Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 250-465-0 | CAS number: 31098-20-1
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From: 09 Nov 2021 To: 04 Aug 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay) in vivo mammalian cell study: DNA damage and/or repair
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- Version / remarks:
- July 2016
- Deviations:
- yes
- Remarks:
- This study, according to Sponsor’s request, was performed without analytical concentration determination. The test was performed without bioanalytics due to the physicochemical nature of the test material.
- GLP compliance:
- yes
- Type of assay:
- mammalian comet assay
Test material
- Reference substance name:
- Potassium 3-sulphonatopropyl acrylate
- EC Number:
- 250-465-0
- EC Name:
- Potassium 3-sulphonatopropyl acrylate
- Cas Number:
- 31098-20-1
- Molecular formula:
- C6H10O5S.K
- IUPAC Name:
- potassium 3-(prop-2-enoyloxy)propane-1-sulfonate
- Test material form:
- liquid
- Remarks:
- Colourless
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HAN:WIST of Wistar origin
- Details on species / strain selection:
- Rats are routinely used in this test and the chosen Wistar rat was selected due to a wide range of experience with this strain of rat in corresponding toxicity studies and historical control data at the test facility.
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TOXI-COOP ZRT. H-1103 Budapest, Cserkesz u. 90
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 266-296 g
- Assigned to test groups according to weight ranges
- Housing: 2 - 3 animals/cage in type III polypropylene/polycarbonate cages
- Diet: ssniff® SM R/M-Z+H complete diet for rats and mice produced by Ssniff Spezialdiäten GmbH, D-59494 Soest Germany
- Water: Tap water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): Ventilation provided by central air-condition system. The numbers of air changes per hour was higher than 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 08 Nov 2021 To: 10 Nov 2021
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: ultrapure water (ASTM Type I)
- Justification for choice of vehicle: wherever possible, the use of an aqueous solvent/vehicle should be considered first
- Concentration of test material in vehicle: 197.2, 98.6 and 49.3 mg/mL
- Amount of vehicle: 10 mL/kg - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Test material was dissolved and applied in ultrapure water (ASTM Type I), just before treatment.
- Duration of treatment / exposure:
- The test item was administered in doses by oral gavage twice: once on Day 0 and 24 hours thereafter (on Day 1). The negative control animals were treated concurrently with the vehicle only.
The positive control animals will be treated by oral gavage once during the experiment on Day 1. - Frequency of treatment:
- Once daily
- Post exposure period:
- Tissue sampling was performed 3-4 hours after the second treatment.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day
- Remarks:
- equating to 493 mg/kg bw/day based on a test material purity of 98.6%
- Dose / conc.:
- 1 000 mg/kg bw/day
- Remarks:
- equating to 986 mg/kg bw/day based on a test material purity of 98.6%
- Dose / conc.:
- 2 000 mg/kg bw/day
- Remarks:
- equating to 1972 mg/kg bw/day based on a test material purity of 98.6%
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Ethylmethanesulphonate
- Justification for choice of positive control(s): EMS is a known mutagen and is recommended in the OECD 489 test guideline for use with any target tissue
- Route of administration: Oral
- Concentration: 20 mg/mL
Examinations
- Tissues and cell types examined:
- Glandular stomach cells, duodenum cells and liver cells
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: A non GLP preliminary trial was performed using 2 animals at a dose of 2000 mg/kg bw/day. The treatment was performed on two consecutive days with about a 24 hour interval. At the chosen concentration level neither mortality nor clinical signs, or any suffering of animals were observed.
TREATMENT AND SAMPLING TIMES: Animals were due to be dosed with the test item at 2000, 1000 and 500 mg/kg bw/day. At the formulation of these doses, correction of concentrations for test item purity (98.6 %) was not performed; consequently, the doses administered corresponded to: 1972, 986 and 493 mg/kg bw/day. Considering the small difference between planned (corrected) concentrations and non-corrected applied concentrations, the 2000, 1000 and 500 mg/kg bw/day values were used and reported throughout the report. The animals were observed for morbidity, mortality and for general symptoms, clinical signs 1, 2 and 4 hours after the first treatment (Day 0), just before the second treatment on Day 1; furthermore 1 and 2 hours after the second treatment and shortly before sampling time (on Day 1). These animals were weighted before each treatment, and at sacrifice. At tissue isolation, the appearance of the target tissues and organs were observed and recorded. Samples of target organs tissues were preserved in 4 % formaldehyde solution in the testing laboratory until delivery of the final report to enable any further analysis.
DETAILS OF SLIDE PREPARATION: The stomach was cut open and washed free of food using cold phosphate buffered saline. The forestomach was removed and discarded. The glandular stomach as then placed into cold mincing buffer and incubated on ice for a short period of time. After the incubation, the surface epithelia were gently scraped using a scalpel blade. This layer was discarded and the gastric mucosa rinsed with cold mincing buffer. The stomach epithelia was carefully scraped at least 4-5 times with scalpel blade. The cell suspension was stored on ice for about 30 seconds to allow the large clumps to settle. The supernatant was used to prepare the comet slides. A representative duodenum sample was removed, cut open lengthwise and washed thoroughly with cold phosphate buffered saline. The duodenum sample was then placed into cold mincing buffer and incubated on ice for a short period of time (< 1 minute). The surface epithelia was gently scraped using tweezers and/or scalpel blade. The obtained cell suspension was stored on ice for about 30 seconds to allow the large clumps to settle. The supernatant was used to prepare the comet slides. A portion of the left lateral lobe of the liver was removed and washed in cold mincing buffer until as much blood as possible was removed. The tissue was then placed in mincing buffer (ice cold Hank’s Balanced Salt Solution (HBSS) containing 20 mM EDTA and 10 % DMSO) and minced with a pair of fine scissors to release the cells. The cell suspension was stored on ice for about 30 seconds to allow the large clumps to settle. The supernatant was used to prepare the comet slides.
4Before slide preparation (embedding the cells) the proportion of viable cells were scored using a Trypan blue technique. Cytotoxicity was determined on a small sample of each isolated cell suspension following the Trypan blue dye exclusion technique. The decrease of viability should not be more than 30 % when compared to the concurrent control. The viability results obtained with the dye exclusion method was used for the approval of the appropriateness and efficiency of the applied experimental conditions (e.g. tissue isolation techniques) and as additional information about the quality of the cell sample for the subsequent experimental parts. The slide preparation was conducted within one hour following single cell preparation. At least three slides were prepared for each animal for each tissue sample.
Pre-treatment of slides: According to general procedure, the conventional (superfrost) slides were dipped in hot 0.5 % normal melting point agarose in water. After gentle removal, the underside of the slides were wiped in order to remove the excess of agarose. The slides were then laid on a flat surface and allowed to dry.
Embedding the cells: Before use, a volume of 130 μL of 0.5 % normal melting point agarose (NMA) was added on a microscope slide, pre-layered with 0.5 % NMA (see above) and covered with a glass coverslip. The slides was placed on a tray until the agarose hardened (~ 5 minutes). After the cell isolations, the cell suspension was mixed with 0.5 % or 1.0 % Low Melting Point Agarose (LMPA). Thereafter (~1E4 –1E5 cells) of this mixture will be added on the microscope slide after gently sliding off the coverslip. The microscope slides were covered with a new coverslip. After the LMPA-cell mixture hardened, an additional 70 μL of NMA was dropped onto the microscope slide after gently sliding off the (second) coverslip and a new coverslip was laid on the slide. After the repeated NMA layer hardened, the coverslip was removed. The slides were removed from the lysing solution and randomly placed on a horizontal gel electrophoresis unit. The unit was filled with freshly prepared electrophoresis solution until the surfaces of the slides were completely covered with the solution (to about 1-2 mm above the slides). The slides were left for 30 min. for the DNA to unwind. Thereafter the electrophoresis was conducted for 30 min. by applying a constant voltage of 0.7 V/cm and an electric current of about 300 mA. The current was recorded at the start and end of the electrophoresis period. After electrophoresis, the slides were removed from the electrophoresis unit, covered with neutralization solution, allowed to stand covered for about 5 minutes, blotted and covered again with neutralization solution. This procedure was repeated twice. Subsequently the slides were exposed for an additional 5 minutes to absolute ethanol. Just prior comet scoring, the DNA was stained using 2 μg/mL Ethidium bromide.
METHOD OF ANALYSIS: Coded slides were stained and blind scored. The comets were measured via a digital camera linked to an image analyzer system using a fluorescence microscope equipped with an appropriate excitation filter at a magnification of 200X. For each tissue sample, fifty cells per slide were randomly scored i.e. 150 cells per animal (750 analyzed cells per test item treatment, per vehicle control and 450 per positive controls). DNA strand breaks were measured by independent endpoints such as % tail DNA, tail moment and tail length. In addition, each slide was examined for presence of ghost cells (possible indicator of toxicity and/or apoptosis).
BIOANALYSIS: Due to the chemical characteristics of the test item, bioanalysis was not conducted in this study. The test item is highly hydrophilic, therefore, its passage through the lipophilic membranes is expected to be rather limited. The molecule is labile, it rapidly decomposes in the gastrointestinal tract to metabolites such as acrylic acid. These degradation products will also be rapidly metabolized further. Thus, the systemic absorption following oral administration of the parent test item is judged to be very low. The expected concentration of the parent material (if present at all) in the blood would not be detected even if a very high sensitive LC-MS/MS instrument was used. Furthermore, for a method development and validation, spiked blood plasma samples (calibrator, quality control samples)
would be needed. However due to the labile nature of the molecule, the esterase enzymes would rapidly decompose the spiked test item, consequently no quantitative analytics could be conducted.
