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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
- Adequacy of study:
- key study
- Study period:
- Study initiation date - 11 January 2021; Experiment start date - 18 January 2021; Experiment completion date - 22 January 2021; Study completion date - 05 March 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Test Item: FAT 75637/B TE
Physical Appearance: Light yellow powder
Purity: 99.4 % all organic constituents; 95.0 % main constituent
Batch No: AT-0063765400
Manufactured Date: 21st April 2020
Expiry Date: May 27th, 2025
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Justification for test system used:
- The assessment of skin irritation has typically involved the use of laboratory animals (OECD TG 404). In relation to animal welfare concerns, TG 404 recommends the use of a tiered testing strategy for the determination of skin corrosion and irritation which includes the use of validated in vitro or ex vivo test methods avoiding pain and suffering of animals.
One of the validated in vitro test methods adopted by the OECD TG 439 makes use of reconstructed human epidermis (RhE) which closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis. - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiSkin kit
EpiSkin is an in vitro reconstructed human epidermis (RHE) from normal human keratinocytes cultured on a collagen matrix at the air liquid interface. This is a three-dimensional human skin model comprising a reconstructed epidermis with a functional stratum corneum. Differentiated and stratified epidermis model comprises the main basal, supra basal, spinous and granular layers and a functional stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 mg
- Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours ± 1
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 15 minutes exposure
- Value:
- 72.03
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Preliminary Tests for Coloring and Direct MTT Reduction Potential of the Test Item: In the coloring potential test, the resultant solution was not colored, hence, it was concluded that the test item does not have the intrinsic ability to become colored when it interacts with water. In the direct MTT reduction potential test, the color of MTT solution did not turn to either blue or purple, hence, it was concluded that the test item did not interact with MTT. Similarly, the water control tested did not show any coloring potential nor did it reduce the MTT.
Skin Irritation Test
The results show the mean tissue viability obtained after 15 minutes treatment with the test item compared to the negative control tissues. Skin irritation is expressed as the ability of the test item to reduce the cell viability after exposure to the test items. The relative mean tissue viability obtained after 15 minutes treatment with the test item compared to the negative control tissues was 72.03 %. The positive control had a mean cell viability of 4.74 % after 15 minutes exposure. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range.
Any other information on results incl. tables
Individual Tissue Viability of Epidermis Units (Relative)
| % Individual Viability | ||||
R1 | R2 | R3 | Mean | SD | |
Positive control | 4.58 | 4.69 | 4.96 | 4.74 | 0.20 |
Test Item | 66.63 | 74.00 | 75.46 | 72.03 | 4.73 |
SD: Standard Deviation Negative control mean: 0.9283
R1, R2 & R3: triplicate exposures
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean relative tissue viability for the test item was 72.03 %. Hence, the test item is predicted to be non-irritant under the experimental conditions described in this report.
- Executive summary:
The test item, FAT 75637/B was tested for its possible skin irritation potential using a three-dimensional Reconstructed Human Epidermis model, EpiSkin, through topical application for 15 minutes. This study was conducted according to OECD test guideline 439 in a GLP-certified laboratory. The test item is a solid and was applied directly to the top of the skin tissues at 10 mg/tissue and exposed for 15 minutes. Ten microliters (10 µL) of PBS and 10 µL of 5 % aqueous SDS were used as the negative and positive controls, respectively. After 41-hour post-incubation period, irritation potentials of FAT 75637/B TE were evaluated by assessing the cytotoxic (irritancy) effect. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Skin irritation is expressed as the ability of the test item to reduce the cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 minutes treatment with the test item was compared to the negative control tissues. The absolute mean OD570(optical density at 570 nm) of the negative control tissues was 0.9838. The positive control had a mean cell viability of 4.74 % after 15 minutes exposure, indicating that the test system functioned properly. The study indicated that the test item FAT 75637/B is predicted to be non- irritant in this in vitro skin irritation test as the percent viability is 72.03 % using reconstructed human epidermis under the conditions of testing employed.
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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