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EC number: 601-489-9 | CAS number: 1176-81-4
- 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:
- Mar to Apr 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- yes
- Remarks:
- no E. coli WP2 or S. typhimurium TA102 strain tested; only one experiment (direct plate incorporation procedure) was performed
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 21-Acetoxy-6alpha-fluoro-11ß-hydroxy-16alpha-methyl-4-pregnene-3,20-dione
- EC Number:
- 601-489-9
- Cas Number:
- 1176-81-4
- Molecular formula:
- C24 H33 F O5
- IUPAC Name:
- 21-Acetoxy-6alpha-fluoro-11ß-hydroxy-16alpha-methyl-4-pregnene-3,20-dione
- Details on test material:
- - Name of test material (as cited in study report): fluocortolone-A-acetate (ZK 47525)
- Analytical purity: 94.63%
- Lot/batch No.: 87010241
Constituent 1
Method
- Target gene:
- Histidine gene locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1538
- 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 1535
- 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 98
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced male rat liver S9 mix
Type and composition of metabolic activation system:
- source of S9: Liver homogenates (S9:9000xg fraction), derived from male Sprague-Dawley rats pre-treated with Aroclor 1254, was obtained from CN/Cappel Pharmaceuticals, Inc., Aurora, Ohio, USA, [S9 batch no. 99554; protein content 37.3 mg/mL; EROD activity: 2627.3 pmoles 7-hydroxyresorufin/min/mg S9 protein].
- concentration or volume of S9 mix and S9 in the final culture medium: 0.5 mL of S9 mix were added to each bacterial culture with a volume of approx. 2.55 mL - Test concentrations with justification for top dose:
- 0.1, 0.25, 0.5, 1.0, 2.5, 5.0 mg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- cyclophosphamide
- other: 4-nitro-o-phenylenediamine (only TA 1537) 10 µg/plate without S9, 2-aminoanthracene (all strains) 5 µg/plate with S9
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration triplicate
- Number of independent experiments one
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): Aliquots of a E-06 dilution of the overnight culture were spread onto complete agar to measure the viability and cell densityof each culture.
- Test substance added in agar (plate incorporation)
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: background growth inhibition
METHODS FOR MEASUREMENTS OF GENOTOXICITY
The plates were scored for the number of mutant colonies with an automated colony counter (Artek M 982B, Artek Systems Corporation, Farmingdale, NY, USA). In exceptional cases, where reliable automatic counting is not possible, e.g. due to distinct precipitates of the test compound, the colonies are scored manually. - Evaluation criteria:
- The arithmetic means of the number of mutant colonies of the 3 parallel plates in the negative control groups were compared with those of the compound groups. A positive. response was considered if the number of revertants of the compound groups compared to the number of revertants of the negative group was reproducibly higher than 2-fold. A dose-dependent increase in the number of revertants was also considered to indicate a mutagenic effect.
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 at 5.0 mg/plate
- Vehicle controls validity:
- valid
- Untreated 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 at 5.0 mg/plate
- Vehicle controls validity:
- valid
- Untreated 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 at 5.0 mg/plate
- Vehicle controls validity:
- valid
- Untreated 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 at 5.0 mg/plate
- Vehicle controls validity:
- valid
- Untreated 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 at 5.0 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
The total colony counts of the 10 -6 dilution of bacterial suspension culture confirmed the viability and high cell density of the cultures of the individual strains.The colony counts recorded on appropriate negative control plates confirmed the characteristically spontaneous reversion rates of the tester strains. Appropriate positive control chemicals induced marked increases in revertant colony numbers with all strains.
None of the five tester strains showed increased reversion to prototrophy with ZK 47525 (fluocortolone-A-acetate) at the concentrations tested between 0.1 and 5.0 mg/plate, either in the absence or presence of S9 mix.
Precipitates in the agar were found starting at 1.0 mg/plate onwards. Growth inhibition of the background lawn was observed at the highest concentration tested.
