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EC number: 410-070-8 | CAS number: 141880-36-6 ACID RED HT 3728; ERIONYL RED HT 3728
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 October 2013 to 04 December 2013
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Details on test material:
- Name: FAT 45155/E TE
Batch No.: BS-DUW 1120/004-01
Physical State at RT: solid (powder)
Colour: red in fine grained form; greenish black in coarse-grained form
Density: 1.74 (relative)
Active components: 74.4%
Expiry Date: 15 August 2018
Storage Conditions: at room temperature
Constituent 1
- Specific details on test material used for the study:
- Name: FAT 45155/E TE
Batch No.: BS-DUW 1120/004-01
Physical State at RT: solid (powder)
Colour: red in fine grained form; greenish black in coarse- grained form
Density: 1.74 (relative)
Active components: 74.4 %
Expiry Date: 15 August 2018
Storage Conditions: at room temperature
Method
- Target gene:
- hypoxanthine-guanine-phosphoribosyl-transferase (HPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- -Type and identity of media: MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 of Wistar Phenobarbital and ß-Naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-experiment for experiment I (with and without metabolic activation):
25, 50, 100, 250, 500, 1000, 1750, 2500, 3750, 5000 µg/mL
Pre-experiment for experiment II (only without metabolic activation, 20 h long-term exposure assay):
25, 50, 100, 250, 500, 1000, 1750, 2500, 3750, 5000 µg/mL
Experiment I
without metabolic activation: 7.4, 18.6, 37.2, 74.4, 186.0, 372.0, 446.4 and 520.8 µg/mL
and with metabolic activation: 25, 50, 100, 250, 500, 1000, 1750, 2500, 3750 and 5000 µg/mL
Experiment II
without metabolic activation: 50, 100, 200, 400, 600, 800, 1000, 1200, 1800 and 2000 µg/mL
and with metabolic activation: 35, 70, 150, 300, 600, 800, 1000, 4000 and 5000 µg/mL - Vehicle / solvent:
- Vehicle (Solvent) used: cell culture medium (MEM + 0 % FBS 4h treatment; MEM + 10 % FBS 20h treatment).
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation; 300 µg/mL
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- with metabolic activation; 0.8 and 1.0 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: dissolved in medium
DURATION: 4 h (short-term exposure), 20 h (long-term exposure)
Expression time (cells in growth medium): 5 days
Selection time (if incubation with selection agent): about one week
SELECTION AGENT (mutation assay): rate experiments (I+II) with single exposure; 5 individual flasks were seeded and evaluated
NUMBER OF CELLS EVALUATED: 400000 cells per flask
DETERMINATION OF CYTOTOXICITY: Method: relative growth
Cells:
V79 cells in vitro have been widely used to examine the ability of chemicals to induce cytogenetic changes and thus identify potential carcinogens or mutagens. These cells are characterized by their high proliferation rate (12 - 14 h doubling time of the BSL BIOSERVICE stock cultures) and their high cloning efficiency of untreated cells, usually more than 50 %. These facts are necessary for the appropriate performance of the study. The V79 cells (ATCC, CCL-93) were stored over liquid nitrogen (vapour phase) in the cell bank of BSL BIOSERVICE. This allows the repeated use of the same cell culture batch in experiments. Each cell batch was routinely checked for mycoplasma infections (PCR). Thawed stock cultures were maintained in plastic culture flasks in minimal essential medium (MEM). For purifying the cell population of pre-existing HPRT- mutants cells were exposed to HAT medium containing 100 µM hypoxanthine, 0.4 µM aminopterin, 16 µM thymidine and 10.0 µM glycine for several cell doublings (2-3 days). - Evaluation criteria:
- A test is considered to be negative if there is no biologically relevant increase in the number of mutants.
There are several criteria for determining a positive result:
-a reproducible three times higher mutation frequency than the solvent control for at least one of the concentrations;
-a concentration related increase of the mutation frequency; such an evaluation may be considered also in the case that a three-fold increase of
the mutant frequency is not observed;
-if there is by chance a low spontaneous mutation rate in the corresponding negative and solvent controls a concentration related increase of the mutations within their range has to be discussed.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I without S9: ≥186.0 μg/mL and at 7.4 µg/mL; experiment I with S9: ≥1750 μg/mL and at 500 µg/mL; Experiment II without S9: ≥600 μg/mL; Experiment II with S9: ≥300 μg/mL
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Precipitation:
No precipitation of the test item was noted in any of the experiments.
