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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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Remarks:
- Skin Irritation Test
- Adequacy of study:
- key study
- Study period:
- 2022-02-10 until 2022-03-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: • MatTek Corporation Protocol: In vitro EpiDermTM Skin Irritation Test (EPI-200-SIT) For use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm (EPI-200-SIT); Version 12/04/2020. • MatTek Corporation Protocol: EpiOcularTM Eye Irritation
- Version / remarks:
- Note:
The Pre-Test (Assessment of Colored or Staining Materials and Assessment of Direct Test Article Reduction by MTT) was performed according to the MatTek Protocol “EpiOcularTM Eye Irritation Test.
Reason:
The OECD TG 439 requires the evaluation of colored or staining materials spectrophotometrically but does not state the evaluation criteria. These criteria are missing in the MatTek protocol “In vitro EpiDermTM Skin Irritation Test”, too. But the identical scientific hypothesis is to clarify in the Eye Irritation Test and there the requirements are described. - Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UN GHS
- Version / remarks:
- published 2003, last (8th revision) 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Reconstructed Human Epidermis Test Methods (14 June 2021), and as described in detail in the Protocol for:
In vitro EpiDermTM Skin Irritation Test (EPI-200-SIT) for use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm (EPI-200). - Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 06 July 2012
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Date of GLP Certificate: 2019-10-23
Test material
- Reference substance name:
- Paraffin waxes (Fischer-Tropsch), isomerization
- Cas Number:
- 2658498-20-3
- Molecular formula:
- C25H52 - C150H302
- IUPAC Name:
- Paraffin waxes (Fischer-Tropsch), isomerization
- Details on test material:
- - Purity: 100%
- Molecular weight: Not applicable (UVCB)
- Physical state / Appearance: Solid / white
- Expiry Date / Retest Date: Not indicated
- Storage Conditions: Room temperature
- Stability in Solvent: Not indicated
Constituent 1
- Specific details on test material used for the study:
- Appearance: White, solid (waxy)
Storage Conditions: At room temperature
Stability in Solvent: Not indicated
In vitro test system
- Test system:
- human skin model
- Source species:
- other: Standard Assay Kit and MTT-100 kit were purchased from MatTek Corporation (82105 Bratislava, Slovakia, Lot No.: 36129).
- Justification for test system used:
- Dermal irritation is generally defined as "the production of reversible inflammatory changes in the skin". The potential for chemical induced skin irritation is an important consideration in establishing procedures for the safe handling, packing and transport of chemicals. It is usually determined in the in vivo Draize rabbit skin irritation test as described in OECD guideline 404. Because systemic reactions play a minor role in modulating local skin toxicity potential of chemicals, skin irritation potential may be predicted by in vitro systems, provided they are sufficiently complex to mimic human skin barrier and cell reactivity. In an international prevalidation study performed by ECVAM, the in vitro skin irritation test using the human skin model EpiDerm™ and EpiSkin™ and measurement of cell viability by dehydrogenase conversion of MTT into a blue formazan salt have turned out as a sufficiently promising predictor for skin irritancy potential.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- In vitro Skin Irritation Test (OECD 439)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):25 +/- 2 mg (39.7 mg/cm2 according to guideline)
NEGATIVE CONTROL
- Concentration (if solution): 30 µL DPBS
POSITIVE CONTROL
- Concentration (if solution): 5% SDS solution in deionised water (MatTek) - Duration of treatment / exposure:
- 60 minutes
- Number of replicates:
- Three tissues
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test Item
- Value:
- 100.08
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- according to UN GHS and EU CLP regulations
Any other information on results incl. tables
Main Experiment: Results after treatment with test item and controls
Treatment Group | Tissue No. | Well 1 OD 570 nm | Well 2 OD 570 nm | Well 3 OD 570 nm | Mean OD of | Mean OD of 3 Wells blank corrected | Mean OD of 3 tissues | Rel. Viability [%] Tissue | Standard Deviation | Mean Rel. Viability [%] |
Treatment Group | Tissue No. | 0.037 |
|
|
|
|
|
|
|
|
Blank |
| 1.580 | 0.037 | 0.037 | 0.037 |
|
|
|
|
|
Negative Control | 1 | 1.625 | 1.537 | 1.561 | 1.559 | 1.522 |
| 97.658 |
|
|
2 | 1.658 | 1.596 | 1.590 | 1.604 | 1.567 | 1.559 | 100.530 | 2.1 | 100.0 | |
3 | 0.125 | 1.606 | 1.607 | 1.624 | 1.587 |
| 101.813 |
|
| |
Positive Control | 1 | 0.100 | 0.110 | 0.109 | 0.115 | 0.078 |
| 5.004 |
|
|
2 | 0.106 | 0.094 | 0.092 | 0.095 | 0.058 | 0.066 | 3.742 | 0.7 | 4.25 | |
3 | 1.575 | 0.097 | 0.094 | 0.099 | 0.062 |
| 3.997 |
|
| |
Test Item | 1 | 1.626 | 1.567 | 1.565 | 1.569 | 1.532 |
| 98.297 |
|
|
2 | 1.607 | 1.609 | 1.611 | 1.615 | 1.579 | 1.560 | 101.272 | 1.6 | 100.08 | |
3 |
|
|
| 1.606 | 1.569 |
| 100.669 |
|
|
OD: optical density
Applicant's summary and conclusion
- Interpretation of results:
- other: EU-GHS criteria not met
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the registration substance is non-irritant to skin according to UN GHS and EU CLP regulation.
- Executive summary:
This in vitro study was performed to assess the skin irritation potential of the registration substance 'Paraffin waxes (Fischer-Tropsch), isomerization' by means of the Human Skin Model Test.
The test item did not prove to be a MTT reducer in the MTT interference pre-experiment. Also, its intrinsic color was not intensive and the OD of the test item in deionised water or isopropanol at 570 nm after blank correction was < 0.08. Therefore, additional tests with freeze-killed tissues or viable tissues (without MTT addition) did not have to be performed.
Each three tissues of the human skin model EpiDerm™ were treated with the test item, the negative control (DPBS) or the positive control (5% SDS) for 60 minutes.
After treatment with the negative control the absorbance values were well within the required range of the acceptability criterion of mean OD 0.8 and ≤ 2.8 for the 60 minutes treatment interval, thus assuring the quality of the tissues.
Treatment with the positive control induced a decrease in the viability compared with the negative control to 4.25%, thus ensuring the validity of the test system.
The standard deviations between the three tissue percentage viability values of each group (test item, positive and negative controls) in the main test were below 18 (threshold according to OECD 439: ≤ 18), thus ensuring the validity of the study.
After treatment with the test item the mean viability value was 100.08% compared to the relative absorbance value of the negative control. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
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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