TA 1535 |
| Revertants per plate | Quotient | ||||||
Dose/Plate | -S9 | M | SD | +S9 | M | SD | -S9 | +S9 | |
DMSO | 50µL | 35 | 41 | 6 | 15 | 15 | 1 | 1.0 | 1.0 |
|
| 46 |
|
| 15 |
|
|
|
|
|
| 41 |
|
| 14 |
|
|
|
|
Phosphate Buffer | 50µL | 52 | 55 | 8 | 16 | 15 | 1 | 1.4 | 1.0 |
|
| 64 |
|
| 15 |
|
|
|
|
|
| 49 |
|
| 14 |
|
|
|
|
Test item | 0.10mg | 52 | 52 | 10 | 14 | 13 | 1 | 1.3 | 0.9 |
|
| 42 |
|
| 13 |
|
|
|
|
|
| 61 |
|
| 13 |
|
|
|
|
| 0.25mg | 62 | 60 | 2 | 17 | 19 | 2 | 1.5 | 1.3 |
|
| 60 |
|
| 18 |
|
|
|
|
|
| 59 |
|
| 21 |
|
|
|
|
| 0.50mg | 42 | 49 | 6 | 18 | 19 | 2 | 1.2 | 1.3 |
|
| 51 |
|
| 21 |
|
|
|
|
|
| 54 |
|
| 17 |
|
|
|
|
| 1.0mg | 41P | 45 | 3 | 21P | 20 | 1 | 1.1 | 1.3 |
|
| 46P |
|
| 19P |
|
|
|
|
|
| 47P |
|
| 19P |
|
|
|
|
| 2.5mg | 40 mP | 37 | 3 | 17 mP | 17 | 2 | 0.9 | 1.1 |
|
| 35 mP |
|
| 18mP |
|
|
|
|
|
| 37 mP |
|
| 15 mP |
|
|
|
|
| 5.0mg | 30 mPB | 31 | 2 | 18 mPB | 17 | 2 | 0.8 | 1.1 |
|
| 33 mPB |
|
| 15 mPB |
|
|
|
|
|
| 30 mPB |
|
| 17 mPB |
|
|
|
|
2-AA | 5µg | 55 | 58 | 2 | 113 | 129 | 20 | 1.4 | 8.8 |
|
| 59 |
|
| 151 |
|
|
|
|
|
| 59 |
|
| 124 |
|
|
|
|
CP | 400µg | 101 | 96 | 8 | 195 | 205 | 9 | 2.4 | 14.0 |
|
| 101 |
|
| 207 |
|
|
|
|
|
| 87 |
|
| 212 |
|
|
|
|
NaN3 | 5µg | 361 | 365 | 7 | 39 | 46 | 8 | 9.0 | 3.1 |
|
| 373 |
|
| 55 |
|
|
|
|
|
| 360 |
|
| 44 |
|
|
|
|
| |||||||||
TA 100 |
| Revertants per plate | Quotient | ||||||
Dose/Plate | -S9 | M | SD | +S9 | M | SD | -S9 | +S9 | |
DMSO | 50µL | 128 | 144 | 14 | 111 | 105 | 5 | 1.0 | 1.0 |
|
| 147 |
|
| 103 |
|
|
|
|
|
| 156 |
|
| 101 |
|
|
|
|
Phosphate Buffer | 50µL | 135 | 139 | 12 | 110 | 113 | 16 | 1.0 | 1.1 |
|
| 129 |
|
| 131 |
|
|
|
|
|
| 153 |
|
| 99 |
|
|
|
|
Test item | 0.10mg | 147 | 148 | 14 | 113 | 112 | 6 | 1.0 | 1.1 |
|
| 135 |
|
| 118 |
|
|
|
|
|
| 162 |
|
| 106 |
|
|
|
|
| 0.25mg | 113 | 131 | 15 | 103 | 107 | 5 | 0.9 | 1.0 |
|
| 138 |
|
| 112 |
|
|
|
|
|
| 141 |
|
| 107 |
|
|
|
|
| 0.50mg | 145 | 147 | 2 | 100 | 105 | 5 | 1.0 | 1.0 |
|
| 147 |
|
| 109 |
|
|
|
|
|
| 149 |
|
| 107 |
|
|
|
|
| 1.0mg | 147P | 138 | 12 | 117P | 115 | 10 | 1.0 | 1.1 |
|
| 142P |
|
| 104P |
|
|
|
|
|
| 125P |
|
| 123P |
|
|
|
