix | ||||
individual plate count | mean | SD | individual plate count | mean | SD | ||
DMSO | 0.1 mL | 44 |
|
| 31 |
|
|
|
| 35 | 38 | 5.2 | 18 | 29 | 9.7 |
|
| 35 |
|
| 37 |
|
|
2-AA | 5.0 µg | 1007 |
|
| 21 |
|
|
|
| 900 | 956 | 53.7 | 33 | 27 | 6.0 |
|
| 962 |
|
| 27 |
|
|
BP | 10.0 µg | 129 |
|
| 22 |
|
|
|
| 122 | 124 | 4.0 | 26 | 28 | 6.7 |
|
| 122 |
|
| 35 |
|
|
2-NF | 10.0 µg | 99 |
|
| 180 |
|
|
|
| 112 | 100 | 11.5 | 205 | 196 | 13.7 |
|
| 89 |
|
| 202 |
|
|
test item | 0.1 mg | 38 |
|
| 33 |
|
|
|
| 37 | 37 | 1.5 | 25 | 28 | 4.2 |
|
| 35 |
|
| 27 |
|
|
| 0.25 mg | 44 |
|
| 24 |
|
|
|
| 41 | 39 | 6.2 | 21 | 23 | 2.1 |
|
| 32 |
|
| 25 |
|
|
| 0.5 mg | 43 |
|
| 20 |
|
|
|
| 33 | 38 | 5.0 | 26 | 22 | 3.2 |
|
| 37 |
|
| 21 |
|
|
| 1.0 mg | 45 |
|
| 24 |
|
|
|
| 32 | 37 | 7.2 | 13 | 21 | 7.4 |
|
| 33 |
|
| 27 |
|
|
| 2.5 mg | 40 |
|
| 24 |
|
|
|
| 39 | 38 | 2.6 | 25 | 24 | 0.6 |
|
| 35 |
|
| 24 |
|
|
| 5.0 mg | 36 |
|
| 37 |
|
|
|
| 46 | 44 | 6.8 | 24 | 27 | 8.5 |
|
| 49 |
|
| 21 |
|
|
cell population: 2 E+08 per plate |
TA 100 preincubation (c) | ||||||||||
Addition | Amount/plate | with 10% S9 mix | With 30% S9 mix | without S9 mix | ||||||
individual plate count | mean | SD | individual plate count | mean | SD | individual plate count | mean | SD | ||
DMSO | 0.1 mL | 76 |
|
| 84 |
|
| 95 |
|
|
|
| 75 | 77 | 3.2 | 79 | 84 | 4.5 | 79 | 84 | 9.9 |
|
| 81 |
|
| 88 |
|
| 77 |
|
|
phosphate buffer | 0.1 mL | 96 |
|
| 102 |
|
| 95 |
|
|
|
| 100 | 97 | 2.6 | 123 | 111 | 11.0 | 89 | 96 | 7.5 |
|
| 95 |
|
| 107 |
|
| 104 |
|
|
2-AA | 2.0 µg | 545 |
|
| 263 |
|
| 106 |
|
|
|
| 522 | 563 | 52.4 | 262 | 268 | 9.5 | 101 | 100 | 6.6 |
|
| 622 |
|
| 279 |
|
| 93 |
|
|
NaN3 | 2.0 µg | 398 |
|
| 183 |
|
| 615 |
|
|
|
| 419 | 409 | 10.6 | 199 | 189 | 8.7 | 572 | 594 | 21.5 |
|
| 411 |
|
| 185 |
|
| 595 |
|
|
N-nitroso-dimethylamine | 5 µL | 167 |
|
| 1215 |
|
| 119 |
|
|
|
| 190 | 174 | 14.2 | 1197 | 1246 | 70.0 | 109 | 106 | 15.3 |
|
| 164 |
|
| 1326 |
|
| 89 |
|
|
test item | 0.1 mg | 120 |
|
| 90 |
|
| 100 |
|
|
|
| 94 | 102 | 15.3 | 76 | 88 | 11.1 | 83 | 87 | 11.2 |
|
| 93 |
|
| 98 |
|
| 79 |
|
|
| 0.25 mg | 95 |
|
| 96 |
|
| 102 |
|
|
|
| 90 | 91 | 3.6 | 77 | 86 | 9.5 | 93 | 97 | 4.6 |
|
| 88 |
|
| 86 |
|
| 96 |
|
|
| 0.5 mg | 84 |
|
| 94 |
|
| 71 |
|
|
|
| 88 | 88 | 4.5 | 98 | 90 | 10.0 | 76 | 83 | 17.1 |
|
| 93 |
|
| 79 |
|
| 103 |
|
|
| 0.75 mg | 99 |
|
| 85 |
|
| 66 |
|
|
|
| 68 | 84 | 15.6 | 94 | 89 | 4.7 | 74 | 651 | 9.5 |
|
| 86 |
|
| 87 |
|
| 55 |
|
|
| 1.0 mg | 76 |
|
| 96 |
|
| 51 |
|
|
|
| 94 | 87 | 9.6 | 101 | 104 | 9.8 | 44 | 481 | 4.9 |
|
| 91 |
|
| 115 |
|
| - |
|
|
| 2.0 mg | 60 |
|
| 103 |
|
|
|
|
|
|
| 95 | 741 | 18.3 | 67 | 881 | 18.7 |
|
|
|
|