Toxicity:
A biologically relevant growth inhibition (reduction of relative growth below 70 %) was observed after the treatment with the test item in experiment I and II with and without metabolic activation.
In experiment I without metabolic activation the relative growth was 11.2 % for the highest concentration (520.8 µg/mL) evaluated. The highest biologically relevant concentration evaluated with metabolic activation was 5000 µg/mL with a relative growth of 21.6 %. In experiment II without metabolic activation the relative growth was 10.2 % for the highest concentration (2000 µg/mL) evaluated. The highest concentration evaluated with metabolic activation was 5000 µg/mL with a relative growth of 19.2 %.
Mutagenicity:
In experiment I without metabolic activation all mutant values of the negative controls and test item concentrations found were within the historical control data of the test facility BSL BIOSERVICE (about 5-43 mutants per 106 cells). No dose-response relationship could be observed. The mutation frequencies found in the groups treated with the test item did not show a biologically relevant increase as compared to the negative controls. Mutation frequencies with the negative control were found to be 11.91 and 16.72 mutants/106 cells and in the range of 6.41 to 33.33 mutants/106 cells with the test item, respectively. The highest mutation rate (compared to the negative control values) of 2.33 was found at a concentration of 74.4 µg/mL with a relative growth of 76.2 %. With metabolic activation all mutant values of the negative controls and test item concentrations found were within the historical control data of the test facility BSL BIOSERVICE (about 5-44 mutants per 106 cells). No dose-response relationship could be observed. The mutation frequencies found in the groups treated with the test item did not show a biologically relevant increase as compared to the negative controls. Mutation frequencies with the negative control were found to be 37.99 and 24.93 mutants/106 cells and in the range of 13.85 to 43.30 mutants/106 cells with the test item, respectively. The highest mutation rate (compared to the negative control values) of 1.38 was found at a concentration of 1750 µg/mL with a relative growth of 34.3%. In experiment II without metabolic activation most mutant values of the negative controls and test item concentrations found were within the historical control data of the test facility BSL BIOSERVICE (about 5-43 mutants per 106 cells). No dose-response relationship could be observed. The mutation frequencies found in the groups treated with the test item did not show a biologically relevant increase as compared to the negative controls. Mutation frequencies with the negative control were found to be 22.63 and 25.81 mutants/106 cells and in the range of 15.05 to 58.90 mutants/106 cells with the test item, respectively. The highest mutation rate (compared to the negative control values) of 2.43 was found at a concentration of 100 µg/mL with a relative growth of 72.8 %. In experiment II with metabolic activation most mutant values of the negative controls and test item concentrations found were within the historical control data of the test facility BSL BIOSERVICE (about 5-44 mutants per 106 cells). No dose-response relationship could be observed. The mutation frequencies found in the groups treated with the test item did not show a biologically relevant increase as compared to the negative controls. Mutation frequencies with the negative control were found to be 33.23 and 20.60 mutants/106 cells and in the range of 7.50 to 63.07 mutants/106 cells with the test item, respectively. The highest mutation rate (compared to the negative control values) of 2.34 was found at a concentration of 600 µg/mL with a relative growth of 19.3 %. DMBA (0.8 and 1.0 µg/mL) and EMS (300 µg/mL) were used as positive controls and showed distinct and biologically relevant effects in mutation frequency.
