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EC number: 500-241-6 | CAS number: 69011-36-5 1 - 2.5 moles ethoxylated
- 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 cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 May - 10 Oct 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- Version / remarks:
- adopted in 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Isotridecanol, ethoxylated
- EC Number:
- 500-241-6
- EC Name:
- Isotridecanol, ethoxylated
- Cas Number:
- 69011-36-5
- Molecular formula:
- not available, isomeric structures
- IUPAC Name:
- Isotridecanol, ethoxylated
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- lymphocytes: cultured peripheral human lymphocytes
- Details on mammalian cell type (if applicable):
- CELLS USED
For lymphocytes:
- Sex, age and number of blood donors: Female, 35 and 33 years, two (Main Assay I); female, 27 and 28 years, two (Main Assay II); male, 30 years, one (Main Assay III)
- Whether whole blood or separated lymphocytes were used: whole blood
- Whether blood from different donors were pooled or not: pooled (Main Assays I and II), not pooled (Main Assay III)
- Mitogen used for lymphocytes: phytohaemagglutinin (PHA)
MEDIA USED
- Type and composition of media:
Culture medium:
RPMI 1640 1x (Dutch modification): 500 mL
Foetal Calf Serum (FCS): 100 mL
L-Glutamine (200 mM): 6.25 mL
Antibiotic solution (not further specified): 1.25 mL
Treatment medium (3 h exposure):
+S9:
Test item solution or solvent/vehicle: 0.05 mL
S9 mix: 1.00 mL
Culture medium (without PHA): 3.95 mL
-S9:
Test item solution or solvent/vehicle: 0.05 mL
Culture medium (without PHA): 4.95 mL
Treatment medium (continous exposure):
Test item as supplied, test item solution or solvent/vehicle: 0.025 mL
Culture medium (without PHA): 4.975 mL
- Cytokinesis block (if used):
- Cytochalasin B (6 μg/mL)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and 5,6-benzoflavone.
- Species: rat
- Strain: Sprague Dawley
- Sex: male
- Age: 5 - 6 weeks
- Weight: 175 - 199 g
- Tissue: liver
- Inducing Agents: phenobarbital and 5,6-benzoflavone
- Producer: TRINOVA BIOCHEM GmbH, Giessen, Germany
- Batch Number: 3971
- Quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): yes - Test concentrations with justification for top dose:
- Main Assay I:
3 h exposure (with and without metabolic activation): 0.195, 0.293, 0.439, 0.658, 0.988, 1.48, 2.22, 3.33, 5.00 μL/mL
31 h exposure (without metabolic activation): 0.130, 0.195, 0.293, 0.439, 0.658, 0.988, 1.48, 2.22, 3.33, 5.00 μL/mL
Haemolysis was observed at all doses in all experiments.
Main Assay II:
3 h exposure (with and without metabolic activation): 0.00780, 0.0117, 0.0176, 0.0263, 0.0395, 0.0593, 0.0889, 0.133, 0.200 µL/mL
31 h exposure (without metabolic activation): 0.000520, 0.000780, 0.00117, 0.00176, 0.00263, 0.00395, 0.00593, 0.00889, 0.0133, 0.0200 µL/mL
Cytotoxicity was observed in the 3 h experiments in the presence of metabolic activation.
Main Assay III:
3 h exposure (with metabolic activation): 0.0654, 0.0752, 0.0865, 0.0994, 0.114, 0.132, 0.151, 0.174, 0.200 µL/mL - Vehicle / solvent:
- - Vehicle/solvent used: dimethylsulfoxide (DMSO)
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water, DMSO was selected as the vehicle. This vehicle was selected since it is compatible with the survival of cells and the S9 metabolic activation system.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- colchicine
- cyclophosphamide
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: duplicate
- Number of independent experiments : three
METHOD OF TREATMENT/ EXPOSURE:
- Test material added in medium
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 48 h
- Exposure duration/duration of treatment: 3 h (3 h exposure experiments) and 31 h (continous exposure experiments)
- Harvest time after the end of treatment (sampling/recovery times): 32 h in 3 h exposure experiments and 31 h in continous exposure experiments
FOR CHROMOSOME ABERRATION AND MICRONUCLEUS:
- If cytokinesis blocked method was used for micronucleus assay: cytB 6 µL/mL medium, added 3 h after start of treatment
- Methods of slide preparation and staining technique used including the stain used: The lymphocyte cultures were centrifuged and the supernatant was removed. The cells were resuspended in hypotonic solution and fresh methanol/acetic acid fixative was added. The fixative was changed several times by centrifugation and resuspension. A few drops of the cell suspension were transfered to glass slides which were allowed to air dry before staining with acridine Orange in phosphate buffered saline (PBS).
