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EC number: 271-985-4 | CAS number: 68648-28-2
- 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:
- From April 24, 2017 to April 28, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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)
- Version / remarks:
- Adopted July 23, 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Adopted July 28, 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Linseed oil, ester with pentaerythritol
- EC Number:
- 271-985-4
- EC Name:
- Linseed oil, ester with pentaerythritol
- Cas Number:
- 68648-28-2
- Molecular formula:
- UVCB
- IUPAC Name:
- 2,3-dihydroxypropyl (7E,10E,13E)-hexadeca-7,10,13-trienoate; bis(3-[(7E,10E,13E)-hexadeca-7,10,13-trienoyloxy]-2-hydroxypropyl (9E)-octadec-9-enoate); 3-hydroxy-2-(hydroxymethyl)-2-[(octadec-9-enoyloxy)methyl]propyl (9E,12E,15E)-octadeca-9,12,15-trienoate; 3-hydroxy-2-{[(9E)-octadec-9-enoyloxy]methyl}-2-{[(9E,12E)-octadeca-9,12-dienoyloxy]methyl}propyl (9E,12E,15E)-octadeca-9,12,15-trienoate
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test system is a commercially available EpiDermTM-Kit (EPI-212-SIT, batch no: 25809, 2017), procured by MatTek. The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- - One plate (3 tissues) was used as negative control in which each tissue was treated with 30 μL DPBS buffer.
- One plate was used as positive control in which each tissue was treated with 30 μL 5% SDS-solution.
- One plate was used for treatment with the test substance in which 30 μL test substance were applied.
A nylon meshes were added to all plates in order to ensure sufficient contact with the tissue surface. - Duration of treatment / exposure:
- Tissues were dosed in 1-minute-intervals. After dosing the last tissue, all plates were transferred into the incubator for 35 minutes at 37 ± 1°C and 5.0 ± 0.5% CO2. 1 h after the first application, the inserts were removed from the plates using sterile forceps and rinsed immediately in 1-minute-intervals. After rinsing, each tissue was blotted with sterile cellulose tissue and then transferred into a new 6-well-plate with fresh assay medium (0.9 mL). Then, the tissues were set in the incubator for 23 h and 30 minutes at 37 ± 1°C and 5.0 ± 0.5% CO2.
- Duration of post-treatment incubation (if applicable):
- Post-incubation, the tissues were removed from the incubator and shaken for 5 minutes (120 rpm). 0.9 mL assay medium were filled in the lower row of the 6-well-plate. Then the inserts were transferred into the lower row of the 6-well-plate and set into the incubator for 19 h for post-incubation at 37 ± 1°C and 5.0 ± 0.5% CO2.
- Number of replicates:
- From each well, two replicates with 200 μL solution (each) were pipetted into a 96-well-plate which was read in a plate spectrophotometer at 570 nm.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue viability is calculated as % photometric absorbance compared with the mean of the negative controls
- Value:
- ca. 96.9 - ca. 103.5
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The relative absorbance value was reduced to 99.9 % after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item is considered as non-irritant to skin. Values for negative control and for positive control were within the range of historical data of the test facility. Therefore, the experiment is considered valid.
Any other information on results incl. tables
Comparison of Tissue Viability
For the test item and the positive control, the following percentage values of tissue viability (in the form of formazan production) were calculated in comparison to the negative control:
Designation |
linseed oil, ester with pentaerythritol |
Positive Control |
% Tissue viability (tissue 1) |
99.5% |
4.1% |
% Tissue viability (tissue 2) |
103.5% |
3.6% |
% Tissue viability (tissue 3) |
96.9% |
3.9% |
% Tissue viability (mean) |
99.9% |
3.8% |
± SD of mean tissue viability (%) |
3.3% |
0.2% |
The relative absorbance value was reduced to 99.9 % after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test substance is considered as non-irritant to skin.
Validity and Acceptability
Validity criteria and results are stated in the following table:
Criterion |
Demanded |
Found |
OD of negative control |
≥ 0.8 and ≤ 2.8 |
1.7 |
% tissue viability of positive control SDS |
≤ 20% of negative control |
3.8% |
SD of mean viability of the tissue replicates (%) |
≤ 18% |
1.0% (negative control) 0.2% (positive control) 3.3% (test item) |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was considered as non-irritating to skin in the RhE test method.
- Executive summary:
A study was conducted to determine skin irritation potential of the test substance in the Reconstructed Human Epidermis (RhE) according to EU Method B.46 and OECD Guideline 439, in compliance with GLP. Three tissues of the human skin model EpiDermTM were treated for 60 minutes. The test substance was applied directly to each tissue and spread to match the tissue size (0.63 cm2). DPBS-buffer was used as negative control, 5% SDS solution was used as positive control. After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.7. The positive control showed clear irritating effects. Relative absorbance was reduced to 3.8% (required: ≤20%). Variation within the tissue replicates was acceptable (required: ≤18%). After the treatment with the test item, the relative absorbance value was reduced to 99.9%. This value is above the threshold for skin irritation potential (50%). Therefore, the test substance was considered as non-irritating to skin in the RhE test method (Andres, 2017).
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