In this study no histopathological examination was required due to the negative results observed. - Evaluation criteria:
- Providing that all validity criteria are fulfilled, the test chemical is clearly negative if:
- none of the test concentrations exhibits a statistically significant increase compared with the concurrent negative control;
- there is no concentration-related increase when evaluated with an appropriate trend test;
- all results are inside the distribution of the historical negative control data for given species, vehicle, route, tissue and number of administration;
- direct or indirect evidence supportive of exposure of, or toxicity to, the target tissue(s) is demonstrated.
Providing that all validity criteria are fulfilled, the test chemical is clearly positive if:
- at least one of the test concentrations exhibits a statistically significant increase compared with the concurrent negative control;
- the increase is dose-related when evaluated with an appropriate trend test;
- any of the results are outside the distribution of the historical negative control data for given species, vehicle, route, tissue and number of administration; - Statistics:
- The statistical significance of % tail DNA values; furthermore, the number of ghost cells was carried out using the appropriate statistical method, using SPSS software.
The homogeneity of variance between groups was checked by Levene's Test for Equality of Variances, the normal distribution of data was examined by Kolmogorov-Smirnov test. Following these analyses, a one-way analysis of variance following by Dunnett’s test was used to compare the vehicle control value and the corresponding values of test item doses or the inter-group comparisons were performed using non-parametric Mann-Whitney U-test.
The respective values of positive control were compared with corresponding negative control data using 2-Sample t-Test.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- No mortality or toxicity was observed during the treatments and expression period in any dose group up to the limit dose of 2000 mg/kg bw/day and in the controls.
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- All of the validity criteria regarding the negative control treatments as well as the number of analysed cells, and the investigated dose levels were met
- Positive controls validity:
- valid
- Remarks:
- All of the validity criteria regarding the positive control treatments as well as the number of analysed cells, and the investigated dose levels were met
- Additional information on results:
- All of the validity criteria regarding the negative and positive control treatments as well as the number of analysed cells, and the investigated dose levels were met (See: Validity of the Study). No mortality was observed during the treatments and expression period in any dose group up to the limit dose of 2000 mg/kg bw/day and in the controls. Neither toxic symptoms nor any clinical signs were observed during the treatments in the dose levels and controls. At the tissue isolation normal appearance and anatomy of stomach, duodenum and liver was noticed in all dose levels and controls. No signs of toxicity or local test item effects were noticed in the test item treated doses and controls.
In all dose groups as well as in the negative and positive control groups the average body weight changes (slight decreases and increases: -2.53 – 0.35 %) when comparing values measured on Day 0 and measured just before the sacrifice were in the typical range for studies of this duration. At the cytotoxicity screening measurements (using Trypan blue dye exclusion method) no cytotoxicity was noticed in any test and control item treatments for any target tissue. All of the ghost cell percentages obtained at the test item treated groups and controls of liver samples remained well within the laboratory’s historical control data ranges. The occasional, slight outlier (higher) ghost cell percentages obtained at the stomach and duodenum samples were considered acceptable, not extreme outliers, their appearance frequency remained within the biological variability range of the applied test system. Additionally, at the examined test item dose groups, the number of ghost cells in the stomach, duodenum and liver samples did not differ statistically significantly from that of the vehicle control. The observed relatively higher percentage of ghost cells at the EMS treatments (stomach: 23 %, duodenum: 21 %, and liver 7 %) were within the testing laboratory’s range for EMS positive control in all tissue preparations. The increased frequencies differed statistically significantly from that of the negative control in the stomach, duodenum and liver samples. This is a common finding according to historical control data and related to the cellular toxicity of EMS. All of the group mean median % tail DNA values of each dose remained well within the vehicle control range at the examined tissues, and the slightly higher or lower values did not differ statistically significantly from that of the vehicle control up to the highest dose of 2000 mg/kg bw/day. Furthermore, the mean median % tail DNA values (groups mean values) of the test item doses in the stomach, duodenum and liver samples were in line with the corresponding historical control data ranges (within the 95 % confidence intervals, C-charts). The group mean values below the historical control data ranges (e.g.: stomach and liver samples) were not extreme outliers in any case.
Additionally, for informative reason the tail length values and Olive Tail Moment (OTM) of the vehicle control and each treatment were compared. The obtained tail length and OTM values (group means of dose groups), similarly to the main parameter % tail DNA values were in line with the corresponding historical control data ranges (within the 95 % confidence intervals, C-charts). All of the outlier values of the above parameters were further analyzed, compared with laboratory’s existing robust databases and were considered acceptable and to represent biological variability of the applied test system
Any other information on results incl. tables
Table 1: Observations, Weight Changes Observed During the Treatments
Dose | Days of treatments | Toxic symptoms |
Ultrapure water (ASTM Type I) x2 | Day 0 (November 09, 2021) | 1 hour after the first treatment: no symptoms |
Day 1 (November 10, 2021) | Just before the second treatment: no symptoms | |
Potassium 3-sulphonatopropyl acrylate | Day 0 (November 09, 2021) | 1 hour after the first treatment: no symptoms |
Day 1 (November 10, 2021) | Just before the second treatment: no symptoms | |
Potassium 3-sulphonatopropyl acrylate | Day 0 (November 09, 2021) | 1 hour after the first treatment: no symptoms |
Day 1 (November 10, 2021) | Just before the second treatment: no symptoms | |