Experiment I -Toxicity, without metabolic activation
Dose Group | Concen-tration[µg/mL] | Cell Density[cells/mL]a | Relative Growth[%]a | Number of cells per flaskb | Cloning Efficiency[%] | ||
I | II | mean | |||||
NC1 |
0 | 891000 |
100.0 | 143 | 176 | 160 | 80 |
NC2 | 889000 | 141 | 146 | 144 | 72 | ||
1 | 7.4 | 512000 | 57.5 | 143 | 144 | 144 | 72 |
2 | 18.6 | 641000 | 72.0 | 141 | 151 | 146 | 73 |
3 | 37.2 | 671000 | 75.4 | 152 | 174 | 163 | 82 |
4 | 74.4 | 678000 | 76.2 | 171 | 177 | 174 | 87 |
5 | 186.0 | 441000 | 49.6 | 155 | 162 | 159 | 79 |
6 | 372.0 | 194000 | 21.8 | 148 | 157 | 153 | 76 |
7 | 446.4 | 127000 | 14.3 | 142 | 150 | 146 | 73 |
8 | 520.8 | 100000 | 11.2 | 147 | 165 | 156 | 78 |
EMS | 300 | 793000 | 89.1 | 135 | 137 | 136 | 68 |
NC: negative control/medium control
a: cell density and relative growth at 1st subcultivation
b: mean value of cells per flask/200
EMS: Ethyl methane sulfonate[300µg/ml]
Experiment I– Mutagenicity, without metabolic activation
Dose Group | Concen-tration[µg/mL] | Number of mutant colonies per flaska |
Mean |
SD | Mutant colonies per 106cellsb |
Mutation Factor | ||||
I | II | III | IV | V | ||||||
NC1 |
0 | 4 | 4 | 2 | 5 | 4 | 3.8 | 0.98 | 11.91 |
|
NC2 | 3 | 3 | 5 | 6 | 7 | 4.8 | 1.60 | 16.72 | ||
1 | 7.4 | 6 | 7 | 9 | 10 | 11 | 8.6 | 1.85 | 29.97 | 2.09 |
2 | 18.6 | 4 | 5 | 5 | 5 | 7 | 5.2 | 0.98 | 17.81 | 1.24 |
3 | 37.2 | 1 | 2 | 4 | 5 | 6 | 3.6 | 1.85 | 11.04 | 0.77 |
4 | 74.4 | 10 | 9 | 13 | 12 | 14 | 11.6 | 1.85 | 33.33 | 2.33 |
5 | 186.0 | 2 | 3 | 3 | 4 | 4 | 3.2 | 0.75 | 10.09 | 0.71 |
6 | 372.0 | 3 | 3 | 4 | 5 | 6 | 4.2 | 1.17 | 13.77 | 0.96 |
7 | 446.4 | 9 | 9 | 10 | 10 | 10 | 9.6 | 0.49 | 32.88 | 2.30 |
8 | 520.8 | 1 | 1 | 2 | 3 | 3 | 2.0 | 0.89 | 6.41 | 0.45 |
EMS | 300 | 80 | 86 | 89 | 96 | 109 | 92.0 | 9.94 | 338.24 | 23.62 |
NC: negative control/medium control
a: number of mutant colonies in flask I toV
b: mean mutant colonies x 106/ (400000 x Cloning Efficiency/100)
EMS: Ethylmethanesulfonate [300 µg/ml]
Experiment I- Toxicity, with metabolic activation
Dose Group | Concen-tration[µg/ml] | Cell Density[cells/ml]a | Relative Growth[%]a | Number of cells per flaskb | Cloning Efficiency[%] | ||
I | II | mean | |||||
NC1 |
0 | 1230000 | 100.8 | 189 | 190 | 190 | 95 |
NC2 | 1210000 | 99.2 | 149 | 188 | 169 | 84 | |
1 | 25 | 1270000 | 104.1 | 207 | 220 | 214 | 107 |
2 | 50 | 1180000 | 96.7 | 181 | 208 | 195 | 97 |
3 | 100 | 1110000 | 91.0 | 218 | 193 | 206 | 103 |
4 | 250 | 1180000 | 96.7 | 209 | 216 | 213 | 106 |
5 | 500 | 632000 | 51.8 | 214 | 177 | 196 | 98 |
6 | 1000 | 855000 | 70.1 | 209 | 215 | 212 | 106 |
7 | 1750 | 418000 | 34.3 | 193 | 195 | 194 | 97 |
8 | 2500 | 258000 | 21.1 | 185 | 198 | 192 | 96 |
9 | 3750 | 198000 | 16.2 | 187 | 197 | 192 | 96 |
10 | 5000 | 263000 | 21.6 | 201 | 189 | 195 | 98 |