|
| 2.5mg | 145 mP | 145 | 6 | 111 mP | 124 | 13 | 1.0 | 1.2 |
|
| 139 mP |
|
| 123 mP |
|
|
|
|
|
| 150 mP |
|
| 137 mP |
|
|
|
|
| 5.0mg | 150 mPB | 137 | 12 | 109 mPB | 105 | 5 | 1.0 | 1.0 |
|
| 129 mPB |
|
| 100 mPB |
|
|
|
|
|
| 131 mPB |
|
| 106 mPB |
|
|
|
|
2-AA | 5µg | 229 | 220 | 16 | 1554 | 1602 | 56 | 1.5 | 15.3 |
|
| 202 |
|
| 1589 |
|
|
|
|
|
| 230 |
|
| 1664 |
|
|
|
|
B[a]P | 2.5µg | 135 | 130 | 7 | 1153 | 1007 | 165 | 0.9 | 9.6 |
|
| 122 |
|
| 1040 |
|
|
|
|
|
| 134 |
|
| 828 |
|
|
|
|
NaN3 | 5µg | 1109 | 1023 | 77 | 294 | 348 | 49 | 7.1 | 3.3 |
|
| 960 |
|
| 360 |
|
|
|
|
|
| 999 |
|
| 389 |
|
|
|
|
| |||||||||
TA 1537 |
| Revertants per plate | Quotient | ||||||
Dose/Plate | -S9 | M | SD | +S9 | M | SD | -S9 | +S9 | |
DMSO | 50µL | 13 | 20 | 6 | 18 | 19 | 4 | 1.0 | 1.0 |
|
| 23 |
|
| 23 |
|
|
|
|
|
| 24 |
|
| 16 |
|
|
|
|
Phosphate Buffer | 50µL | 28 | 24 | 4 | 15 | 17 | 4 | 1.2 | 0.9 |
|
| 21 |
|
| 14 |
|
|
|
|
|
| 23 |
|
| 21 |
|
|
|
|
Test item | 0.10mg | 25 | 21 | 9 | 16 | 15 | 1 | 1.1 | 0.8 |
|
| 11 |
|
| 15 |
|
|
|
|
|
| 27 |
|
| 15 |
|
|
|
|
| 0.25mg | 19 | 23 | 4 | 7 | 15 | 8 | 1.1 | 0.8 |
|
| 23 |
|
| 17 |
|
|
|
|
|
| 26 |
|
| 22 |
|
|
|
|
| 0.50mg | 19 | 19 | 1 | 14 | 13 | 3 | 1.0 | 0.7 |
|
| 20 |
|
| 10 |
|
|
|
|
|
| 18 |
|
| 15 |
|
|
|
|
| 1.0mg | 22P | 21 | 3 | 12P | 13 | 1 | 1.1 | 0.7 |
|
| 24P |
|
| 14P |
|
|
|
|
|
| 18P |
|
| 13P |
|
|
|
|
| 2.5mg | 19P | 19 | 5 | 10 mP | 11 | 2 | 1.0 | 0.6 |
|
| 15 mP |
|
| 9 mP |
|
|
|
|
|
| 24 mP |
|
| 13 mP |
|
|
|
|
| 5.0mg | 25 mPB | 17 | 7 | 9 mPB | 13 | 4 | 0.9 | 0.7 |
|
| 13 mPB |
|
| 15 mPB |
|
|
|
|
|
| 14 mPB |
|
| 16 mPB |
|
|
|
|
2-AA | 5.0 µg | 24 | 29 | 6 | 155 | 137 | 16 | 1.5 | 7.2 |
|
| 35 |
|
| 127 |
|
|
|
|
|
| 28 |
|
| 128 |
|
|
|
|
4-NPDA | 10.0 µg | 71 | 72 | 1 | 33 | 32 | 2 | 3.6 | 1.7 |
|
| 73 |
|
| 33 |
|
|
|
|
|
| 73 |
|
| 30 |
|
|
|
|
| |||||||||
TA 1538 |
| Revertants per plate | Quotient | ||||||
Dose/Plate | -S9 | M | SD | +S9 | M | SD | -S9 | +S9 | |
DMSO | 50µL | 11 | 12 | 1 | 19 | 17 | 3 | 1.0 | 1.0 |
|
| 12 |
|
| 13 |
|
|
|
|
|
| 12 |
|
| 19 |
|
|
|
|
Phosphate Buffer | 50µL | 9 | 12 | 3 | 31 | 28 | 3 | 1.1 | 1.7 |
|
| 14 |