Potassium 3-sulphonatopropyl acrylate | Day 0 (November 09, 2021) | 1 hour after the first treatment: no symptoms |
Day 1 (November 10, 2021) | Just before the second treatment: no symptoms | |
EMS | Day 1 (November 10, 2021) | 1 hour after the treatment: no symptoms |
EMS : Ethyl methanesulfonate
Table 2: General Observations, Noticed During the Tissue (Cell) Isolation
Animal Number | Toxic symptoms at sacrifice and tissue (cell) isolations |
Negative Control (Ultrapure water (ASTM Type I) x2) | |
94 | The appearance of the target organs (stomach, duodenum and liver) was normal, |
98 | |
103 | |
105 | |
108 | |
109 | |
Test Item Treatment Potassium 3-sulphonatopropyl acrylate [500 mg/kg bw/day (x2)] | |
89 | The appearance of the target organs (stomach, duodenum and liver) was normal, |
90 | |
91 | |
92 | |
100 | |
101 | |
Test Item Treatment Potassium 3-sulphonatopropyl acrylate [1000 mg/kg bw/day (x2)] | |
87 | The appearance of the target organs (stomach, duodenum and liver) was normal, |
88 | |
96 | |
99 | |
106 | |
112 | |
Test Item Treatment Potassium 3-sulphonatopropyl acrylate [2000 mg/kg bw/day (x2)] | |
95 | The appearance of the target organs (stomach, duodenum and liver) was normal, |
97 | |
107 | |
110 | |
111 | |
113 | |
Positive Control EMS [200 mg/kg bw/day (x1)] | |
93 | The appearance of the target organs (stomach, duodenum and liver) was normal, |
102 | |
104 | |
114 |
EMS : Ethyl methanesulfonate
Table 3: Cell Concentrations of the Prepared Cell Suspensions and Cell Number on the Slides
Animal Number | Cell concentration (cell/mL) | Cell number on the slide | Cell concentration (cell/mL) | Cell number on the slide | Cell concentration (cell/mL) | Cell number on the slide |
Negative Control (Ultrapure water (ASTM Type I) x2) | ||||||
94 | 1.59 x 106 | 3.18 x 104 | 2.80 x 106 | 5.60 x 104 | 4.70 x 106 | 9.40 x 104 |
98 | 2.92 x 106 | 5.83 x 104 | 2.01 x 106 | 4.01 x 104 | 8.00 x 106 | 1.60 x 105 |
103 | 3.54 x 106 | 7.08 x 104 | 4.75 x 106 | 9.50 x 104 | 8.08 x 106 | 1.62 x 105 |
105 | 4.83 x 106 | 9.67 x 104 | 1.72 x 106 | 3.45 x 104 | 8.00 x 106 | 1.60 x 105 |
108 | 4.96 x 106 | 9.92 x 104 | 2.19 x 106 | 4.38 x 104 | 6.75 x 106 | 1.35 x 105 |
109 | 5.30 x 105 | 2.12 x 104 | 1.14 x 106 | 4.56 x 104 | 6.75 x 106 | 1.35 x 105 |
Test Item Treatment Potassium 3-sulphonatopropyl acrylate [500 mg/kg bw/day (x2)] | ||||||
89 | 3.30 x 106 | 6.60 x 104 | 4.46 x 106 | 8.92 x 104 | 5.00 x 106 | 1.00 x 105 |
90 | 2.50 x 106 | 5.00 x 104 | 5.54 x 106 | 1.11 x 105 | 5.05 x 106 | 1.01 x 105 |
91 | 2.83 x 106 | 5.67 x 104 | 4.85 x 106 | 9.70 x 104 | 9.70 x 106 | 1.94 x 105 |
92 | 3.46 x 106 | 6.92 x 104 | 1.46 x 106 | 2.91 x 104 | 4.95 x 106 | 9.90 x 104 |
100 | 2.70 x 106 | 1.08 x 105 | 1.54 x 106 | 6.15 x 104 | 7.88 x 106 | 1.58 x 105 |
101 | 1.38 x 106 | 5.51 x 104 | 1.11 x 106 | 2.22 x 104 | 5.40 x 106 | 1.08 x 105 |
Test Item Treatment Potassium 3-sulphonatopropyl acrylate [1000 mg/kg bw/day (x2)] | ||||||
87 | 1.40 x 106 | 2.80 x 104 | 1.30 x 106 | 5.21 x 104 | 3.50 x 106 | 7.00 x 104 |
88 | 1.46 x 106 | 2.92 x 104 | 3.96 x 106 | 7.92 x 104 | 3.90 x 106 | 7.80 x 104 |
96 | 8.46 x 105 | 3.38 x 104 | 1.34 x 106 | 5.37 x 104 | 3.70 x 106 | 7.40 x 104 |
99 | 1.27 x 106 | 5.07 x 104 | 1.18 x 106 | 4.72 x 104 | 4.70 x 106 | 9.40 x 104 |
106 | 4.38 x 106 | 8.75 x 104 | 1.98 x 106 | 3.96 x 104 | 5.19 x 106 | 1.04 x 105 |
112 | 1.66 x 106 | 3.32 x 104 | 1.59 x 106 | 6.34 x 104 | 5.25 x 106 | 1.05 x 105 |
Test Item Treatment Potassium 3-sulphonatopropyl acrylate [2000 mg/kg bw/day (x2)] | ||||||
95 | 4.88 x 106 | 9.75 x 104 | 1.89 x 105 | 3.77 x 104 | 4.81 x 106 | 9.63 x 104 |
97 | 2.00 x 106 | 4.00 x 104 | 2.01 x 106 | 4.02 x 104 | 3.13 x 106 | 6.25 x 104 |
107 | 1.77 x 106 | 3.55 x 104 | 1.93 x 106 | 3.87 x 104 | 3.06 x 106 | 6.13 x 104 |
110 | 5.92 x 106 | 1.18 x 105 | 4.79 x 106 | 9.58 x 104 | 4.63 x 106 | 9.25 x 104 |
111 | 1.45 x 106 | 2.90 x 104 | 4.20 x 106 | 8.40 x 104 | 4.50 x 106 | 9.00 x 104 |
113 | 1.17 x 106 | 2.33 x 104 | 1.77 x 106 | 3.54 x 104 | 3.81 x 106 | 7.63 x 104 |
Positive Control EMS [200 mg/kg bw/day (x1)] | ||||||
93 | 1.75 x 106 | 6.98 x 104 | 1.65 x 106 | 3.31 x 104 | 3.88 x 106 | 7.75 x 104 |
102 | 9.57 x 105 | 3.83 x 104 | 1.57 x 106 | 3.14 x 104 | 4.63 x 106 | 9.25 x 104 |
104 | 1.38 x 106 | 5.52 x 104 | 3.88 x 106 | 7.75 x 104 | 4.75 x 106 | 9.50 x 104 |
114 | 4.13 x 106 | 8.25 x 104 | 3.00 x 106 | 6.00 x 104 | 4.30 x 106 | 8.60 x 104 |
EMS : Ethyl methanesulfonate
Table 4: Viability of the Isolated Cells (Stomach, Duodenum and Liver)
Dose | Animal Number | Percentage of Viability (Stomach) (%) | Average viability (Stomach) % / Dose | Percentage of Viability (Duodenum) (%) | Average viability (Duodenum) % / Dose | Percentage of Viability (Liver) (%) | Average viability (Liver) % / Dose |
Ultrapure water (ASTM Type I) x2 | 94 | 88.6 | 83.18 | 74.4 | 74.12 | 95.7 | 97.06 |
98 | 94.3 | 73.2 | 96.9 | ||||
103 | 94.1 | 77.2 | 96.9 | ||||
105 | 74.1 | 73.3 | 97.7 | ||||
108 | 75.6 | 73.6 | 98.1 | ||||
109 | 72.3 | 73.1 | 97.0 | ||||
Potassium 3-sulphonatopropyl acrylate | 89 | 92.4 | 88.07 | 73.8 | 76.91 | 97.0 | 96.86 |
90 | 93.3 | 72.2 | 96.0 | ||||
91 | 94.1 | 71.1 | 97.4 | ||||
92 | 97.6 | 90.7 | 96.0 | ||||
100 | 70.4 | 79.5 | 98.4 | ||||
101 | 80.6 | 74.1 | 96.3 | ||||
Potassium 3-sulphonatopropyl acrylate | 87 | 89.3 | 83.52 | 80.1 | 75.32 | 94.3 | 95.21 |
88 | 85.7 | 72.6 | 94.9 | ||||
96 | 80.1 | 72.0 | 95.9 | ||||
99 | 75.9 | 79.5 | 95.7 | ||||
106 | 74.3 | 76.8 | 94.0 | ||||
112 | 95.8 | 71.0 | 96.4 | ||||
Potassium 3-sulphonatopropyl acrylate | 95 | 72.6 | 80.68 | 72.1 | 74.75 | 94.8 | 95.02 |
97 | 90.0 | 77.3 | 92.0 | ||||
107 | 77.6 | 76.9 | 91.8 | ||||
110 | 74.6 | 72.2 | 97.3 | ||||
111 | 82.8 | 70.2 | 95.8 | ||||
113 | 86.4 | 79.8 | 98.4 | ||||
EMS | 93 | 73.4 | 78.83 | 80.2 | 76.96 | 95.2 | 96.88 |
102 | 86.8 | 78.1 | 98.6 | ||||
104 | 78.4 | 73.1 | 96.1 | ||||
114 | 76.8 | 76.4 | 97.7 |
EMS : Ethyl methanesulfonate
Table 5: % Tail DNA, Medians per Slide, Mean Medians per Animal, per Dose (Stomach)
Dose | Animal number | Slide code | Number of analysed cells/slide | Number of analysed cells/animal | % Tail DNA | ||
Per slide | Per animal | Per dose | |||||
(Median of 50 cells) | (Mean Median of 150 cells) | (Group Mean of 900 cells)1) | |||||
Ultrapure water (ASTM Type I) x2 | 94 | 94S1 | 50 | 150 | 4.07 | 3.67 | 6.28 |
94S2 | 50 | 4.54 | |||||
94S3 | 50 | 2.41 | |||||
98 | 98S1 | 50 | 150 | 4.26 | 5.12 | ||
98S2 | 50 | 7.86 | |||||
98S3 | 50 | 3.25 | |||||
103 | 103S1 | 50 | 150 | 6.98 | 8.19 | ||
103S2 | 50 | 10.05 | |||||
103S3 | 50 | 7.53 | |||||
105 | 105S1 | 50 | 150 | 49.19 | 47.49 # | ||
105S2 | 50 | 48.93 | |||||
105S3 | 50 | 44.35 | |||||
108 | 108S1 | 50 | 150 | 4.09 | 6.47 | ||
108S2 | 50 | 5.20 | |||||
108S3 | 50 | 10.12 | |||||
109 | 109S1 | 50 | 150 | 5.87 | 7.97 | ||
109S2 | 50 | 9.24 | |||||
109S3 | 50 | 8.80 | |||||
Potassium 3-sulphonatopropyl acrylate | 89 | 89S1 | 50 | 150 | 4.66 | 6.31 | 5.60 |