DMBA | 0.8 | 894000 | 73.3 | 157 | 162 | 160 | 80 |
DMBA | 1.0 | 881000 | 72.2 | 162 | 182 | 172 | 86 |
NC: negative control/medium control
a: cell density and relative growth at 1st subcultivation
b: mean value of cells per flask/200
DMBA: 7,12-Dimethylbenz(a)anthracene[0.8 and 1.0 µg/mL]
Experiment I– Mutagenicity, with metabolic activation
Dose Group | Concen-tration[µg/ml] | Number of mutant colonies per flaska |
Mean |
SD | Mutant colonies per 106cellsb |
Mutation Factor | ||||
I | II | III | IV | V | ||||||
NC1 |
0 | 17 | 20 | 10 | 14 | 11 | 14.4 | 3.72 | 37.99 |
|
NC2 | 5 | 11 | 11 | 6 | 9 | 8.4 | 2.50 | 24.93 | ||
1 | 25 | 13 | 15 | 15 | 16 | 25 | 16.8 | 4.21 | 39.34 | 1.25 |
2 | 50 | 11 | 13 | 14 | 17 | 18 | 14.6 | 2.58 | 37.53 | 1.19 |
3 | 100 | 10 | 12 | 13 | 14 | 16 | 13.0 | 2.00 | 31.63 | 1.01 |
4 | 250 | 8 | 8 | 8 | 8 | 9 | 8.2 | 0.40 | 19.29 | 0.61 |
5 | 500 | 7 | 7 | 9 | 9 | 13 | 9.0 | 2.19 | 23.02 | 0.73 |
6 | 1000 | 11 | 14 | 14 | 15 | 23 | 15.4 | 4.03 | 36.32 | 1.15 |
7 | 1750 | 14 | 21 | 15 | 15 | 19 | 16.8 | 2.71 | 43.30 | 1.38 |
8 | 2500 | 6 | 7 | 8 | 9 | 12 | 8.4 | 2.06 | 21.93 | 0.70 |
9 | 3750 | 16 | 16 | 16 | 17 | 18 | 16.6 | 0.80 | 43.23 | 1.37 |
10 | 5000 | 4 | 5 | 5 | 6 | 7 | 5.4 | 1.02 | 13.85 | 0.44 |
DMBA | 0.8 | 40 | 28 | 27 | 34 | 34 | 32.6 | 4.72 | 102.19 | 3.25 |
DMBA | 1.0 | 37 | 38 | 32 | 32 | 33 | 34.4 | 2.58 | 100.00 | 3.18 |
NC: negative control/medium control
a: number of mutant colonies in flask I to V
b: mean mutant colonies x 106/ (400000 x Cloning Efficiency/100)
DMBA: 7,12-Dimethylbenz(a)anthracene [0.8 and 1.0µg/mL]
Experiment II -Toxicity, without metabolic activation
Dose Group | Concen-tration [µg/mL] | Cell Density [cells/mL]a | Relative Growth [%]a | Number of cells per flaskb | Cloning Efficiency [%] | ||
I | II | mean | |||||
NC1 |
0 | 1890000 |
100.0 | 196 | 184 | 190 | 95 |
NC2 | 1820000 | 199 | 204 | 202 | 101 | ||
3 | 50 | 1510000 | 81.4 | 158 | 161 | 160 | 80 |
4 | 100 | 1350000 | 72.8 | 152 | 157 | 155 | 77 |
5 | 200 | 1830000 | 98.7 | 169 | 169 | 169 | 85 |
6 | 400 | 1310000 | 70.6 | 174 | 195 | 185 | 92 |
7 | 600 | 1060000 | 57.1 | 190 | 196 | 193 | 97 |
8 | 800 | 1020000 | 55.0 | 163 | 175 | 169 | 85 |
9 | 1000 | 805000 | 43.4 | 200 | 174 | 187 | 94 |
10 | 1200 | 574000 | 30.9 | 176 | 153 | 165 | 82 |
13 | 1800 | 142000 | 7.7 | 191 | 173 | 182 | 91 |
14 | 2000 | 189000 | 10.2 | 150 | 136 | 143 | 72 |
EMS | 300 | 1490000 | 80.3 | 126 | 164 | 145 | 73 |
NC:negative control/medium control
a: cell density and relative growth at 1st subcultivation
b: mean value of cells per flask /200
EMS: Ethylmethanesulfonate[300µg/ml]
Experiment II–Mutagenicity, without metabolic activation
Dose Group | Concen-tration [µg/mL] | Number of mutant colonies per flaska |
Mean |