| 68 |
|
| 94 |
|
|
|
|
|
| 4.0 mg | 37 |
|
| 58 |
|
|
|
|
|
|
| 50 | 441 | 6.5 | 66 | 631 | 4.2 |
|
|
|
|
| 44 |
|
| 64 |
|
|
|
|
|
| 6.0 mg | 20p |
|
| 21 |
|
|
|
|
|
|
| 26p | 221 | 3.8 | 24 | 341 |
|
|
|
|
|
| 19p |
|
| 56 |
|
|
|
|
|
cell population: 1 E+08 per plate -: plate contaminated 1: background lawn reduced p: precipitates |
Applicant's summary and conclusion
- Conclusions:
- Fluocortolone was tested for mutagenic activity effects in five histidine-dependent strains of S. typhimurium (TA1535, TA100, TA1537, TA1538, TA98) using the direct plate incorporation procedure. The study was performed with and without metabolic activation, employed a range of fluocortolon concentrations from 0.1 to 6.0 mg per plate. No increased reversion to prototrophy were seen neither without nor with metabolic activation. Growth inhibition of the background lawn was observed at fluocortolone concentrations starting at 1.0 mg/plate. An additionally performed test with strain TA 100 using the preincubation procedure did not show a mutagenic effect of the test item. Precipitates were found partially in the preincubation test at 6.0 mg per plate.
- Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471 (1983), Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 were exposed to Fluocortolon in DMSO in concentrations of 0.1, 0.25, 0.5, 1.0, 2.5, 5.0 mg/plate in the absence and presence of mammalian metabolic activation (rat liver S9 mix) in the plate incorporation assay and with the preincubation method at concentrations of 0.1, 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.0 mg/plate (only S. typhimurium TA100). Cytotoxicity was observed from 1.0 and 0.75 mg/plate upwards with the plate incorporation method and the preincubation method, respectively.
Precipitation was partially observed at the highest concentration (6.0 mg/plate). The positive controls induced the appropriate responses in the corresponding strains. The mean numbers of revertant colonies in the negative controls were within the ranges of the historical control data.
There was no evidence of an increase in the number of revertant colonies that exceeded twice background in any of the tester strains (TA98, TA 100, TA1538, TA1535, and TA1537) examined at dose levels up to 6.0 mg/plate in the absence and presence of a metabolic activation source (S9). Therefore, test substance was considered to be non-genotoxic (non-mutagenic) under the conditions employed (plate incorporation/preincubation assay).
There was no evidence of induced mutant colonies over background.
Under the conditions of the study, the test substance was negative for mutagenic potential.
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