89S2 | 50 | 8.25 | |||||
89S3 | 50 | 6.01 | |||||
90 | 90S1 | 50 | 150 | 4.73 | 4.68 | ||
90S2 | 50 | 4.53 | |||||
90S3 | 50 | 4.78 | |||||
91 | 91S1 | 50 | 150 | 3.91 | 3.83 | ||
91S2 | 50 | 4.29 | |||||
91S3 | 50 | 3.31 | |||||
92 | 92S1 | 50 | 150 | 2.54 | 3.84 | ||
92S2 | 50 | 6.42 | |||||
92S3 | 50 | 2.56 | |||||
100 | 100S1 | 50 | 150 | 6.38 | 5.47 | ||
100S2 | 50 | 4.21 | |||||
100S3 | 50 | 5.83 | |||||
101 | 101S1 | 50 | 150 | 11.22 | 9.48 | ||
101S2 | 50 | 4.63 | |||||
101S3 | 50 | 12.59 |
# : The animal coded “105” was excluded from the evaluation.
1) : In the case of ultrapure water vehicle control 750 cells/tissue
SD : Standard deviation
NS : Statistically not significant (Dunnett’s Test)
Table 5: % Tail DNA, Medians per Slide, Mean Medians per Animal, per Dose (Stomach) (continued)
Dose | Animal number | Slide code | Number of analysed cells/slide | Number of analysed cells/animal | % Tail DNA | ||
Per slide | Per animal | Per dose | |||||
(Median of 50 cells) | (Mean Median of 150 cells) | (Group Mean of 900 cells) | |||||
Potassium 3-sulphonatopropyl acrylate | 87 | 87S1 | 50 | 150 | 7.84 | 7.23 | 4.65 |
87S2 | 50 | 7.83 | |||||
87S3 | 50 | 6.04 | |||||
88 | 88S1 | 50 | 150 | 3.41 | 4.97 | ||
88S2 | 50 | 6.25 | |||||
88S3 | 50 | 5.27 | |||||
96 | 96S1 | 50 | 150 | 3.68 | 3.99 | ||
96S2 | 50 | 1.77 | |||||
96S3 | 50 | 6.52 | |||||
99 | 99S1 | 50 | 150 | 3.21 | 3.51 | ||
99S2 | 50 | 3.20 | |||||
99S3 | 50 | 4.12 | |||||
106 | 106S1 | 50 | 150 | 2.73 | 3.77 | ||
106S2 | 50 | 4.42 | |||||
106S3 | 50 | 4.16 | |||||
112 | 112S1 | 50 | 150 | 3.62 | 4.41 | ||
112S2 | 50 | 5.63 | |||||
112S3 | 50 | 3.99 | |||||
Potassium 3-sulphonatopropyl acrylate | 95 | 95S1 | 50 | 150 | 2.65 | 3.21 | 5.49 |
95S2 | 50 | 2.02 | |||||
95S3 | 50 | 4.97 | |||||
97 | 97S1 | 50 | 150 | 6.80 | 6.52 | ||
97S2 | 50 | 5.50 | |||||
97S3 | 50 | 7.27 | |||||
107 | 107S1 | 50 | 150 | 3.70 | 4.91 | ||
107S2 | 50 | 6.67 | |||||
107S3 | 50 | 4.35 | |||||
110 | 110S1 | 50 | 150 | 8.91 | 8.53 | ||
110S2 | 50 | 10.07 | |||||
110S3 | 50 | 6.63 | |||||
111 | 111S1 | 50 | 150 | 3.33 | 4.06 | ||
111S2 | 50 | 3.00 | |||||
111S3 | 50 | 5.86 | |||||
113 | 113S1 | 50 | 150 | 7.79 | 5.69 | ||
113S2 | 50 | 5.76 | |||||
113S3 | 50 | 3.53 |
SD : Standard deviation
NS : Statistically not significant (Dunnett’s Test)
Table 5: % Tail DNA, Medians per Slide, Mean Medians per Animal, per Dose (Stomach) (continued)
Dose | Animal number | Slide code | Number of analysed cells/slide | Number of analysed cells/animal | % Tail DNA | ||
Per slide | Per animal | Per dose | |||||
(Median of 50 cells) | (Mean Median of 150 cells) | (Group Mean of 600 cells) | |||||
EMS | 93 | 93S1 | 50 | 150 | 23.22 | 29.06 | 25.60 |
93S2 | 50 | 29.89 | |||||
93S3 | 50 | 34.08 | |||||
102 | 102S1 | 50 | 150 | 25.06 | 20.72 | ||
102S2 | 50 | 19.88 | |||||
102S3 | 50 | 17.21 | |||||
104 | 104S1 | 50 | 150 | 23.50 | 23.57 | ||
104S2 | 50 | 23.20 | |||||
104S3 | 50 | 24.02 | |||||
114 | 114S1 | 50 | 150 | 29.41 | 29.04 | ||
114S2 | 50 | 24.81 | |||||
114S3 | 50 | 32.92 |
EMS : Ethyl methanesulfonate
SD : Standard deviation
** : Statistically significant (2-Sample T-test; α = 0.01)
Table 6: % Tail DNA, Medians per Slide, Mean Medians per Animal, per Dose (Duodenum)
Dose | Animal number | Slide code | Number of analysed cells/slide | Number of analysed cells/animal | % Tail DNA | ||
Per slide | Per animal | Per dose | |||||
(Median of 50 cells) | (Mean Median of 150 cells) | (Group Mean of 900 cells)1) | |||||
Ultrapure water (ASTM Type I) x2 | 94 | 94D1 | 50 | 150 | 6.22 | 4.41 | 7.42 |
94D2 | 50 | 3.63 | |||||
94D3 | 50 | 3.39 | |||||
98 | 98D1 | 50 | 150 | 5.24 | 5.06 | ||
98D2 | 50 | 2.19 | |||||
98D3 | 50 | 7.74 | |||||
103 | 103D1 | 50 | 150 | 26.12 | 21.00 | ||
103D2 | 50 | 14.65 | |||||
103D3 | 50 | 22.23 | |||||
105 | 105D1 | 50 | 150 | 9.48 | 6.32# | ||
105D2 | 50 | 5.93 | |||||
105D3 | 50 | 3.57 | |||||
108 | 108D1 | 50 | 150 | 3.05 | 3.84 | ||
108D2 | 50 | 4.14 | |||||
108D3 | 50 | 4.34 | |||||
109 | 109D1 | 50 | 150 | 2.00 | 2.79 | ||
109D2 | 50 | 2.57 | |||||
109D3 | 50 | 3.82 | |||||
Potassium 3-sulphonatopropyl acrylate | 89 | 89D1 | 50 | 150 | 2.65 | 3.29 | 3.23 |
89D2 | 50 | 2.06 | |||||
89D3 | 50 | 5.18 | |||||
90 | 90D1 | 50 | 150 | 2.15 | 2.50 | ||
90D2 | 50 | 2.86 | |||||
90D3 | 50 | 2.49 | |||||
91 | 91D1 | 50 | 150 | 2.04 | 2.59 | ||
91D2 | 50 | 1.72 | |||||
91D3 | 50 | 4.01 | |||||
92 | 92D1 | 50 | 150 | 1.54 | 2.04 | ||
92D2 | 50 | 3.13 | |||||
92D3 | 50 | 1.45 | |||||
100 | 100D1 | 50 | 150 | 5.28 | 4.46 | ||
100D2 | 50 | 4.90 | |||||
100D3 | 50 | 3.19 | |||||
101 | 101D1 | 50 | 150 | 5.48 | 4.50 | ||
101D2 | 50 | 2.77 | |||||
101D3 | 50 | 5.26 |
# : The animal coded “105” was excluded from the evaluation.
1) : In the case of ultrapure water vehicle control 750 cells/tissue
SD : Standard deviation
NS : Statistically not significant (Mann-Whitney U Test)
Table 6: % Tail DNA, Medians per Slide, Mean Medians per Animal, per Dose (Duodenum) (continued)
Dose | Animal number | Slide code | Number of analysed cells/slide | Number of analysed cells/animal | % Tail DNA | ||
Per slide | Per animal | Per dose | |||||
(Median of 50 cells) | (Mean Median of 150 cells) | (Group Mean of 900 cells) | |||||
Potassium 3-sulphonatopropyl acrylate | 87 | 87D1 | 50 | 150 | 1.95 | 3.10 | 4.03 |
87D2 | 50 | 4.82 | |||||
87D3 | 50 | 2.55 | |||||
88 | 88D1 | 50 | 150 | 1.94 | 1.86 | ||
88D2 | 50 | 2.24 | |||||
88D3 | 50 | 1.40 | |||||
96 | 96D1 | 50 | 150 | 5.62 | 4.43 | ||
96D2 | 50 | 3.89 | |||||
96D3 | 50 | 3.79 | |||||
99 | 99D1 | 50 | 150 | 2.96 | 3.47 | ||
99D2 | 50 | 5.11 | |||||
99D3 | 50 | 2.36 | |||||
106 | 106D1 | 50 | 150 | 2.54 | 4.58 | ||
106D2 | 50 | 4.47 | |||||
106D3 | 50 | 6.75 | |||||
112 | 112D1 | 50 | 150 | 4.44 | 6.74 | ||
112D2 | 50 | 8.44 | |||||
112D3 | 50 | 7.34 | |||||
Potassium 3-sulphonatopropyl acrylate | 95 | 95D1 | 50 | 150 | 2.17 | 2.32 | 5.41 |
95D2 | 50 | 1.86 | |||||
95D3 | 50 | 2.93 | |||||
97 | 97D1 | 50 | 150 | 15.50 | 12.30 | ||
97D2 | 50 | 14.50 | |||||
97D3 | 50 | 6.90 | |||||
107 | 107D1 | 50 | 150 | 2.37 | 4.11 | ||
107D2 | 50 | 7.20 | |||||
107D3 | 50 | 2.77 | |||||
110 | 110D1 | 50 | 150 | 3.91 | 4.13 | ||
110D2 | 50 | 2.56 | |||||
110D3 | 50 | 5.94 | |||||
111 | 111D1 | 50 | 150 | 4.55 | 4.32 | ||
111D2 | 50 | 6.01 | |||||
111D3 | 50 | 2.41 | |||||
113 | 113D1 | 50 | 150 | 3.31 | 5.27 | ||
113D2 | 50 | 6.72 | |||||
113D3 | 50 | 5.78 |
SD : Standard deviation
NS : Statistically not significant (Mann-Whitney U Test)
Table 6: % Tail DNA, Medians per Slide, Mean Medians per Animal, per Dose (Duodenum) (continued)
Dose | Animal number | Slide code | Number of analysed cells/slide | Number of analysed cells/animal | % Tail DNA | ||
Per slide | Per animal | Per dose | |||||
(Median of 50 cells) | (Mean Median of 150 cells) | (Group Mean of 600 cells) | |||||
EMS | 93 | 93D1 | 50 | 150 | 24.03 | 22.45 | 19.46 |
93D2 | 50 | 23.04 | |||||
93D3 | 50 | 20.28 | |||||
102 | 102D1 | 50 | 150 | 15.52 | 14.83 | ||
102D2 | 50 | 15.20 | |||||
102D3 | 50 | 13.76 | |||||
104 | 104D1 | 50 | 150 | 17.84 | 16.16 | ||
104D2 | 50 | 15.35 | |||||
104D3 | 50 | 15.28 | |||||
114 | 114D1 | 50 | 150 | 22.36 | 24.41 | ||
114D2 | 50 | 23.30 | |||||
114D3 | 50 | 27.59 |
EMS : Ethyl methanesulfonate
SD : Standard deviation
* : Statistically significant (2-Sample T-test; α = 0.05)
Table 7: % Tail DNA, Medians per Slide, Mean Medians per Animal, per Dose (Liver)
Dose | Animal number | Slide code | Number of analysed cells/slide | Number of analysed cells/animal | % Tail DNA | ||
Per slide | Per animal | Per dose | |||||
(Median of 50 cells) | (Mean Median of 150 cells) | (Group Mean of 900 cells)1) | |||||
Ultrapure water (ASTM Type I) x2 | 94 | 94L1 | 50 | 150 | 3.87 | 4.97 | 4.37 |
94L2 | 50 | 5.15 | |||||
94L3 | 50 | 5.90 | |||||
98 | 98L1 | 50 | 150 | 5.38 | 3.72 | ||
98L2 | 50 | 2.51 | |||||
98L3 | 50 | 3.27 | |||||
103 | 103L1 | 50 | 150 | 2.12 | 4.16 | ||
103L2 | 50 | 3.05 | |||||
103L3 | 50 | 7.30 | |||||
105 | 105L1 | 50 | 150 | 2.64 | 3.62# | ||
105L2 | 50 | 4.27 | |||||
105L3 | 50 | 3.95 | |||||
108 | 108L1 | 50 | 150 | 4.72 | 4.53 | ||
108L2 | 50 | 4.77 | |||||
108L3 | 50 | 4.11 | |||||
109 | 109L1 | 50 | 150 | 5.02 | 4.47 | ||
109L2 | 50 | 5.84 | |||||
109L3 | 50 | 2.54 | |||||
Potassium 3-sulphonatopropyl acrylate | 89 | 89L1 | 50 | 150 | 4.41 | 4.21 | 3.54 |