- Number of cells spread and analysed per concentration (number of replicate cultures and total number of cells scored): 2000 binucleated cells per cell culture were scored
- Criteria for scoring micronucleated cells (selection of analysable cells and micronucleus identification):
1. The micronucleus diameter was less than 1/3 of the nucleus diameter
2. The micronucleus diameter was greater than 1/16 of the nucleus diameter
3. No overlapping with the nucleus was observed
4. The aspect was the same as the chromatin
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: cytokinesis-block proliferation index (CBPI), 1000 cells counted per concentration - Evaluation criteria:
- EVALUATION CRITERIA
A test item is considered clearly positive if the following criteria are met:
1. Significant increases in the proportion of micronucleated cells over the concurrent controls occur at one or more concentrations.
2. The proportion of micronucleated cells at such data points exceeds the normal range based on historical control values (95% control limits).
3. There is a significant dose-effect relationship.
A item is considered clearly negative if the following criteria are met:
1. None of the dose levels shows a statistically significant increase in the incidence of micronucleated cells.
2. There is no concentration-related increase when evaluated with the Cochran-Armitage trend test.
3. All the results are inside the distribution of the historical control data (95% control limits).
ACCEPTANCE CRITERIA
The assay is considered valid if the following criteria are met:
1. The incidence of micronucleated cells of the negative control is within the distribution range of our historical control values.
2. Concurrent positive controls induce responses that are compatible with those generated in our historical positive control database and produce a statistically significant increase compared with the concurrent negative control.
3. Adequate cell proliferation is observed in solvent control cultures.
4. The appropriate number of doses and cells is analysed. - Statistics:
- A modified χ2 test was used to compare the number of cells with micronuclei in control and treated cultures.
Cochran-Armitage Trend Test (one-sided) was performed for the assessment of the concentration-response relationship.
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: cultured peripheral human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Strong cytotoxicity was observed at and above 0.130 μL/mL in the absence and presence of metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Data on pH: Treatment with the test item did not change the pH at any dose level in any experiment.
- Data on osmolality: Treatment with the test item did not increases the osmolality at any dose level in any experiment.
- Precipitation and time of the determination: Following treatment with the test item, no opacity or precipitation of the medium was observed at the beginning or by the end of treatment in any experiment.
STUDY RESULTS
- Concurrent vehicle negative and positive control data are reported in tabular form under 'Any other information on results incl. tables'.
HISTORICAL CONTROL DATA
- The incidence of micronucleated cells of the negative controls was within the distribution range of our historical control values, data are presented in tabular form under 'Any other information on results incl. tables'.
