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EC number: 931-259-6 | CAS number: -
- 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:
- 26.06. - 07.09.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- Version / remarks:
- adopted 29 July 2016
- Deviations:
- yes
- Remarks:
- See Any other information
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian comet assay
Test material
- Reference substance name:
- SDA Product (desulphurization of exhaust gases by semi-dry absorption method from the coal fired power plants)
- EC Number:
- 931-259-6
- Molecular formula:
- Not available
- IUPAC Name:
- SDA Product (desulphurization of exhaust gases by semi-dry absorption method from the coal fired power plants)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Product of Semi-Dry Absorption method of Flue Gas Desulphurization (SDA Product)
- Molecular formula (if other than submission substance): not available
- Molecular weight (if other than submission substance): not available
Composition of test substance
CaSO4*H2O 27.46 %
CaCO3 10.48 %
CaSO3*1/2H2O 34.83 %
CaCl2*2H2O 15.30 %
CaF2 0.62 %
Ca(OH)2 7.78 %
CaO free 5.89 %
Loss by ignition 10.67 %
Sum of toxic metals
(As, Ba, Cd, Co, Cr, Cu, Hg, Mo, Ni, Pb, Sb, Se, Te, Ti, V, Zn)….< 0.1 %
Batch No.: SDA 13.12.16 SKW
Appearance: light grey solid powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld , Germany
- Age at study initiation: 7 to 9 weeks
- Weight at study initiation: 210 - 300 g
- Assigned to test groups randomly: yes
- Fasting period before study: not specified
- Housing: The animals were kept in groups of 2 - 3 by sex in MAKROLON cages (type III plus). Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages. The cages were changed and cleaned twice a week.
- Diet: ad libitum
- Water: ad libitum
Certificates of analysis of diet, drinking water and bedding material are QAU archived.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 10%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): The rooms were lit (about 150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: 0.8% aqueous hydroxypropylmethylcellulose - Methocel, batch no. 13D03-N03, Fagron GmbH & Co. KG, 22885 Barsbüttel, Germany
- Justification for choice of solvent/vehicle: 0.8% aqueous hydroxypropylmethylcellulose was chosen as vehicle as it is known not to produce any toxic effects according to known available information. - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Product of Semi-Dry Absorption method of Flue Gas Desulphurization (SDA Product) was suspended in 0.8% aqueous hydroxypropylmethylcellulose. The administration volume was 20 mL/kg b.w.
In line with normal practice in this type of in vivo study, no analysis of the dose form is required. A test on stability and homogeneity was not necessary as the test item formulation was prepared immediately before administration. - Duration of treatment / exposure:
- 45
- Frequency of treatment:
- Three times at 0, 24 and 45 hours
- Post exposure period:
- 3 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- vehicle control
- Dose / conc.:
- 400 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5 animals
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- ethylmethanesulphonate
- Justification for choice of positive control(s): not specified, it is an example of positive control substance from OECD 489 for any tissue
- Route of administration: oral by gavage, administered two times at 24 and 45 hours
- Doses / concentrations: 250 mg/kg b.w./day
Examinations
- Tissues and cell types examined:
- liver, stomach and duodenum cells
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
The dose levels for the main study had been selected based on the results of a preliminary dose-range-finding study of 250, 500, 1000 and 2000 mg/kg b.w./day, p.o. employing two animals per dose. No signs of systemic toxicity were noted up to the highest dose level of 2000 mg/kg b.w./day, p.o.
All groups were used for the sampling. The highest dose for the comet assay is defined as the dose producing signs of toxicity such that higher dose levels, based on the same dosing regimen, would be expected to produce lethality.
As no toxicity occurred the highest reasonable dose level of 2000 mg/kg b.w. was employed.
In line with normal practice in this type of in vivo study, no analysis of the dose form is required.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
Animals were treated with the test item at three intervals of 0, 24 and 45 hours and tissues (liver, stomach and duodenum) were sampled at 48 hours (3 hours after the last dose) in order to accommodate the sampling requirements of the comet assay.
Treatment with the positive reference item was performed twice: 0 and 21 hours (3 hours before sampling).
DETAILS OF SLIDE PREPARATION:
For the preparation of slides the CometAssay® HT Kit (Trevigen) was used according to the manufacturer´s instructions. Each cell suspension was mixed 1:10 with low-melting agarose. An adequate amount of the cell-agarose mixture was applied to two wells of the 20-well microscope slide. The preparation of the slides was completed within two (2) hours after sacrifice.
The prepared slides were incubated in a lysis buffer overnight at +2°C to +8°C. After incubation, the slides were incubated in freshly prepared alkaline unwinding solution (pH>13) for 20 minutes at room temperature.