89L2 | 50 | 4.15 | |||||
89L3 | 50 | 4.07 | |||||
90 | 90L1 | 50 | 150 | 2.42 | 2.82 | ||
90L2 | 50 | 4.03 | |||||
90L3 | 50 | 2.03 | |||||
91 | 91L1 | 50 | 150 | 3.37 | 3.23 | ||
91L2 | 50 | 3.30 | |||||
91L3 | 50 | 3.02 | |||||
92 | 92L1 | 50 | 150 | 3.22 | 3.01 | ||
92L2 | 50 | 2.55 | |||||
92L3 | 50 | 3.26 | |||||
100 | 100L1 | 50 | 150 | 3.80 | 4.17 | ||
100L2 | 50 | 3.12 | |||||
100L3 | 50 | 5.60 | |||||
101 | 101L1 | 50 | 150 | 1.67 | 3.81 | ||
101L2 | 50 | 4.55 | |||||
101L3 | 50 | 5.23 |
# : The animal coded “105” was excluded from the evaluation.
1) : In the case of ultrapure water vehicle control 750 cells/tissue
SD : Standard deviation
NS : Statistically not significant (Dunnett’s Test)
Table 7: % Tail DNA, Medians per Slide, Mean Medians per Animal, per Dose (Liver) (continued)
Dose | Animal number | Slide code | Number of analysed cells/slide | Number of analysed cells/animal | % Tail DNA | ||
Per slide | Per animal | Per dose | |||||
(Median of 50 cells) | (Mean Median of 150 cells) | (Group Mean of 900 cells) | |||||
Potassium 3-sulphonatopropyl acrylate | 87 | 87L1 | 50 | 150 | 5.65 | 3.96 | 3.35 |
87L2 | 50 | 4.14 | |||||
87L3 | 50 | 2.09 | |||||
88 | 88L1 | 50 | 150 | 2.87 | 3.62 | ||
88L2 | 50 | 4.51 | |||||
88L3 | 50 | 3.47 | |||||
96 | 96L1 | 50 | 150 | 1.55 | 3.85 | ||
96L2 | 50 | 2.50 | |||||
96L3 | 50 | 7.51 | |||||
99 | 99L1 | 50 | 150 | 4.01 | 3.52 | ||
99L2 | 50 | 3.48 | |||||
99L3 | 50 | 3.09 | |||||
106 | 106L1 | 50 | 150 | 2.32 | 1.80 | ||
106L2 | 50 | 1.55 | |||||
106L3 | 50 | 1.53 | |||||
112 | 112L1 | 50 | 150 | 2.28 | 3.36 | ||
112L2 | 50 | 5.20 | |||||
112L3 | 50 | 2.59 | |||||
Potassium 3-sulphonatopropyl acrylate | 95 | 95L1 | 50 | 150 | 3.33 | 2.79 | 3.45 |
95L2 | 50 | 3.15 | |||||
95L3 | 50 | 1.91 | |||||
97 | 97L1 | 50 | 150 | 4.24 | 3.22 | ||
97L2 | 50 | 1.26 | |||||
97L3 | 50 | 4.17 | |||||
107 | 107L1 | 50 | 150 | 2.30 | 2.40 | ||
107L2 | 50 | 1.71 | |||||
107L3 | 50 | 3.21 | |||||
110 | 110L1 | 50 | 150 | 3.22 | 3.46 | ||
110L2 | 50 | 5.38 | |||||
110L3 | 50 | 1.79 | |||||
111 | 111L1 | 50 | 150 | 6.36 | 5.92 | ||
111L2 | 50 | 5.67 | |||||
111L3 | 50 | 5.73 | |||||
113 | 113L1 | 50 | 150 | 3.18 | 2.89 | ||
113L2 | 50 | 2.10 | |||||
113L3 | 50 | 3.39 |
SD : Standard deviation
NS : Statistically not significant (Dunnett’s Test)
Table 7: % Tail DNA, Medians per Slide, Mean Medians per Animal, per Dose (Liver) (continued)
Dose | Animal number | Slide code | Number of analysed cells/slide | Number of analysed cells/animal | % Tail DNA | ||
Per slide | Per animal | Per dose | |||||
(Median of 50 cells) | (Mean Median of 150 cells) | (Group Mean of 600 cells) | |||||
EMS | 93 | 93L1 | 50 | 150 | 12.39 | 13.35 | 13.20 |
93L2 | 50 | 14.39 | |||||
93L3 | 50 | 13.29 | |||||
102 | 102L1 | 50 | 150 | 20.69 | 17.42 | ||
102L2 | 50 | 15.97 | |||||
102L3 | 50 | 15.62 | |||||
104 | 104L1 | 50 | 150 | 10.63 | 10.47 | ||
104L2 | 50 | 11.16 | |||||
104L3 | 50 | 9.62 | |||||
114 | 114L1 | 50 | 150 | 11.32 | 11.58 | ||
114L2 | 50 | 12.88 | |||||
114L3 | 50 | 10.53 |
EMS : Ethyl methanesulfonate
SD : Standard deviation
** : Statistically significant (2-Sample T-test; α = 0.01)
Table 8: Tail Length and Olive Tail Moments (Mean Medians per Animal, per Dose, Stomach)
Dose | Animal number | Slide code | Tail Length (µm) | Olive Tail Moment | ||
Per animal | Per dose | Per animal | Per dose | |||
(Mean Median of 150 cells) | (Group Mean of 900 cells)1) | (Mean Median of 150 cells) | (Group Mean of 900 cells)1) | |||
Ultrapure water (ASTM Type I) x2 | 94 | 94S1 | 9.10 | 16.27 | 0.47 | 0.69 |
94S2 | ||||||
94S3 | ||||||
98 | 98S1 | 13.76 | 0.56 | |||
98S2 | ||||||
98S3 | ||||||
103 | 103S1 | 26.65 | 0.97 | |||
103S2 | ||||||
103S3 | ||||||
105 | 105S1 | 86.02# | 15.54# | |||
105S2 | ||||||
105S3 | ||||||
108 | 108S1 | 7.58 | 0.53 | |||
108S2 | ||||||
108S3 | ||||||
109 | 109S1 | 24.27 | 0.90 | |||
109S2 | ||||||
109S3 | ||||||
Potassium 3-sulphonatopropyl acrylate | 89 | 89S1 | 18.63 | 12.82 | 0.71 | 0.58 |