Any other information on results incl. tables
Table 1: Proliferation index
Main Assay I | ||||||||
Treatment (µL/mL) | Culture No. | MonoN | BiN | PoliN | Total cells | CBPI | Mean Value | Cytotoxicity (%) |
Treatment: 3 h, - S9 | ||||||||
Test Item* | 19 | Only mononucleated cells | ||||||
0.195 | 20 | |||||||
Treatment: 3 h, +S9 | ||||||||
Solvent* | 21 | 124 | 219 | 157 | 500 | 2.066 | 2.052 | 0 |
1% | 22 | 123 | 235 | 142 | 500 | 2.038 | ||
Test Item* | 39 | 378 | 122 | 0 | 500 | 1.244 | 1.235 | 78 |
0.195 | 40 | 388 | 111 | 1 | 500 | 1.226 | ||
Test Item* | 37 | Only mononucleated cells | ||||||
0.293 | 38 | |||||||
Test Item* | 35 | Only mononucleated cells | ||||||
0.439 | 36 | |||||||
Treatment: 31 h, - S9 | ||||||||
Test Item* | 65 | Only mononucleated cells | ||||||
0.130 | 66 | |||||||
Main Assay II | ||||||||
Treatment (µL/mL) | Culture No. | MonoN | BiN | PoliN | Total cells | CBPI | Mean Value | Cytotoxicity (%) |
Treatment: 3 h, -S9 | ||||||||
Solvent* | 71 | 122 | 275 | 103 | 500 | 1.962 | 1.953 | 0 |
1% | 72 | 138 | 252 | 110 | 500 | 1.944 | ||
Test Item* | 85 | 121 | 256 | 123 | 500 | 2.004 | 1.983 | -3 |
0.0176 | 86 | 143 | 233 | 124 | 500 | 1.962 | ||
Test Item* | 83 | 123 | 274 | 103 | 500 | 1.960 | 1.925 | 3 |
0.0263 | 84 | 155 | 245 | 100 | 500 | 1.890 | ||
Test Item* | 81 | 154 | 248 | 98 | 500 | 1.888 | 1.897 | 6 |
0.0395 | 82 | 139 | 269 | 92 | 500 | 1.906 | ||
Test Item* | 79 | 120 | 294 | 86 | 500 | 1.932 | 1.878 | 8 |
0.0593 | 80 | 154 | 280 | 66 | 500 | 1.824 | ||
Test Item* | 77 | 305 | 177 | 18 | 500 | 1.426 | 1.445 | 53 |
0.0889 | 78 | 289 | 190 | 21 | 500 | 1.464 | ||
Test Item* | 75 | Very few mononucleated cells recovered onto slides | ||||||
0.133 | 76 | |||||||
Test Item* | 73 | No cells recovered onto slides | ||||||
0.200 | 74 | |||||||
Treatment: 3 h, +S9 | ||||||||
Solvent* | 91 | 144 | 217 | 139 | 500 | 1.990 | 1.802 | 0 |
1% | 92 | 243 | 207 | 50 | 500 | 1.614 | ||
Test Item* | 103 | 165 | 211 | 124 | 500 | 1.918 | 1.911 | -14 |
0.0263 | 104 | 166 | 216 | 118 | 500 | 1.904 | ||
Test Item* | 101 | 162 | 249 | 89 | 500 | 1.854 | 1.857 | -7 |
0.0395 | 102 | 169 | 232 | 99 | 500 | 1.860 | ||
Test Item* | 99 | 154 | 242 | 104 | 500 | 1.900 | 1.832 | -4 |
0.0593 | 100 | 204 | 210 | 86 | 500 | 1.764 | ||
Test Item* | 97 | 179 | 237 | 84 | 500 | 1.810 | 1.861 | -7 |
0.0889 | 98 | 134 | 276 | 90 | 500 | 1.912 | ||
Test Item* | 95 | 276 | 209 | 15 | 500 | 1.478 | 1.469 | 42 |
0.133 | 96 | 290 | 190 | 20 | 500 | 1.460 | ||
Test Item* | 93 | Very few mononucleated cells recovered onto slides | ||||||
0.200 | 94 | |||||||
Cyclophosphamide | 111 | 310 | 182 | 8 | 500 | 1.396 | 1.394 | 51 |
20.0 µg/mL | 112 | 311 | 182 | 7 | 500 | 1.392 | ||
Cyclophosphamide | 113 | 316 | 176 | 8 | 500 | 1.384 | 1.392 | 51 |
