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Diss Factsheets
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EC number: 952-026-5 | 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 February 2021 - 20 February 2021
- 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:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Synthetic wollastonite
- EC Number:
- 952-026-5
- Molecular formula:
- CaSiO3
- IUPAC Name:
- Synthetic wollastonite
- Test material form:
- solid: bulk
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Imerys
- Lot/batch number of test material: 2011 20
- Purity, including information on contaminants, isomers, etc.: 100%
- Molecular weight: 116.16 g/mol
- Expiry date: 27 November 2030
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was used as supplied.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Supplier: MatTek In Vitro Life Sciences Laboratories
- Model used: EPIDERM™ Reconstructed Human Epidermis
- Tissue batch number(s): 34123
- Delivery date: 17 February 2021
- Date of initiation of testing: 17 February 2021
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 Deg C
- Temperature of post-treatment incubation: 37 Deg C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Rinsing was achieved by filling and emptying each tissue insert approximately 15 times using a constant soft stream of DPBS to gently remove any residual test item. The rinsed tissues were then submerged 3 times in 150 ml of DPBS without Ca++ and Mg++.
- Observable damage in the tissue due to washing: No
- Modifications to validated SOP: No
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE: yellow tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide)
- MTT concentration: 1.0 mg/mL
- Incubation time: 1 hour
- Spectrophotometer: Labtech LT-4500 microplate reader
The upper limit of accuracy for measured absorbance of MTT Formazan at 570 nm (OD570),
filter band pass 10 nm, was determined to be at an optical density of 2.6. (Warren, N; 2017).
- Linear OD range of spectrophotometer: OD570
NUMBER OF REPLICATE TISSUES: Triplicate
PREDICTION MODEL / DECISION CRITERIA
Data Evaluation
Quantitative MTT Assessment (Percentage Tissue Viability)
For the test item the relative mean tissue viabilities obtained after the 60-Minute exposure period followed by the 42-Hour post-exposure incubation period were compared to the mean of the negative control treated tissues (n=3). The relative mean viabilities were calculated in the following way:
Relative mean viability (%) = (mean OD570 of test item/mean OD570 of negative control) x 100
Classification of irritation potential is based upon relative mean tissue viability following the
60-Minute exposure period followed by the 42-Hour post-exposure incubation period
according to the following:
Relative mean tissue viability is ≤50% = Corrosive or Irritant - H314 or H315 Category 1 or 2
Relative mean tissue viability is >50% = Non-irritant - Not classified for irritation
If the relative mean tissue viability is ≤50%, differentiation between EU CLP/UN GHS Category 1 and Category 2 will not be possible based on the results of this study in isolation.
EU CLP/UN GHS:
Hazard Category 1 - Code H314; Statement “Causes severe skin burns and eye damage”
Hazard Category 2 - Code H315; Statement “Causes Skin Irritation”
Acceptance Criteria
The results of the assay are considered acceptable if the following assay acceptance criteria are achieved:
Positive Control:
The assay establishes the acceptance criterion for an acceptable test if the relative mean tissue viability for the positive control treated tissues is ≤20% relative to the negative control treated tissues.
Negative Control:
The assay establishes the acceptance criterion for an acceptable test if the mean OD570 for the negative control treated tissues is equal or greater than 0.8 and ≤2.8.
Standard Deviation:
The assay establishes the acceptance criterion for an acceptable test if the standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues is ≤18% for each testing or control group. - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg
- Concentration (if solution): The test item was used as supplied.
NEGATIVE CONTROL: Dulbecco’s Phosphate Buffered Saline (DPBS) with Ca++ and Mg++
- Amount(s) applied (volume or weight): 30 μL
- Concentration (if solution): Used as supplied.
POSITIVE CONTROL: Sodium dodecyl sulphate
- Amount(s) applied (volume or weight): 30 μL
- Concentration (if solution): Prepared as a 5% w/v aqueous solution.
MTT SOLUTION
- Amount(s) applied (volume or weight): 1 mL
- Concentration (if solution): 1.0 mg/mL MTT solution. - Duration of treatment / exposure:
- 60 +/- 1 minutes
- Duration of post-treatment incubation (if applicable):
- 1st period: 24 +/- 2 hours, 2nd period 18 +/- 2 hours
- Number of replicates:
- Triplicate
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60-Minute exposure period and 42-Hour post-exposure incubation period
- Value:
- 100.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- It was considered unnecessary to perform IL-1a analysis on the assay medium, retained from
the wells of the 24 ±2 hour post exposure incubation plate, as the results of the MTT test
were unequivocal.
Any other information on results incl. tables
Direct MTT Reduction
The MTT solution containing the test item did not turn blue or purple which indicated that the test item did not directly reduce MTT.
Assessment of Color Interference with the MTT endpoint
The solutions containing the test item were colorless. It was therefore unnecessary to run color correction tissues.
Acceptance Criteria
The relative mean tissue viability for the positive control treated tissues was 4.0% relative to the negative control treated tissues. The positive control acceptance criteria were therefore satisfied.
The mean OD570 for the negative control treated tissues was 1.813. The negative control acceptance criteria were therefore satisfied.
The standard deviation between the three tissue replicates of each treatment group did not exceed 18%. The acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study and under the experimental conditions reported, the test item was classified as non-irritant.
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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