89S2 | ||||||
89S3 | ||||||
90 | 90S1 | 11.43 | 0.52 | |||
90S2 | ||||||
90S3 | ||||||
91 | 91S1 | 14.08 | 0.51 | |||
91S2 | ||||||
91S3 | ||||||
92 | 92S1 | 6.77 | 0.30 | |||
92S2 | ||||||
92S3 | ||||||
100 | 100S1 | 11.16 | 0.55 | |||
100S2 | ||||||
100S3 | ||||||
101 | 101S1 | 14.84 | 0.88 | |||
101S2 | ||||||
101S3 |
# : The animal coded “105” was excluded from the evaluation.
1) : In the case of ultrapure water vehicle control 750 cells/tissue
SD : Standard deviation
Table 8: Tail Length and Olive Tail Moments (Mean Medians per Animal, per Dose, Stomach) (continued)
Dose | Animal number | Slide code | Tail Length (µm) | Olive Tail Moment | ||
Per animal | Per dose | Per animal | Per dose | |||
(Mean Median of 150 cells) | (Group Mean of 900 cells) | (Mean Median of 150 cells) | (Group Mean of 900 cells) | |||
Potassium 3-sulphonatopropyl acrylate | 87 | 87S1 | 19.93 | 13.22 | 0.89 | 0.54 |
87S2 | ||||||
87S3 | ||||||
88 | 88S1 | 15.81 | 0.57 | |||
88S2 | ||||||
88S3 | ||||||
96 | 96S1 | 15.00 | 0.47 | |||
96S2 | ||||||
96S3 | ||||||
99 | 99S1 | 10.40 | 0.38 | |||
99S2 | ||||||
99S3 | ||||||
106 | 106S1 | 8.72 | 0.41 | |||
106S2 | ||||||
106S3 | ||||||
112 | 112S1 | 9.48 | 0.52 | |||
112S2 | ||||||
112S3 | ||||||
Potassium 3-sulphonatopropyl acrylate | 95 | 95S1 | 8.45 | 14.84 | 0.32 | 0.59 |
95S2 | ||||||
95S3 | ||||||
97 | 97S1 | 17.87 | 0.71 | |||
97S2 | ||||||
97S3 | ||||||
107 | 107S1 | 9.59 | 0.49 | |||
107S2 | ||||||
107S3 | ||||||
110 | 110S1 | 27.95 | 0.95 | |||
110S2 | ||||||
110S3 | ||||||
111 | 111S1 | 11.43 | 0.49 | |||
111S2 | ||||||
111S3 | ||||||
113 | 113S1 | 13.76 | 0.58 | |||
113S2 | ||||||
113S3 |
SD : Standard deviation
Table 8: Tail Length and Olive Tail Moments (Mean Medians per Animal, per Dose, Stomach) (continued)
Dose | Animal number | Slide code | Tail Length (µm) | Olive Tail Moment | ||
Per animal | Per dose | Per animal | Per dose | |||
(Mean Median of 150 cells) | (Group Mean of 600 cells) | (Mean Median of 150 cells) | (Group Mean of 600 cells) | |||
EMS | 93 | 93S1 | 71.66 | 49.26 | 5.82 | 4.63 |
93S2 | ||||||
93S3 | ||||||
102 | 102S1 | 42.90 | 3.34 | |||
102S2 | ||||||
102S3 | ||||||
104 | 104S1 | 41.82 | 3.72 | |||
104S2 | ||||||
104S3 | ||||||
114 | 114S1 | 40.68 | 5.63 | |||
114S2 | ||||||
114S3 |
EMS : Ethyl methanesulfonate
SD : Standard deviation
Table 9: Tail Length and Olive Tail Moments (Mean Medians per Animal, per Dose, Duodenum)
Dose | Animal number | Slide code | Tail Length (µm) | Olive Tail Moment | ||
Per animal | Per dose | Per animal | Per dose | |||
(Mean Median of 150 cells) | (Group Mean of 900 cells)1) | (Mean Median of 150 cells) | (Group Mean of 900 cells)1) | |||
Ultrapure water (ASTM Type I) x2 | 94 | 94D1 | 7.31 | 20.18 | 0.38 | 1.17 |
94D2 | ||||||
94D3 | ||||||
98 | 98D1 | 11.75 | 0.55 | |||
98D2 | ||||||
98D3 | ||||||
103 | 103D1 | 65.92 | 4.20 | |||
103D2 | ||||||
103D3 | ||||||
105 | 105D1 | 17.22# | 0.72# | |||
105D2 | ||||||
105D3 | ||||||
108 | 108D1 | 8.77 | 0.41 | |||
108D2 | ||||||
108D3 | ||||||
109 | 109D1 | 7.15 | 0.31 | |||
109D2 | ||||||
109D3 | ||||||
Potassium 3-sulphonatopropyl acrylate | 89 | 89D1 | 10.56 | 8.25 | 0.45 | 0.35 |
89D2 | ||||||
89D3 | ||||||
90 | 90D1 | 8.61 | 0.27 | |||
90D2 | ||||||
90D3 | ||||||
91 | 91D1 | 6.61 | 0.25 | |||
91D2 | ||||||
91D3 | ||||||
92 | 92D1 | 6.55 | 0.21 | |||
92D2 | ||||||
92D3 | ||||||
100 | 100D1 | 9.10 | 0.52 | |||
100D2 | ||||||
100D3 | ||||||
101 | 101D1 | 8.07 | 0.43 | |||
101D2 | ||||||
101D3 |
# : The animal coded “105” was excluded from the evaluation.
1) : In the case of ultrapure water vehicle control 750 cells/tissue
SD : Standard deviation
Table 9: Tail Length and Olive Tail Moments (Mean Medians per Animal, per Dose, Duodenum) (continued)
Dose | Animal number | Slide code | Tail Length (µm) | Olive Tail Moment | ||
Per animal | Per dose | Per animal | Per dose | |||
(Mean Median of 150 cells) | (Group Mean of 900 cells) | (Mean Median of 150 cells) | (Group Mean of 900 cells) | |||
Potassium 3-sulphonatopropyl acrylate | 87 | 87D1 | 8.45 | 12.53 | 0.34 | 0.47 |
87D2 | ||||||
87D3 | ||||||
88 | 88D1 | 7.20 | 0.22 | |||
88D2 | ||||||
88D3 | ||||||
96 | 96D1 | 16.79 | 0.54 | |||
96D2 | ||||||
96D3 | ||||||
99 | 99D1 | 17.11 | 0.51 | |||
99D2 | ||||||
99D3 | ||||||
106 | 106D1 | 8.83 | 0.45 | |||
106D2 | ||||||
106D3 | ||||||
112 | 112D1 | 16.79 | 0.80 | |||
112D2 | ||||||
112D3 | ||||||
Potassium 3-sulphonatopropyl acrylate | 95 | 95D1 | 7.42 | 11.91 | 0.27 | 0.62 |
95D2 | ||||||
95D3 | ||||||
97 | 97D1 | 29.79 | 1.68 | |||
97D2 | ||||||
97D3 | ||||||
107 | 107D1 | 8.61 | 0.39 | |||
107D2 | ||||||
107D3 | ||||||
110 | 110D1 | 8.34 | 0.48 | |||
110D2 | ||||||
110D3 | ||||||
111 | 111D1 | 9.32 | 0.43 | |||
111D2 | ||||||
111D3 | ||||||
113 | 113D1 | 8.01 | 0.48 | |||
113D2 | ||||||
113D3 |
SD : Standard deviation
Table 9: Tail Length and Olive Tail Moments (Mean Medians per Animal, per Dose, Duodenum) (continued)
Dose | Animal number | Slide code | Tail Length (µm) | Olive Tail Moment | ||
Per animal | Per dose | Per animal | Per dose | |||
(Mean Median of 150 cells) | (Group Mean of 600 cells) | (Mean Median of 150 cells) | (Group Mean of 600 cells) | |||
EMS | 93 | 93D1 | 51.18 | 37.64 | 4.28 | 3.26 |
93D2 | ||||||
93D3 | ||||||
102 | 102D1 | 32.01 | 2.19 | |||
102D2 | ||||||
102D3 | ||||||
104 | 104D1 | 33.64 | 2.57 | |||
104D2 | ||||||
104D3 | ||||||
114 | 114D1 | 33.74 | 3.97 | |||
114D2 | ||||||
114D3 |
EMS : Ethyl methanesulfonate
SD : Standard deviation
Table 10: Tail Length and Olive Tail Moments (Mean Medians per Animal, per Dose, Liver)
Dose | Animal number | Slide code | Tail Length (µm) | Olive Tail Moment | ||
Per animal | Per dose | Per animal | Per dose | |||
(Mean Median of 150 cells) | (Group Mean of 900 cells)1) | (Mean Median of 150 cells) | (Group Mean of 900 cells)1) | |||