METHOD OF ANALYSIS:
The slides were analysed by epifluorescence microscopy at 200 x magnification. At least 150 liver, stomach and duodenum cells per animal and tissue were evaluated using the Comet Assay IV software (Perceptive Instruments Ltd).
All slides for analysis, including those of positive and negative controls were independently coded. - Evaluation criteria:
- Percent tail DNA (% tail intensity) was determined to assess DNA damage. The DNA fragment intensity in the tail was expressed as a percentage of the cell's total intensity. The median % tail DNA for each animal was calculated. The mean of the individual animal’s median was then determined.
Only cells of good morphology (clearly defined head and tail with no interference with neighbouring cells) were scored for % tail DNA. Artefacts were avoided. The occurrence of hedgehogs was determined based on the visual scoring and tabulated but not evaluated and reported. - Statistics:
- Generally, means and standard deviations were calculated. Intergroup comparisons with the control group were made by an analysis of variance (ANOVA) followed by the DUNNETT multiple comparison test7 (p ≤ 0.05 and p ≤ 0.01). A square root transformation of the data was needed because of the high standard deviation. The positive control data were compared to the values of the vehicle control group values by unpaired Student's t-test (t)8 (normal distribution) (WILCOXON MANN-WHITNEY Test with StatXact 49 (not normal distributed). Significantly different data were indicated in the tables of the report. A possible dose-response-relationship was examined by linear regression analysis employing PEARSON's correlation coefficient.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The details of the results, historical control data and preliminary dose-range-finding study - see attached documents.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, under the present test conditions Product of Semi-Dry Absorption method of Flue Gas Desulphurization (SDA Product) tested up to the highest reasonable dose level of 2000 mg/kg b.w. per day by repeated oral administration for three days showed no genotoxic properties in the in vivo alkaline comet (single cell gel electrophoresis) assay employing liver, stomach and duodenum cells. In the same system, ethyl methane sulfonate (positive reference item) induced significant damage.
- Executive summary:
Product of Semi-Dry Absorption method of Flue Gas Desulphurization (SDA Product) was assayed in an in vivo alkaline comet (single cell gel electrophoresis) assay for the detection of DNA strand breaks in cells or nuclei isolated from liver, stomach and duodenum, tissues of male CD rats. The test item was administered orally to rats once daily for three days at 0, 24 and 45 hours, and liver, stomach and duodenum tissues were sampled at 48 hours (3 hours after the last dose).
Product of Semi-Dry Absorption method of Flue Gas Desulphurization (SDA Product) was suspended in 0.8% aqueous hydroxypropylmethylcellulose. The dose levels for the main study had been selected based on the results of a preliminary dose-range-finding study of 250, 500, 1000 and 2000 mg/kg b.w./day, p.o employing two animals per dose. No signs of systemic toxicity were noted up to the highest dose level of 2000 mg/kg b.w./day, p.o.
Three ascending dose levels of 400, 1000 or 2000 mg Product of Semi-Dry Absorption method of Flue Gas Desulphurization (SDA Product)/kg b.w./day, p.o. and the vehicle (0.8% aqueous hydroxypropylmethylcellulose) were administered three times at 0, 24 and 45 hours. The positive reference item (250 mg ethyl methane sulfonate/kg b.w./day, p.o.) was administered two times at 24 and 45 hours. Each group consisted of 5 male rats. The administration volume was 20 mL/kg b.w./day.
No signs of systemic toxicity were noted up to the highest dose level of 2000 mg Product of Semi-Dry Absorption method of Flue Gas Desulphurization (SDA Product)/kg b.w./day, p.o.
150 liver, stomach and duodenum cells per animal and tissue collected 48 hours post 1st administration were evaluated. The grade of DNA fragmentation is expressed in percent tail DNA (% tail intensity).
Treatment with Product of Semi-Dry Absorption method of Flue Gas Desulphurization (SDA Product) did not increase the tail intensity for the liver, stomach and duodenum cells at any of the three tested dose levels of 400, 1000 or 2000 mg test item/kg b.w./day compared to the vehicle control data. The vehicle results were within the historical control ranges. Administration of ethyl methane sulfonate (positive reference) significantly increased the % tail intensity of liver, stomach and duodenum cells. Therefore, the test is considered valid.
In conclusion, under the present test conditions Product of Semi-Dry Absorption method of Flue Gas Desulphurization (SDA Product) tested up to the highest reasonable dose level of 2000 mg/kg b.w. per day by repeated oral administration for three days showed no genotoxic properties in the in vivo alkaline comet (single cell gel electrophoresis) assay employing liver, stomach and duodenum cells.
In the same system, ethyl methane sulfonate (positive reference item) induced significant damage.
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