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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:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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
- Details on test material:
- Test item : FAT 40875/A TE
Physical appearance : Dark red powder
Purity as per CoA : 86.4% all organic components
Batch No. : BOP 05-17 (BS-ROE 1550 NIM 25+26+27)
Manufactured date : 20 December 2017
Expiry date : 11 December 2022
pH : 4.3 (aq. soln. 2 %w/w at room-temperature)
Recommended storage condition: Refrigeration (+2 to +8 °C) and protection from light
Constituent 1
- Specific details on test material used for the study:
- Test Item: 40875/A TE
Physical Appearance: Dark red powder
Purity as per Certificate of Analysis (Content): 86.4% all organic components
Batch No.: BOP 05-17 (BS-ROE 1550 NIM 25+26+27)
Manufactured Date: 20 December 2017
Expiry Date: 11 December, 2022
Recommended Storage Condition : Refrigeration (+2 to +8 °C), Protect from light
pH: 4.3 (aq. soln.(2% (w/w) at room-temperature)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: normal human keratinocytes
- 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:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkin
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 20 - 28 °C
- Temperature of post-treatment incubation: 37 ± 1 °C
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 42h
- Spectrophotometer: TECAN Infinite® M200 Microplate Reader
- Wavelength: 570nm
NUMBER OF REPLICATE TISSUES: Triplicate
PREDICTION MODEL / DECISION CRITERIA:
- The test substance is considered to be corrosive to skin if [complete, e.g. 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 [complete, e.g. 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%.] - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 mg/tissue of test substance was applied topically to the EpiSkin three dimensional RhE model.
Negative control : 10 microliter of Phosphated Buffered Saline (PBS).
Positive control : 10 microliter of 5% Sodium Dodecyl Sulfate (SDS). - Duration of treatment / exposure:
- Incubation for 15 minutes at room temperature (20 - 28 °C)
- Duration of post-treatment incubation (if applicable):
- Tissues were incubated with MTT solution for 4 hours and then extracted with acidified isopropanol to quantify spectrophotometrically at wavelength of 570 nm.
- Number of replicates:
- Three
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- True tissue viability
- Value:
- 131.23
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: Yes
- Colour interference with MTT: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: 0.753% mean cell viability.
- Acceptance criteria met for positive control: 6.89% mean cell viability.
- Acceptance criteria met for variability between replicate measurements: Yes, the standard deviation was within the range.
Any other information on results incl. tables
Individual tissue viability of epidermis units (relative)
% Individual Viability | |||||
R1 | R2 | R3 | Mean | SD | |
Positive control | 6.63 | 7.40 | 6.64 | 6.89 | 0.44 |
Test item | 88.07 | 88.30 | 91.89 | 89.42 | 2.14 |
% NSC living tissue | 4.13 | 4.30 | - | 4.22 | 0.12 |
% NSMTT killed tissue | 4.86 | 6.61 | - | 5.74 | 0.24 |
% NSC killed tissue color | 51.21 | 52.32 | - | 51.77 | 0.78 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean relative tissue viability for the test item, FAT 40875/A TE was 131.23 % and hence, the test item is predicted to be non-irritant.
- Executive summary:
The test item, FAT 40875/A TE was tested for its skin irritation potential using a three-dimensional Reconstructed Human Epidermis model, EpiSkin, through topical application. This test was conducted in accordance with OECD test guideline 439 in a GLP certified laboratory.
10 mg/tissue of test item, 10µL of negative control (PBS) & 10µL of positive control (5% of SDS) respectively was exposed for 15 minutes.
In the preliminary tests, FAT 40875 was identified as producing direct MTT reduction and color interference and thus adapted controls evaluation was performed.
After approximately 42-hour post incubation period, irritation potential was evaluated by assessing the cytotoxic (irritancy) effect. The cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured on formazan production from MTT and the end of 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 mins of treatment with the test item is compared with negative control tissues.
The absolute mean Optical density (OD) at 570nm of negative control, positive control and test item was 0.7530, 0.0519 and 0.6733 respectively. The positive control had a mean cell viability of 6.89% after 15 mins exposure, indicating the test system functioned properly.
The true tissue viability of the test item was found to be 131.23%.
The study indicated that the test item FAT 40875/A TE is predicted to be non-irritating in this In-vitro skin irritation test using Reconstructed Human Epidermis under the condition 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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