|
| 28 |
|
|
|
|
|
| 14 |
|
| 26 |
|
|
|
|
Test item | 0.10mg | 11 | 16 | 5 | 23 | 23 | 1 | 1.4 | 1.3 |
|
| 16 |
|
| 23 |
|
|
|
|
|
| 21 |
|
| 22 |
|
|
|
|
| 0.25mg | 13 | 10 | 3 | 20 | 20 | 9 | 0.9 | 1.2 |
|
| 7 |
|
| 12 |
|
|
|
|
|
| 11 |
|
| 29 |
|
|
|
|
| 0.50mg | 14 | 15 | 2 | 19 | 21 | 2 | 1.3 | 1.3 |
|
| 14 |
|
| 22 |
|
|
|
|
|
| 18 |
|
| 23 |
|
|
|
|
| 1.0mg | 14 mP | 13 | 1 | 26P | 19 | 6 | 1.1 | 1.1 |
|
| 13 mP |
|
| 15 mP |
|
|
|
|
|
| 12 mP |
|
| 16 mP |
|
|
|
|
| 2.5mg | 10 mP | 11 | 3 | 18 mP | 16 | 3 | 0.9 | 1.0 |
|
| 14 mP |
|
| 13 mP |
|
|
|
|
|
| 9 mP |
|
| 18 mP |
|
|
|
|
| 5.0mg | 9 mPB | 12 | 3 | 17 mPB | 16 | 3 | 1.0 | 1.0 |
|
| 12 mPB |
|
| 13 mPB |
|
|
|
|
|
| 14 mPB |
|
| 19 mPB |
|
|
|
|
2-NF | 10µg | 23 | 24 | 2 | 959 | 1114 | 150 | 2.1 | 65.5 |
|
| 26 |
|
| 1123 |
|
|
|
|
|
| 23 |
|
| 1259 |
|
|
|
|
2-AA | 5µg | 1303 | 1326 | 75 | 598 | 530 | 67 | 113.7 | 31.2 |
|
| 1266 |
|
| 465 |
|
|
|
|
|
| 1410 |
|
| 526 |
|
|
|
|
| |||||||||
TA 98 |
| Revertants per plate | Quotient | ||||||
Dose/Plate | -S9 | M | SD | +S9 | M | SD | -S9 | +S9 | |
DMSO | 50µL | 30 | 35 | 5 | 32 | 34 | 2 | 1.0 | 1.0 |
|
| 35 |
|
| 34 |
|
|
|
|
|
| 40 |
|
| 36 |
|
|
|
|
Phosphate Buffer | 50µL | 30 | 41 | 11 | 32 | 33 | 1 | 1.2 | 1.0 |
|
| 42 |
|
| 34 |
|
|
|
|
|
| 51 |
|
| 33 |
|
|
|
|
Test item | 0.10mg | 33 | 36 | 3 | 28 | 24 | 4 | 1.0 | 0.7 |
|
| 38 |
|
| 21 |
|
|
|
|
|
| 37 |
|
| 23 |
|
|
|
|
| 0.25mg | 41 | 43 | 4 | 20 | 25 | 4 | 1.2 | 0.7 |
|
| 40 |
|
| 28 |
|
|
|
|
|
| 48 |
|
| 26 |
|
|
|
|
| 0.50mg | 30 | 37 | 6 | 25 | 27 | 8 | 1.0 | 0.8 |
|
| 40 |
|
| 20 |
|
|
|
|
|
| 40 |
|
| 35 |
|
|
|
|
| 1.0mg | 45 mP | 36 | 8 | 22 mP | 24 | 2 | 1.0 | 0.7 |
|
| 29 mP |
|
| 26 mP |
|
|
|
|
|
| 33 mP |
|
| 25 mP |
|
|
|
|
| 2.5mg | 41 mP | 38 | 5 | 25 mP | 21 | 3 | 1.1 | 0.6 |
|
| 33 mP |
|
| 19 mP |
|
|
|
|
|
| 41 mP |
|
| 20 mP |
|
|
|
|
| 5.0mg | 34 mPB | 38 | 5 | 25 mPB | 22 | 4 | 1.1 | 0.6 |
|
| 37 mPB |
|
| 17 mPB |
|
|
|
|
|
| 43 mPB |
|
| 24 mPB |
|
|
|
|
2-AA | 5.0 µg | 47 | 53 | 6 | 1770 | 1805 | 57 | 1.5 | 53.1 |
|
| 59 |
|
| 1871 |
|
|
|
|
|
| 54 |
|
| 1775 |
|
|
|
|
B[a]P | 2.5 µg | 42 | 42 | 4 | 280 | 265 | 21 | 1.2 | 7.8 |
