Registration Dossier
Registration Dossier
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: 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

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15.10 - 16.10.2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Ocular Irritation Protocol: Neat Method (MTT ET-50), Rev. 1/1/01 (1)
- Deviations:
- yes
- Remarks:
- This deviation had no impact on the outcome of the study.
- GLP compliance:
- yes
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): Semi Dry Absorption (SDA) Product
- Molecular formula (if other than submission substance): not available
- Molecular weight (if other than submission substance): not available
Composition of test substance:
Calcium sulphate 6.49 %
Calcium sulphite 41.40 %
Calcium carbonate 29.50 %
Calcium hydroxide 2.27 %
Calcium chloride 17.98 %
Calcium fluoride 0.57 %
Oxides (SiO2 + Al2O3 + Fe2O3 + TiO2) sum 0.97 %
Sum of toxic metals: As, Be, Cd, Co, Cr, Cu, Hg, Mo, Ni, Pb, Sb, Se, Tl, V, Zn sum < 0.1 %
Batch No.: SDA/0609/Sk
Appearance: White solid powder
Stability / Expiration date: 15 years (06/2024)
- Stability under test conditions: stable
- Storage condition of test material: the substance was stored in PE container at room temperature.
- Other: pH 11 approx. (by contact of application form with universal indicator pH strip moistened with water, strip producer Lach-Ner, s.r.o. Neratovice)
Constituent 1
Test system
- Amount / concentration applied:
- TEST MATERIAL
As the test substance is partially soluble it could not be applied as a paste. First, tissues were moistened with 100 µL of H2O for injection before layering the test substance on its surface. At application it was assured, so the tissues were completely covered by the test substance.
- Duration of treatment / exposure:
- 3, 30, 60 mins
Results and discussion
In vitro
Results
- Irritation parameter:
- other: ET-50
- Remarks:
- 1370.0
- Value:
- 1 370
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Direct MTT reduction
Before the test itself, direct MTT reduction was assayed.
After 60 min incubation of the test substance with MTT medium no changes in colouring were observed compared with concurrent control without test substance.
The test substance did not reduce MTT directly.
MTT test
OD570measuring was performed after overnight extraction. Results are given in the following table and figure.
Table No. 2: Results of the MTT test
time |
|
treatment |
OD570values |
mean |
SD |
Inter tissue variability limits |
% NC |
|||
|
|
|
1 |
2 |
3 |
|
|
|
||
|
NC |
water |
1.757 |
1.503 |
1.690 |
1.650 |
0.107 |
1.403 |
1.898 |
100.0 |
3 min |
C1 |
67/09 |
1.481 |
1.330 |
1.290 |
1.367 |
0.082 |
1.162 |
1.572 |
82.8 |
30 min |
C1 |
67/09 |
1.248 |
1.175 |
1.087 |
1.170 |
0.066 |
0.995 |
1.346 |
70.9 |
60 min |
C1 |
67/09 |
1.061 |
1.135 |
0.358 |
1.098 |
0.350 |
0.933 |
1.263 |
66.5 |
15 min |
PC |
0.3% Triton X-100 |
1.028 |
1.126 |
1.223 |
1.126 |
0.080 |
0.957 |
1.295 |
68.2 |
45 min |
PC |
0.3% Triton X-100 |
0.401 |
0.265 |
0.278 |
0.315 |
0.061 |
0.267 |
0.362 |
19.1 |
NC |
negative control |
PC |
positive control |
C1 |
test substance |
mean |
arithmetic mean |
% NC |
viability of single tissues compared with negative control |
SD |
standard deviation of OD570values |
0.358 |
value excluded according to the rules |
Accuracy criteria fulfilment
Negative Control: criterion was fulfilled
Positive Control: criterion was fulfilled
Inter tissue viability difference:
One tissue treated with the test substance for 60 min had lower OD570 than the other two tissues. After administration, this tissue was also detached from base and rolled up (see primary data). This OD570value did not fulfil the criterion of being in the interval of mean value±15%, so it was excluded from evaluation.
Interval among positive control tissues after 45 min treatment was higher than ±15%. It was caused by damage of tissues after positive control treatment. At comparison of ET-50 values with and without an outlying value it was found out, that ET-50 would changed from 22.54 to 22.08 min, what are very close values and both belong into acceptability interval.
Evaluation of result
As it is possible to see from the results given above, average viabilities of affected tissues are 82.8% after 3 minutes of treatment,70.9% after 30 min and 66.5% after 60 min of administration. So, viability decreases slightly with time and value of ET-50 calculated is 1369.98 min. According to the Table 1, it responses to the Draize score 0-15 and to theto the Kay and Calandra classification category non-irritating.Applicant's summary and conclusion
- Conclusions:
- Under the above-described experimental design, the test substance Semi Dry Absorption (SDA) Product was non irritating for EpiOcularTM tissues.
- Executive summary:
Test substance Semi Dry Absorption (SDA) Product was assayed for the in vitro eye irritation in human corneal model EpiOcularTM. The test was performed according to MatTekOcular Irritation Protocol: Neat Method (MTT ET-50),Rev. 1/1/01 (1).
The test substance was applied in delivered form onto a tissue moistened with water. Length of exposition was 3, 30 and 60 minutes. Three tissues were used for each time interval, six for positive control (PC) and three for negative control (NC).
After rinsing and soaking in medium, tissues were incubated with MTT for three hours and then extracted overnight without shaking. OD570 of isopropanol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each three tissues as % of the mean viability of the negative control. A chart of semi-log scale - the % viability (linear y axis) versus the dosing time (log x axis) was constructed and ET-50 value was calculated from slope of the line obtained. The ET-50 calculated was 1369.98 min. It responses to the Draize score 0 - 15 and to the Kay and Calandra classification category non-irritant.
In the experiment arrangement given above, the test substance Semi Dry Absorption (SDA) Product was non irritating in EpiOcularTMmodel.
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.