15.0 µg/mL | 114 | 306 | 188 | 6 | 500 | 1.400 | ||
Treatment: 31 h, - S9 | ||||||||
Solvent* | 115 | 118 | 273 | 109 | 500 | 1.982 | 1.951 | 0 |
0.5% | 116 | 140 | 260 | 100 | 500 | 1.920 | ||
Test Item* | 129 | 172 | 266 | 62 | 500 | 1.780 | 1.796 | 16 |
0.00176 | 130 | 164 | 266 | 70 | 500 | 1.812 | ||
Test Item* | 127 | 147 | 293 | 60 | 500 | 1.826 | 1.782 | 18 |
0.00263 | 128 | 188 | 255 | 57 | 500 | 1.738 | ||
Test Item* | 125 | 168 | 298 | 34 | 500 | 1.732 | 1.733 | 23 |
0.00395 | 126 | 170 | 293 | 37 | 500 | 1.734 | ||
Test Item* | 123 | 187 | 289 | 24 | 500 | 1.674 | 1.656 | 31 |
0.00593 | 124 | 206 | 269 | 25 | 500 | 1.638 | ||
Test Item* | 121 | 228 | 265 | 7 | 500 | 1.558 | 1.535 | 44 |
0.00889 | 122 | 251 | 242 | 7 | 500 | 1.512 | ||
Test Item* | 119 | 316 | 183 | 1 | 500 | 1.370 | 1.393 | 59 |
0.0133 | 120 | 293 | 206 | 1 | 500 | 1.416 | ||
Test Item* | 117 | 391 | 109 | 0 | 500 | 1.218 | 1.225 | 76 |
0.0200 | 118 | 384 | 116 | 0 | 500 | 1.232 | ||
Colchicine | 137 | 495 | 5 | 0 | 500 | 1.010 | 1.007 | 99 |
0.0800 µg/mL | 138 | 498 | 2 | 0 | 500 | 1.004 | ||
Colchicine | 139 | 487 | 13 | 0 | 500 | 1.026 | 1.028 | 97 |
0.0400 µg/mL | 140 | 485 | 15 | 0 | 500 | 1.030 | ||
Main Assay III | ||||||||
Treatment (µL/mL) | Culture No. | MonoN | BiN | PoliN | Total cells | CBPI | Mean Value | Cytotoxicity (%) |
Treatment: 3 h, -S9 | ||||||||
Solvent* | 141 | 297 | 164 | 39 | 500 | 1.484 | 1.482 | 0 |
1% | 142 | 308 | 144 | 48 | 500 | 1.480 | ||
Test Item* | 159 | 344 | 110 | 46 | 500 | 1.404 | 1.484 | 0 |
0.0654 | 160 | 290 | 138 | 72 | 500 | 1.564 | ||
Test Item* | 157 | 324 | 128 | 48 | 500 | 1.448 | 1.436 | 10 |
0.0752 | 158 | 325 | 138 | 37 | 500 | 1.424 | ||
Test Item* | 155 | 319 | 140 | 41 | 500 | 1.444 | 1.441 | 9 |
0.0865 | 156 | 321 | 139 | 40 | 500 | 1.438 | ||
Test Item* | 153 | 333 | 138 | 29 | 500 | 1.392 | 1.389 | 19 |
0.0994 | 154 | 335 | 137 | 28 | 500 | 1.386 | ||
Test Item* | 151 | 380 | 103 | 17 | 500 | 1.274 | 1.266 | 45 |
0.114 | 152 | 379 | 113 | 8 | 500 | 1.258 | ||
Test Item* | 149 | 805 | 190 | 5 | 1000 | 1.200 | 1.213 | 56 |
0.132 | 150 | 783 | 208 | 9 | 1000 | 1.226 | ||
Test Item* | 147 | 428 | 72 | 0 | 500 | 1.144 | 1.134 | 72 |
0.151 | 148 | 438 | 62 | 0 | 500 | 1.124 | ||
Test item* | 145 | Few cells recovered onto slides | ||||||
0.174 | 146 | |||||||
Test Item* | 143 | 396 | 82 | 22 | 500 | 1.252 | ||
0.200 | 144 | Few cells recovered onto slides | ||||||
Cyclophosphamide | 161 | 356 | 142 | 2 | 500 | 1.292 | 1.280 | 42 |
20.0 µg/mL | 162 | 366 | 134 | 0 | 500 | 1.268 | ||
Cyclophosphamide | 163 | 343 | 150 | 7 | 500 | 1.328 | 1.310 | 36 |
15.0 µg/mL | 164 | 358 | 138 | 4 | 500 | 1.292 | ||
*: 2 replicates | ||||||||
MonoN: | Mononucleated cells | |||||||
BiN: | Binucleated cells | |||||||
PoliN: | Polinucleated cells | |||||||