|
| 45 |
|
| 241 |
|
|
|
|
|
| 38 |
|
| 273 |
|
|
|
|
2-NF | 10µg | 726 | 760 | 37 | 318 | 373 | 56 | 21.7 | 11.0 |
|
| 753 |
|
| 430 |
|
|
|
|
|
| 800 |
|
| 371 |
|
|
|
|
M : Mean SD : Standard-deviation Quotient = Mean revertants (test substance) p : Precipitation +S9 : With S9 mix -S9 : Without S9 mix m :-Manually scored C : Contamination / : Not tested B : Background lawn reduced R : Repeat experiment |
Applicant's summary and conclusion
- Conclusions:
- The mutagenic potential of the test substance was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in the presence and absence of S9 mix according to OECD TG 471. Evidence of mutagenic activity was not seen up to the maximum recommended dose level of 5.0 mg/plate. No substantial increases in revertant colony numbers of any of the five tester strains were observed at any dose level in the presence and absence of metabolic activation. Therefore, ZK 47525 (fluocortolone-A-acetate) was considered to be non-mutagenic in the Salmonella typhimurium reverse mutation assay.
- Executive summary:
In a reverse gene mutation assay in bacteria according to OECD test guideline 471, strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 of S. typhimurium were exposed to Fluocortolone acetate (100% a.i.), in DMSO at concentrations of 0.1, 0.25, 0.5, 1.0, 2.5, 5.0 mg/plate in the presence and absence of mammalian metabolic activation with the plate co-incubation method.
Fluocortolone acetate was tested up to cytotoxic and insoluble concentrations. None of the five tester strains TA 1535, TA 100, TA 1537, TA 1538 and TA98 showed increased reversion to prototrophy in assays with ZK 47525 at the doses tested between 0.1 and·5.0 mg/plate, either in the absence or presence of S9 mix. In the present study ZK 47525 was tested up to the highest recommended dose of 5 mg/plate. Precipitates in the agar were found starting at 1.0 mg/plate onwards. Growth inhibition of the background lawn was observed at the highest dose tested. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.
This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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