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Diss Factsheets
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EC number: - | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 August - 21 August 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 18 June 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of (Tetramethylcyclotetrasiloxane propylether) prop-1-enylether bisphenol A and Di(tetramethylcyclotetrasiloxane propylether) bisphenol A
- Cas Number:
- 203874-34-4
- Molecular formula:
- (OSiHxCH3)4-CH2-CH2 -CH2- O-C6H4-C(CH3)2-C6H4-0-CH2-CH2-CH2-(SiHxCH3O)4
- IUPAC Name:
- Reaction mass of (Tetramethylcyclotetrasiloxane propylether) prop-1-enylether bisphenol A and Di(tetramethylcyclotetrasiloxane propylether) bisphenol A
- Test material form:
- liquid
- Details on test material:
- Appearance: Pale yellow liquid
Constituent 1
- Specific details on test material used for the study:
- Storage Conditions: Room temperature in the dark, under nitrogen.
The test item was used as supplied.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Reconstructed Human Epidermis Model (MatTek In Vitro Life Sciences Laboratories, Lot number: 30886).
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C
APPLICATION OF THE TEST ITEM
The assay medium was brought to room temperature before use (37°C, 5% CO2). After pre-incubation of the EpiDerm™ tissues, the medium was aspirated and replaced with 0.9 mL of fresh assay medium.
Dosing was done by adding 50 µL of sterile distilled water (negative control), 50 µL of the test item or 50 µL of 8.0 N Potassium Hydroxide (positive control). Tissues were incubated for 3 or 60 mintes at 37°C.
All incubations were done in duplicate.
REMOVAL OF TEST MATERIAL AND CONTROLS
Rinsing was achieved by filling and emptying each tissue under a constant soft stream of Dulbecco’s Phosphate Buffered Saline (DPBS) (without Ca++ Mg++) for approximately 40 seconds, to gently remove any residual test item. Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper. Each tissue was placed into the prepared holding plate until all tissues were rinsed.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- A pre-test was performed to examine possible interference of the test item with the MTT dye.
- MTT concentration: 1.0 mg/mL MTT solution
- Incubation time: 3 hours
- Spectrophotometer: Labtech LT-4500 microplate reader and LT-com analysis software.
- Wavelength: 570 nm (OD570)
After MTT-loading each tissue was placed in 2 mL of isopropanol for MTT extraction overnight at room temperature. The corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after the 3 and 60-Minute exposure periods, compared to the mean of the negative control tissues (n=2) treated with sterile distilled water. The relative mean viabilities were calculated in the following way:
Relative mean viability (%)= ((mean OD570 of test item)/(mean OD570 of negative control))*100.
DECISION CRITERIA:
In the first step:
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.
Prediction to be considered according to EU CLP Regulation (EC) No 1272/2008 UN GHS:
In the second step:
For test items identified as corrosive in step 1:
- Test item would be classified as H314 (Sub-category 1A) if the viability after 3 minutes exposure is less than 25%.
- Test item would be classified as H314 (Combination of sub-categories 1B-and-1C) if the viability after 3 minutes exposure is higher than or equal to 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 3 minutes and 60 minutes
- Number of replicates:
- Duplicate tissues
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- After 3 minute exposure period
- Value:
- 97.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- 2.3%
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- After 60 minutes exposure period
- Value:
- 97.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- 1.9%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Mean OD570 values and viabilities for the negative control, positive control and test item are given below.
The MTT solution containing the test item did not turn blue/purple. This was taken to indicate the test item did not reduce MTT.
The mean OD570 for the negative control treated tissues was 2.148 for the 3-Minute exposure period and 2.169 for the 60-Minute exposure period. The negative control acceptance criteria were therefore satisfied.
The relative mean tissue viability for the positive control treated tissues was 1.9% relative to the negative control following the 60-Minute exposure period. The positive control acceptance criterion was therefore satisfied.
In the range 20 to 100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The acceptance criterion was therefore satisfied.
Any other information on results incl. tables
Mean OD570 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Tissue | Exposure Period | Mean OD570 of individual tissues | Mean OD570 of duplicate tissues | Standard Deviation | Coefficient of Variation (%) | Relative Mean Viability (%) |
Negative Control | 3 Minutes | 2.174 | 2.148 | 0.037 | 1.7 | 100* |
2.121 | ||||||
60 Minutes | 2.136 | 2.169 | 0.046 | 2.1 | ||
2.201 | ||||||
Positive Control | 3 Minutes | 0.062 | 0.050 | 0.017 | Na | 2.3 |
0.038 | ||||||
60 Minutes | 0.050 | 0.042 | 0.012 | Na | 1.9 | |
0.033 | ||||||
Test item | 3 Minutes | 2.148 | 2.099 | 0.070 | 3.3 | 97.7 |
2.049 | ||||||
60 Minutes | 2.076 | 2.111 | 0.049 | 2.3 | 97.3 | |
2.146 | ||||||
* The mean viability of the negative control tissues is set at 100% |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of an in vitro skin corrosion test, performed according to OECD/EC guidelines and under GLP principles, the substance is considered to be non-corrosive to the skin.
- Executive summary:
An in vitro skin corrosion test was performed according to OECD/EC guidelines and under GLP principles. Duplicate tissues were treated with the negative control, positive control and test item (50µl each) for exposure periods of 3 and 60 minutes. The percentage viability was assessed by MTT reduction. The test item did not interfere with MTT. The mean viabilities were 100%, 2.3% and 97.7% for the vehicle control, the positive control and for the test item, respectively, after 3 minutes exposure. After 60 minutes exposure the viabilities were 100%, 1.9% and 97.3% for the vehicle control, the positive control and for the test item, respectively. The criteria required for acceptance of results in the test were satisfied.
This data indicates that the test item does not have skin corrosive properties.
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.
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