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EC number: 258-004-5 | CAS number: 52556-42-0
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 April - 13. July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium 3-(allyloxy)-2-hydroxypropanesulphonate
- EC Number:
- 258-004-5
- EC Name:
- Sodium 3-(allyloxy)-2-hydroxypropanesulphonate
- Cas Number:
- 52556-42-0
- Molecular formula:
- C6H12O5S.Na
- IUPAC Name:
- sodium 2-hydroxy-3-(prop-2-en-1-yloxy)propane-1-sulfonate
- Reference substance name:
- Sodium hydroxide
- EC Number:
- 215-185-5
- EC Name:
- Sodium hydroxide
- Cas Number:
- 1310-73-2
- Molecular formula:
- HNaO
- IUPAC Name:
- sodium hydroxide
- Reference substance name:
- 3-(allyloxy)propane-1,2-diol
- EC Number:
- 204-620-4
- EC Name:
- 3-(allyloxy)propane-1,2-diol
- Cas Number:
- 123-34-2
- Molecular formula:
- C6H12O3
- IUPAC Name:
- 3-(allyloxy)propane-1,2-diol
- Reference substance name:
- disodium 2-hydroxy-3-(3-sulfonatopropoxy)propane-1-sulfonate
- Molecular formula:
- C6H12Na2O8S2
- IUPAC Name:
- disodium 2-hydroxy-3-(3-sulfonatopropoxy)propane-1-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- light yellow powder
Constituent 1
additive 1
impurity 1
impurity 2
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Vehicle:
- water
- Control samples:
- yes, concurrent negative control
- yes, concurrent vehicle
- yes, concurrent positive control
- Duration of treatment / exposure:
- 3 minutes
- Number of replicates:
- 2
Test system
- Amount / concentration applied:
- 25 mg in 25 µl water
- Duration of treatment / exposure:
- 3 min, 60 min
- Details on study design:
- Preparations:
On the day of the start of the experiment, the MTT concentrate was thawed. The concentrate was diluted with the MTT solvent and the solution was stored at 4°C in the dark. The tissue plate was brought out of the fridge one hour before the treatment. The assay medium was wamed in the water bath to 37 °C.
Description ot the method
Four 6-well-plates were prepared with 0.9 l assay medium in each well. The inserts containing the tissues were transferred to the wells using sterile forceps and the 6-well-plates were set into the incubator at 37 °C and 5 % CO2 for one hour (pre-incubation).
For each experiment ("three minutes" and "one hour"), two 6-well-plates were used. After preincubation, the assay medium was replaced by fresh assay medium and the test was started, using two wells as negative control with 50 µl H2O demin., two wells as positive controls with 50 µL potassium hydroxide solution and two other wells for testing the test item. The solid test item was ground, and 25 mg test item were applied together with 25 µL H2O. At the start of each experiment (application of negative controls), a stop watch was started.
After the respective incubation time (three minutes +- 10 sec and one hour), the inserts were removed from the plates using sterile forceps. The inserts were thoroughly rinsed with PBS, blotted with sterile cellulose tissue and set into the respective holding plate, using the wells containing assay medium. After transfer of all inserts, they were immediately moved to the wells containing MTT reagen, blotting the bottom with cellulose tissue again before setting the insert into the MTT well. The tissues were incubated with MTT reagent for three hours. After this time, the MTT reagent was aspirated and replaced by PBS buffer. This was then aspirated, too, and replaced several times. At last, each insert was thoroughly dried and set into the empty, pre-warmed 24-well-plate. Into each well, 2 mL isopropanole werepipetted, taking careto reach the upper rim of the insert. The plate was then covered with Parafilm and left to stand over night at room temperature.
On the next day, the inserts in which formazan had been produced over night were pierced with an injection needle, taking care that all colour was extracted. the inserts were then discarded and the content of each well was thoroughly mixed in order to achieve homogenisation.
From each well, three replicates with 200 µL solution (each) were pipetted into a 96-wll-plate which was read in a plate spectral photometer at 570 nm.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 81.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Measured Values
see table in "any other information"
Comparison of Formazan Production
3 min Incubation time: 81.9 % (test item); 20.2 % (Positive control)
60 min Incubation time: 42.6 % (test item); 10.2 % (Positive control)
Assessment:
The relative absorbance values were reduced to 81.9 % after three minutes treatment. This value is above the threshold for corrosivity (50 %). After one hour treatment, the relative absorbance values were reduced to 42.6 %, lying above the threshold for corrosivity (15%).
Therefore, the test item is considered as not corrosive.
Any other information on results incl. tables
Measured Values
The absorption values of negative control, test item and positive control are given in the following table:
Absorption Values
Negative Control |
Test Item |
Positive Control |
Incubation |
|||
Tissue 1 |
Tissue 2 |
Tissue 1 |
Tissue 2 |
Tissue 1 |
Tissue 2 |
|
2.465 |
2.253 |
1.938 |
1.954 |
0.552 |
0.383 |
3 min |
2.388 |
2.351 |
1.977 |
1.865 |
0.540 |
0.422 |
|
2.407 |
2.267 |
1.927 |
1.912 |
0.541 |
0.419 |
|
2.199 |
2.200 |
0.941 |
0.930 |
0.224 |
0.231 |
1 hour |
2.222 |
2.217 |
0.950 |
0.926 |
0.219 |
0.243 |
|
2.125 |
2.226 |
0.939 |
0.929 |
0.219 |
0.213 |
|
Mean |
Mean |
Mean |
|
|||
2.355 |
1.929 |
0.476 |
3 min |
|||
2.198 |
0.936 |
0.225 |
1 hour |
Comparison of Formazan Production
For the test item and the positive control, the following percentage values of mean formazan production were calculated in comparison to the mean of the negative controls:
% Formazan Production
Test Item |
Positive Control |
Incubation |
81.9% |
20.2% |
3 min |
42.6% |
10.2% |
1 hour |
Corrosivity of the Test Item
The relative absorbance values were reduced to 81.9% after three minutes treatment. This value is above the threshold for corrosivity (50%). After one hour treatment, the relative absorbance values were reduced to 42.6 %, lying above the threshold for corrosivity (15%). Therefore, the test item is considered as not corrosive.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The study is well performed and gives following results for the Endpoint:
not corrosive - Executive summary:
Two tissues of the human skin model EpiDermTMwere treated with sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) for three minutes and one hour, respectively. In average, 25.2 mg of the solid test item were applied to each tissue and spread to match the tissue size.
Deionised water was used as negative control, 8m KOH was used as positive control.
After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT which can be reduced to a blue formazan. Formazan production was measured by measuring the optical density (OD) of the resulting solution.
After treatment with the negative control, the absorbance values were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus showing the quality of the tissues. The positive control showed clear corrosive effects for both treatment intervals.
After three minutes treatment with the test item, the relative absorbance values were reduced to 81.9 %. This value is well above the threshold for corrosion potential (50%). After one hour treatment, relative absorbance values were reduced to 42.6 %. This value, too, is well above the threshold for corrosion potential (15%). In the guideline, values greater or equal to the threshold are considered as “non-corrosive to skin”.
Therefore, sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) is considered as
not corrosive in the Human Skin Model Test.
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