Ultrapure water (ASTM Type I) x2 | 94 | 94L1 | 9.69 | 9.10 | 0.59 | 0.52 |
94L2 | ||||||
94L3 | ||||||
98 | 98L1 | 8.77 | 0.47 | |||
98L2 | ||||||
98L3 | ||||||
103 | 103L1 | 9.59 | 0.51 | |||
103L2 | ||||||
103L3 | ||||||
105 | 105L1 | 8.34# | 0.51# | |||
105L2 | ||||||
105L3 | ||||||
108 | 108L1 | 9.15 | 0.53 | |||
108L2 | ||||||
108L3 | ||||||
109 | 109L1 | 8.29 | 0.49 | |||
109L2 | ||||||
109L3 | ||||||
Potassium 3-sulphonatopropyl acrylate | 89 | 89L1 | 9.26 | 8.86 | 0.52 | 0.45 |
89L2 | ||||||
89L3 | ||||||
90 | 90L1 | 6.71 | 0.36 | |||
90L2 | ||||||
90L3 | ||||||
91 | 91L1 | 8.72 | 0.41 | |||
91L2 | ||||||
91L3 | ||||||
92 | 92L1 | 8.72 | 0.40 | |||
92L2 | ||||||
92L3 | ||||||
100 | 100L1 | 11.75 | 0.59 | |||
100L2 | ||||||
100L3 | ||||||
101 | 101L1 | 8.01 | 0.40 | |||
101L2 | ||||||
101L3 |
# : The animal coded “105” was excluded from the evaluation.
1) : In the case of ultrapure water vehicle control 750 cells/tissue
SD : Standard deviation
Table 10: Tail Length and Olive Tail Moments (Mean Medians per Animal, per Dose, Liver) (continued)
Dose | Animal number | Slide code | Tail Length (µm) | Olive Tail Moment | ||
Per animal | Per dose | Per animal | Per dose | |||
(Mean Median of 150 cells) | (Group Mean of 900 cells) | (Mean Median of 150 cells) | (Group Mean of 900 cells) | |||
Potassium 3-sulphonatopropyl acrylate | 87 | 87L1 | 8.29 | 8.36 | 0.43 | 0.38 |
87L2 | ||||||
87L3 | ||||||
88 | 88L1 | 8.50 | 0.41 | |||
88L2 | ||||||
88L3 | ||||||
96 | 96L1 | 8.56 | 0.44 | |||
96L2 | ||||||
96L3 | ||||||
99 | 99L1 | 9.59 | 0.42 | |||
99L2 | ||||||
99L3 | ||||||
106 | 106L1 | 7.04 | 0.23 | |||
106L2 | ||||||
106L3 | ||||||
112 | 112L1 | 8.18 | 0.36 | |||
112L2 | ||||||
112L3 | ||||||
Potassium 3-sulphonatopropyl acrylate | 95 | 95L1 | 7.63 | 8.12 | 0.34 | 0.40 |
95L2 | ||||||
95L3 | ||||||
97 | 97L1 | 6.77 | 0.33 | |||
97L2 | ||||||
97L3 | ||||||
107 | 107L1 | 6.50 | 0.27 | |||
107L2 | ||||||
107L3 | ||||||
110 | 110L1 | 7.91 | 0.38 | |||
110L2 | ||||||
110L3 | ||||||
111 | 111L1 | 11.16 | 0.65 | |||
111L2 | ||||||
111L3 | ||||||
113 | 113L1 | 8.77 | 0.42 | |||
113L2 | ||||||
113L3 |
SD : Standard deviation
Table 10: Tail Length and Olive Tail Moments (Mean Medians per Animal, per Dose, Liver) (continued)
Dose | Animal number | Slide code | Tail Length (µm) | Olive Tail Moment | ||
Per animal | Per dose | Per animal | Per dose | |||
(Mean Median of 150 cells) | (Group Mean of 600 cells) | (Mean Median of 150 cells) | (Group Mean of 600 cells) | |||
EMS | 93 | 93L1 | 32.77 | 31.81 | 1.77 | 2.05 |
93L2 | ||||||
93L3 | ||||||
102 | 102L1 | 35.97 | 2.82 | |||
102L2 | ||||||
102L3 | ||||||
104 | 104L1 | 32.55 | 1.73 | |||
104L2 | ||||||
104L3 | ||||||
114 | 114L1 | 25.94 | 1.87 | |||
114L2 | ||||||
114L3 |
EMS : Ethyl methanesulfonate
SD : Standard deviation
Table 11: Number and Percentage of Ghost Cells per Slide, per Animal, per Dose (Stomach)
Dose | Animal number | Slide code | Number of ghost cells / slide | Percentage of ghost cells / animal | Percentage of ghost cells / dose | Relative ratio of ghost cells compared to the control |
Ultrapure water (ASTM Type I) x2 | 94 | 94S1 | 8 | 12.71 | 10.58 | ‑ |
94S2 | 5 | |||||
94S3 | 9 | |||||
98 | 98S1 | 6 | 11.20 | |||
98S2 | 8 | |||||
98S3 | 5 | |||||
103 | 103S1 | 8 | 11.20 | |||
103S2 | 6 | |||||
103S3 | 5 | |||||
105 | 105S1 | 8 | 14.77# | |||
105S2 | 9 | |||||
105S3 | 9 | |||||
108 | 108S1 | 5 | 9.40 | |||
108S2 | 2 | |||||
108S3 | 9 | |||||
109 | 109S1 | 8 | 8.37 | |||
109S2 | 3 | |||||
109S3 | 3 | |||||
Potassium 3-sulphonatopropyl acrylate | 89 | 89S1 | 3 | 9.78 | 10.89 | 1.03 |
89S2 | 11 | |||||
89S3 | 3 | |||||
90 | 90S1 | 10 | 12.85 | |||
90S2 | 11 | |||||
90S3 | 2 | |||||
91 | 91S1 | 9 | 12.21 | |||
91S2 | 7 | |||||
91S3 | 5 | |||||
92 | 92S1 | 6 | 6.69 | |||
92S2 | 1 | |||||
92S3 | 4 | |||||
100 | 100S1 | 12 | 9.57 | |||
100S2 | 1 | |||||
100S3 | 4 | |||||
101 | 101S1 | 8 | 14.25 | |||
101S2 | 7 | |||||
101S3 | 10 |
# : The animal coded “105” was excluded from the evaluation.
SD : Standard deviation
NS : Statistically not significant (Dunnett’s Test)
Table 11: Number and Percentage of Ghost Cells per Slide, per Animal, per Dose (Stomach) (continued)
Dose | Animal number | Slide code | Number of ghost cells / slide | Percentage of ghost cells / animal | Percentage of ghost cells / dose | Relative ratio of ghost cells compared to the control |
Potassium 3-sulphonatopropyl acrylate | 87 | 87S1 | 3 | 9.03 | 12.53 | 1.18 |
87S2 | 6 | |||||
87S3 | 6 | |||||
88 | 88S1 | 9 | 13.25 | |||
88S2 | 6 | |||||
88S3 | 8 | |||||
96 | 96S1 | 8 | 15.71 | |||
96S2 | 10 | |||||
96S3 | 10 | |||||
99 | 99S1 | 10 | 10.93 | |||
99S2 | 7 | |||||
99S3 | 2 | |||||
106 | 106S1 | 10 | 14.21 | |||
106S2 | 6 | |||||
106S3 | 9 | |||||
112 | 112S1 | 4 | 12.05 | |||
112S2 | 6 | |||||
112S3 | 11 | |||||
Potassium 3-sulphonatopropyl acrylate | 95 | 95S1 | 10 | 15.66 | 12.10 | 1.14 |
95S2 | 7 | |||||
95S3 | 11 | |||||
97 | 97S1 | 8 | 12.62 | |||
97S2 | 4 | |||||
97S3 | 10 | |||||
107 | 107S1 | 7 | 12.78 | |||
107S2 | 8 | |||||
107S3 | 7 | |||||
110 | 110S1 | 11 | 9.78 | |||
110S2 | 3 | |||||
110S3 | 3 | |||||
111 | 111S1 | 6 | 12.70 | |||
111S2 | 10 | |||||
111S3 | 6 | |||||
113 | 113S1 | 3 | 9.03 | |||
113S2 | 6 | |||||
113S3 | 6 |
SD : Standard deviation
NS : Statistically not significant (Dunnett’s Test)
Table 11: Number and Percentage of Ghost Cells per Slide, per Animal, per Dose (Stomach) (continued)
Dose | Animal number | Slide code | Number of ghost cells / slide | Percentage of ghost cells / animal | Percentage of ghost cells / dose | Relative ratio of ghost cells compared to the control |
EMS | 93 | 93S1 | 16 | 24.23 | 22.97 | 2.17 |
93S2 | 15 | |||||
93S3 | 17 | |||||
102 | 102S1 | 10 | 19.10 | |||
102S2 | 17 | |||||
102S3 | 9 | |||||
104 | 104S1 | 10 | 23.20 | |||
104S2 | 18 | |||||
104S3 | 18 | |||||
114 | 114S1 | 18 | 25.34 | |||
114S2 | 23 | |||||
114S3 | 11 |
EMS : Ethyl methanesulfonate
SD : Standard deviation
** : Statistically significant (2-Sample T-test; α = 0.01)
Table 12: Number and Percentage of Ghost Cells per Slide, per Animal, per Dose (Duodenum)
Dose | Animal number | Slide code | Number of ghost cells / slide | Percentage of ghost cells / animal | Percentage of ghost cells / dose | Relative ratio of ghost cells compared to the control |
Ultrapure water (ASTM Type I) x2 | 94 | 94D1 | 7 | 11.76 | 11.06 | ‑ |
94D2 | 7 | |||||
94D3 | 6 | |||||
98 | 98D1 | 9 | 10.54 | |||
98D2 | 3 | |||||
98D3 | 6 | |||||
103 | 103D1 | 6 | 9.61 | |||
103D2 | 4 | |||||
103D3 | 6 | |||||
105 | 105D1 | 8 | 16.60# | |||
105D2 | 10 | |||||
105D3 | 12 | |||||
108 | 108D1 | 7 | 12.75 | |||
108D2 | 9 | |||||
108D3 | 6 | |||||
109 | 109D1 | 6 | 10.64 | |||
109D2 | 4 | |||||
109D3 | 8 | |||||
Potassium 3-sulphonatopropyl acrylate | 89 | 89D1 | 9 | 8.86 | 11.02 | 1.00 |
89D2 | 3 | |||||
89D3 | 3 | |||||
90 | 90D1 | 14 | 13.17 | |||
90D2 | 2 | |||||
90D3 | 8 | |||||
91 | 91D1 | 12 | 15.58 | |||
91D2 | 10 | |||||
91D3 | 6 | |||||
92 | 92D1 | 3 | 9.51 | |||
92D2 | 8 | |||||
92D3 | 5 | |||||
100 | 100D1 | 4 | 7.93 | |||
100D2 | 3 | |||||
100D3 | 6 | |||||
101 | 101D1 | 8 | 11.08 | |||
101D2 | 8 | |||||
101D3 | 3 |
# : The animal coded “105” was excluded from the evaluation.
SD : Standard deviation
NS : Statistically not significant (Dunnett’s Test)
Table 12: Number and Percentage of Ghost Cells per Slide, per Animal, per Dose (Duodenum) (continued)
Dose | Animal number | Slide code | Number of ghost cells / slide | Percentage of ghost cells / animal | Percentage of ghost cells / dose | Relative ratio of ghost cells compared to the control |
Potassium 3-sulphonatopropyl acrylate | 87 | 87D1 | 6 | 10.54 | 11.31 | 1.02 |
87D2 | 9 | |||||
87D3 | 3 | |||||
88 | 88D1 | 5 | 10.76 | |||
88D2 | 12 | |||||
88D3 | 2 | |||||
96 | 96D1 | 5 | 8.77 | |||
96D2 | 1 | |||||
96D3 | 9 | |||||
99 | 99D1 | 3 | 11.54 | |||
99D2 | 7 | |||||
99D3 | 10 | |||||
106 | 106D1 | 8 | 13.72 | |||
106D2 | 6 | |||||
106D3 | 10 | |||||
112 | 112D1 | 5 | 12.51 | |||
112D2 | 5 | |||||
112D3 | 12 | |||||
Potassium 3-sulphonatopropyl acrylate | 95 | 95D1 | 9 | 13.74 | 12.54 | 1.13 |
95D2 | 6 | |||||
95D3 | 9 | |||||
97 | 97D1 | 9 | 11.45 | |||
97D2 | 2 | |||||
97D3 | 9 | |||||
107 | 107D1 | 4 | 11.65 | |||
107D2 | 7 | |||||
107D3 | 9 | |||||
110 | 110D1 | 6 | 13.48 | |||
110D2 | 5 | |||||
110D3 | 13 | |||||
111 | 111D1 | 9 | 12.71 | |||
111D2 | 5 | |||||
111D3 | 8 | |||||
113 | 113D1 | 9 | 12.21 | |||
113D2 | 5 | |||||
113D3 | 7 |
SD : Standard deviation
NS : Statistically not significant (Dunnett’s Test)
Table 12: Number and Percentage of Ghost Cells per Slide, per Animal, per Dose (Duodenum) (continued)
Dose | Animal number | Slide code | Number of ghost cells / slide | Percentage of ghost cells / animal | Percentage of ghost cells / dose | Relative ratio of ghost cells compared to the control |
EMS | 93 | 93D1 | 23 | 27.04 | 20.81 | 1.88 |
93D2 | 16 | |||||
93D3 | 17 | |||||
102 | 102D1 | 16 | 19.65 | |||
102D2 | 10 | |||||
102D3 | 11 | |||||
104 | 104D1 | 16 | 21.33 | |||
104D2 | 15 | |||||
104D3 | 10 | |||||
114 | 114D1 | 8 | 15.24 | |||
114D2 | 10 | |||||
114D3 | 9 |
EMS : Ethyl methanesulfonate
SD : Standard deviation
** : Statistically significant (2-Sample T-test; α = 0.01)
Table 13: Number and Percentage of Ghost Cells per Slide, per Animal, per Dose (Liver)
Dose | Animal number | Slide code | Number of ghost cells / slide | Percentage of ghost cells / animal | Percentage of ghost cells / dose | Relative ratio of ghost cells compared to the control |