SD | Mutant colonies per 106 cellsb |
Mutation Factor | ||||
I | II | III | IV | V | ||||||
NC1 |
0 | 5 | 6 | 8 | 11 | 13 | 8.6 | 3.01 | 22.63 |
|
NC2 | 6 | 8 | 10 | 11 | 17 | 10.4 | 3.72 | 25.81 | ||
3 | 50 | 2 | 3 | 4 | 7 | 8 | 4.8 | 2.32 | 15.05 | 0.62 |
4 | 100 | 12 | 16 | 18 | 22 | 23 | 18.2 | 4.02 | 58.90 | 2.43 |
5 | 200 | 10 | 11 | 11 | 11 | 15 | 11.6 | 1.74 | 34.32 | 1.42 |
6 | 400 | 5 | 12 | 13 | 14 | 15 | 11.8 | 3.54 | 31.98 | 1.32 |
7 | 600 | 3 | 4 | 4 | 6 | 8 | 5.0 | 1.79 | 12.95 | 0.53 |
8 | 800 | 5 | 6 | 6 | 8 | 8 | 6.6 | 1.20 | 19.53 | 0.81 |
9 | 1000 | 4 | 6 | 8 | 9 | 11 | 7.6 | 2.42 | 20.32 | 0.84 |
10 | 1200 | 6 | 7 | 9 | 13 | 14 | 9.8 | 3.19 | 29.79 | 1.23 |
13 | 1800 | 6 | 7 | 10 | 11 | 15 | 9.8 | 3.19 | 26.92 | 1.11 |
14 | 2000 | 8 | 9 | 10 | 10 | 12 | 9.8 | 1.33 | 34.27 | 1.41 |
EMS | 300 | 228 | 200 | 217 | 184 | 237 | 213.2 | 19.11 | 735.17 | 30.36 |
NC: negative control/medium control
a: number of mutant colonies in flask I to V
b: mean mutant colonies x 106/ (400000 x Cloning Efficiency/100)
EMS: Ethylmethanesulfonate [300µg/ml]
Experiment II-Toxicity, with metabolic activation
Dose Group | Concen-tration [µg/mL] | Cell Density [cells/mL]a | Relative Growth [%]a | Number of cells per flaskb | Cloning Efficiency [%] | ||
I | II | mean | |||||
NC1 |
0 | 995000 |
100.0 | 157 | 168 | 163 | 81 |
NC2 | 902000 | 192 | 177 | 185 | 92 | ||
4 | 35 | 869000 | 91.6 | 186 | 179 | 183 | 91 |
5 | 70 | 961000 | 101.3 | 178 | 189 | 184 | 92 |
6 | 150 | 735000 | 77.5 | 182 | 186 | 184 | 92 |
7 | 300 | 510000 | 53.8 | 163 | 174 | 169 | 84 |
8 | 600 | 183000 | 19.3 | 191 | 180 | 186 | 93 |
9 | 800 | 170000 | 17.9 | 169 | 171 | 170 | 85 |
10 | 1000 | 123000 | 13.0 | 180 | 181 | 181 | 90 |
13 | 4000 | 95100 | 10.0 | 150 | 170 | 160 | 80 |
14 | 5000 | 182000 | 19.2 | 194 | 197 | 196 | 98 |
DMBA | 0.8 | 614000 | 64.7 | 167 | 170 | 169 | 84 |
DMBA | 1.0 | 612000 | 64.5 | 175 | 189 | 182 | 91 |
NC: negative control/medium control
a: cell density and relative growth at 1st subcultivation
b: mean value of cells per flask/200
DMBA: 7,12-Dimethylbenz(a)anthracene[0.8and1.0µg/mL]
Experiment II–Mutagenicity, with metabolic activation
Dose Group | Concen-tration [µg/mL] | Number of mutant colonies per flaska |
Mean |
SD | Mutant colonies per 106 cellsb |
Mutation Factor | ||||
I | II | III | IV | V | ||||||
NC1 | 0 | 9 | 11 | 11 | 11 | 12 | 10.8 | 0.98 | 33.23 |
|
NC2 | 5 | 7 | 7 | 8 | 11 | 7.6 | 1.96 | 20.60 | ||
4 | 35 | 3 | 4 | 4 | 10 | 11 | 6.4 | 3.38 | 17.53 | 0.65 |
5 | 70 | 7 | 9 | 9 | 10 | 14 | 9.8 | 2.32 | 26.70 | 0.99 |
6 | 150 | 7 | 9 | 9 | 10 | 19 | 10.8 | 4.21 | 29.35 | 1.09 |
7 | 300 | 6 | 7 | 8 | 9 | 13 | 8.6 | 2.42 | 25.52 | 0.95 |
8 | 600 | 15 | 23 | 23 | 25 | 31 | 23.4 | 5.12 | 63.07 | 2.34 |
9 | 800 | 4 | 4 | 4 | 5 | 6 | 4.6 | 0.80 | 13.53 | 0.50 |