CBPI: | Cytokinesis block proliferation index | |||||||
% Cytotoxicity: | Relative to vehicle/solvent control cultures | |||||||
Mn: | Micronucleus/micronuclei |
Table 2: Scoring of micronuclei
Main Assay II | ||||||
Dose level (μL/mL) | Culture No. | Cells scored (BiN cells) |
BiN cells with 1 Mn |
BiN cells with 2 Mn |
BiN cells with >2 Mn |
BiN cells with Mn |
Treatment: 3 h, -S9 | ||||||
Solvent 1% | 71 | 1000 | 1 | 0 | 0 | 1 |
72 | 1000 | 3 | 0 | 0 | 3 | |
0.0395 | 81 | 1000 | 3 | 0 | 0 | 3 |
82 | 1000 | 2 | 0 | 0 | 2 | |
0.0593 | 79 | 1000 | 3 | 0 | 0 | 3 |
80 | 1000 | 2 | 0 | 0 | 2 | |
0.0889 | 77 | 1000 | 4 | 0 | 0 | 4 |
78 | 1000 | 1 | 0 | 0 | 1 | |
Cyclophosphamide 15.0 µg/mL | 113 | 1000 | 20 | 0 | 0 | 20 |
114 | 1000 | 45 | 1 | 0 | 46 | |
Treatment: 31 h, -S9 | ||||||
Solvent 0.5% | 115 | 1000 | 7 | 0 | 0 | 7 |
116 | 1000 | 2 | 0 | 0 | 2 | |
0.00263 | 127 | 1000 | 3 | 0 | 0 | 3 |
128 | 1000 | 4 | 0 | 0 | 4 | |
0.00593 | 123 | 1000 | 7 | 0 | 0 | 7 |
124 | 1000 | 1 | 0 | 0 | 1 | |
0.0133 | 119 | 1000 | 3 | 0 | 0 | 3 |
120 | 1000 | 4 | 0 | 0 | 4 | |
Colchicine 0.0400 µg/mL |
139 | 1000 | 21 | 5 | 0 | 26 |
140 | 1000 | 16 | 6 | 0 | 22 | |
Main Assay III | ||||||
Dose level (μL/mL) | Culture No. | Cells scored (BiN cells) |
BiN cells with 1 Mn |
BiN cells with 2 Mn |
BiN cells with >2 Mn |
BiN cells with Mn |
Treatment: 3 h, +S9 | ||||||
Solvent 1% | 141 | 1000 | 9 | 1 | 0 | 10 |
142 | 1000 | 7 | 3 | 0 | 10 | |
0.0752 | 157 | 1000 | 9 | 0 | 0 | 9 |
158 | 1000 | 9 | 0 | 0 | 9 | |
0.0994 | 153 | 1000 | 5 | 0 | 0 | 5 |
154 | 1000 | 7 | 0 | 0 | 7 | |
0.132 | 149 | 1000 | 8 | 2 | 0 | 10 |
150 | 1000 | 7 | 0 | 0 | 7 | |
Cyclophosphamide 20.0 µg/mL | 161 | 1000 | 28 | 4 | 0 | 32 |
162 | 1000 | 35 | 4 | 0 | 39 | |
MonoN: | Mononucleated cells | |||||
BiN: | Binucleated cells | |||||
PoliN: | Polinucleated cells | |||||
CBPI: | Cytokinesis block proliferation index | |||||
% Cytotoxicity: | Relative to vehicle/solvent control cultures | |||||
Mn: | Micronucleus/micronuclei |
Table 3: Historical control data
UNTREATED AND SOLVENT CONTROLS | |||
-S9 | +S9 | ||
Short treatment time (3 h) | Long treatment time (31-32 h) | Short treatment time (3 hours) | |
Mean | 0.33 | 0.39 | 0.36 |
SD | 0.21 | 0.30 | 0.24 |
n | 64 | 61 | 64 |
UCL | 0.75 | 0.96 | 0.85 |
LCL | 0.00 | 0.00 | 0.00 |
POSITIVE CONTROL | ||
+S9 | -S9 | |
Short treatment time (3 h) | Long treatment time (31-32 h) | |
Cyclophosphamide | Colchicine | |
Mean | 2.97 | 3.10 |
SD | 1.40 | 1.30 |
n | 51 | 46 |
Minimum | 0.95 | 1.10 |
Maximum | 7.65 | 8.50 |
SD: | Standard deviation |
UCL: | Upper Confidence Limit (Mean value + 2SD) |
LCL: | Lower Confidence Limit (Mean value - 2SD) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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