Ultrapure water (ASTM Type I) x2 | 94 | 94L1 | 1 | 2.59 | 3.56 | ‑ |
94L2 | 1 | |||||
94L3 | 2 | |||||
98 | 98L1 | 2 | 2.56 | |||
98L2 | 0 | |||||
98L3 | 2 | |||||
103 | 103L1 | 2 | 2.59 | |||
103L2 | 1 | |||||
103L3 | 1 | |||||
105 | 105L1 | 3 | 3.17# | |||
105L2 | 0 | |||||
105L3 | 2 | |||||
108 | 108L1 | 4 | 6.24 | |||
108L2 | 3 | |||||
108L3 | 3 | |||||
109 | 109L1 | 2 | 3.82 | |||
109L2 | 1 | |||||
109L3 | 3 | |||||
Potassium 3-sulphonatopropyl acrylate | 89 | 89L1 | 2 | 6.78 | 3.76 | 1.05 |
89L2 | 5 | |||||
89L3 | 4 | |||||
90 | 90L1 | 3 | 5.01 | |||
90L2 | 4 | |||||
90L3 | 1 | |||||
91 | 91L1 | 1 | 3.22 | |||
91L2 | 2 | |||||
91L3 | 2 | |||||
92 | 92L1 | 4 | 3.75 | |||
92L2 | 0 | |||||
92L3 | 2 | |||||
100 | 100L1 | 1 | 0.65 | |||
100L2 | 0 | |||||
100L3 | 0 | |||||
101 | 101L1 | 0 | 3.12 | |||
101L2 | 4 | |||||
101L3 | 1 |
# : The animal coded “105” was excluded from the evaluation.
SD : Standard deviation
NS : Statistically not significant (Dunnett’s Test)
Table 13: Number and Percentage of Ghost Cells per Slide, per Animal, per Dose (Liver) (continued)
Dose | Animal number | Slide code | Number of ghost cells / slide | Percentage of ghost cells / animal | Percentage of ghost cells / dose | Relative ratio of ghost cells compared to the control |
Potassium 3-sulphonatopropyl acrylate | 87 | 87L1 | 5 | 6.80 | 3.74 | 1.05 |
87L2 | 3 | |||||
87L3 | 3 | |||||
88 | 88L1 | 6 | 6.69 | |||
88L2 | 4 | |||||
88L3 | 1 | |||||
96 | 96L1 | 2 | 1.94 | |||
96L2 | 0 | |||||
96L3 | 1 | |||||
99 | 99L1 | 1 | 1.31 | |||
99L2 | 0 | |||||
99L3 | 1 | |||||
106 | 106L1 | 0 | 1.28 | |||
106L2 | 0 | |||||
106L3 | 2 | |||||
112 | 112L1 | 1 | 4.43 | |||
112L2 | 3 | |||||
112L3 | 3 | |||||
Potassium 3-sulphonatopropyl acrylate | 95 | 95L1 | 1 | 2.59 | 2.97 | 0.83 |
95L2 | 1 | |||||
95L3 | 2 | |||||
97 | 97L1 | 1 | 3.19 | |||
97L2 | 3 | |||||
97L3 | 1 | |||||
107 | 107L1 | 2 | 5.06 | |||
107L2 | 3 | |||||
107L3 | 3 | |||||
110 | 110L1 | 0 | 1.94 | |||
110L2 | 1 | |||||
110L3 | 2 | |||||
111 | 111L1 | 0 | 1.28 | |||
111L2 | 2 | |||||
111L3 | 0 | |||||
113 | 113L1 | 4 | 3.75 | |||
113L2 | 2 | |||||
113L3 | 0 |
SD : Standard deviation
NS : Statistically not significant (Dunnett’s Test)
Table 13: Number and Percentage of Ghost Cells per Slide, per Animal, per Dose (Liver) (continued)
Dose | Animal number | Slide code | Number of ghost cells / slide | Percentage of ghost cells / animal | Percentage of ghost cells / dose | Relative ratio of ghost cells compared to the control |
EMS | 93 | 93L1 | 3 | 6.80 | 7.37 | 2.07 |
93L2 | 3 | |||||
93L3 | 5 | |||||
102 | 102L1 | 4 | 6.24 | |||
102L2 | 3 | |||||
102L3 | 3 | |||||
104 | 104L1 | 3 | 6.83 | |||
104L2 | 4 | |||||
104L3 | 4 | |||||
114 | 114L1 | 6 | 9.61 | |||
114L2 | 4 | |||||
114L3 | 6 |
EMS : Ethyl methanesulfonate
SD : Standard deviation
** : Statistically significant (2-Sample T-test; α = 0.01)
Table 14: Historical Control Data for Stomach Cells (C-Charts)
| Historical control data for stomach cells (C-chart) | ||
Negative (vehicle) control | |||
% DNA in Tail | Tail length | OTM | |
Mean | 10.70 | 41.51 | 3.42 |
Lower confidence interval | 5.91 | 12.47 | 0.88 |
Upper confidence interval | 15.49 | 70.56 | 5.96 |
SD | 1.86 | 11.30 | 0.99 |
n | 6 | 6 | 6 |
| Historical control data for stomach cells (C-chart) | ||
Positive control (Ethyl methanesulfonate) | |||
% DNA in Tail | Tail length | OTM | |
Mean | 31.29 | 98.01 | 13.75 |
Lower confidence interval | 22.20 | 45.65 | 1.41 |
Upper confidence interval | 40.38 | 150.37 | 26.08 |
SD | 4.02 | 23.15 | 5.46 |
n | 10 | 10 | 10 |
OTM : Olive Tail Moment=(Tail.mean - Head.mean) x Tail%DNA/100
SD : Standard deviation
Table 15: Historical Control Data for Duodenum Cells (C-Charts)
| Historical control data for duodenum cells (C-chart) | ||
Negative (vehicle) control | |||
% DNA in Tail | Tail length | OTM | |
Mean | 9.94 | 31.90 | 1.39 |
Lower confidence interval | 0.38 | 0.00 | 0.00 |
Upper confidence interval | 19.49 | 66.61 | 6.04 |
SD | 4.04 | 14.68 | 1.39 |
n | 8 | 8 | 8 |
| Historical control data for duodenum cells (C-chart) | ||
Positive control (Ethyl methanesulfonate) | |||
% DNA in Tail | Tail length | OTM | |
Mean | 30.17 | 90.35 | 12.24 |
Lower confidence interval | 15.27 | 30.61 | 4.02 |
Upper confidence interval | 45.08 | 150.08 | 20.47 |
SD | 6.09 | 24.41 | 3.36 |
n | 7 | 7 | 7 |
n : number of experiments
OTM : Olive Tail Moment=(Tail.mean - Head.mean) x Tail%DNA/100
SD : Standard deviation
Remark: At the C-chart calculations in the case of negative control the results of eight experiments were taken into consideration. The lower confidence interval at tail length and OTM parameters, due to the nature of these calculations, was negative. Instead of the negative value zero was incorporated into the tables.
Table 16: Historical Control Data for Liver Cells (C-Charts)
| Historical control data for liver cells (C-chart) | ||
Negative (vehicle) control | |||
% DNA in Tail | Tail length | OTM | |
Mean | 6.58 | 25.48 | 1.93 |
Lower confidence interval | 3.64 | 5.01 | 0.77 |
Upper confidence interval | 9.52 | 45.95 | 3.08 |
SD | 1.27 | 8.88 | 0.50 |
n | 9 | 9 | 9 |
| Historical control data for liver cells (C-chart) | ||
Positive control (Ethyl methanesulfonate) | |||
% DNA in Tail | Tail length | OTM | |
Mean | 23.36 | 87.77 | 9.19 |
Lower confidence interval | 12.80 | 42.86 | 2.05 |
Upper confidence interval | 33.92 | 132.68 | 16.33 |
SD | 4.67 | 19.85 | 3.16 |
n | 10 | 10 | 10 |
n : number of experiments
OTM : Olive Tail Moment=(Tail.mean - Head.mean) x Tail%DNA/100
SD : Standard deviation
Table 17: Laboratory’s Historical Control Ranges for Percentages of Ghost Cells
| Negative (vehicle) control | ||
Stomach | Duodenum | Liver | |
Mean | 10 % | 9 % | 4 % |
Minimum | 9 % | 7 % | 1 % |
Maximum | 11 % | 11 % | 9 % |
SD | 1.16 | 1.51 | 2.59 |
n | 6 | 8 | 9 |
| Positive control (Ethyl methanesulfonate) | ||
Stomach | Duodenum | Liver | |
Mean | 20 % | 21 % | 10 % |
Minimum | 12 % | 7 % | 5 % |
Maximum | 30 % | 28 % | 31 % |
SD | 4.87 | 7.56 | 7.66 |
n | 10 | 7 | 10 |
n : number of experiments
SD : Standard deviation
Applicant's summary and conclusion
- Conclusions:
- The investigated test item did not show genotoxic activity in the examined tissues in this Comet Assay.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.