10 | 1000 | 12 | 15 | 16 | 18 | 20 | 16.2 | 2.71 | 44.88 | 1.67 |
13 | 4000 | 0 | 2 | 3 | 3 | 4 | 2.4 | 1.36 | 7.50 | 0.28 |
14 | 5000 | 6 | 6 | 7 | 9 | 10 | 7.6 | 1.62 | 19.44 | 0.72 |
DMBA | 0.8 | 109 | 121 | 124 | 131 | 133 | 123.6 | 8.52 | 366.77 | 13.63 |
DMBA | 1.0 | 132 | 133 | 134 | 139 | 147 | 137.0 | 5.55 | 376.37 | 13.98 |
NC: negative control/medium control
a: number of mutant colonies in flask I to V
b: mean mutant colonies x 106/ (400000 x Cloning Efficiency/100)
DMBA: 7,12-Dimethylbenz(a)anthracene[0.8 and 1.0µg/mL]
Applicant's summary and conclusion
- Conclusions:
- FAT 45155/E is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.
- Executive summary:
In a GLP compliant study conducted according to OECD guideline 476 and EU method B.17, FAT 45155/E was assessed for its potential to induce mutations at the HPRT locus using V79 cells of the Chinese Hamster. The selection of the concentrations was based on data from the pre-experiments. Experiment I with and without metabolic activation and experiment II with metabolic activation were performed as a 4 h short-term exposure assay. Experiment II without metabolic activation was performed as 20 h long time exposure assay. The test item was investigated at the following concentrations:
Experiment I
without metabolic activation: 7.4, 18.6, 37.2, 74.4, 186.0, 372.0, 446.4 and 520.8 µg/mL and with metabolic activation: 25, 50, 100, 250, 500, 1000, 1750, 2500, 3750 and 5000 µg/mL
Experiment II without metabolic activation: 50, 100, 200, 400, 600, 800, 1000, 1200, 1800 and 2000 µg/mL and with metabolic activation: 35, 70, 150, 300, 600, 800, 1000, 4000 and 5000 µg/mL
No precipitation of the test item was noted in the experiments. Biologically relevant growth inhibition was observed in experiment I and II with and without metabolic activation. In experiment I without metabolic activation the relative growth was 11.2 % for the highest concentration (520.8 µg/mL) evaluated. The highest biologically relevant concentration evaluated with metabolic activation was 5000 µg/mL with a relative growth of 21.6 %. In experiment II without metabolic activation the relative growth was 10.2 % for the highest concentration (2000 µg/mL) evaluated. The highest concentration evaluated with metabolic activation was 5000 µg/mL with a relative growth of 19.2 %. In both experiments no biologically relevant increase of mutants was found after treatment with the test item (with and without metabolic activation). No dose-response relationship was observed. DMBA and EMS were used as positive controls and showed distinct and biologically relevant effects in mutation frequency. In conclusion, FAT 45155/E is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.
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