Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 500-288-2 | CAS number: 103213-20-3
- 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:
- 09 - 14 Apr 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- (2013)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- (2009)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
Test material
- Reference substance name:
- Fatty acids, C18-unsatd, dimers, hydrogenated, diisopropyl esters
- EC Number:
- 500-288-2
- EC Name:
- Fatty acids, C18-unsatd, dimers, hydrogenated, diisopropyl esters
- Cas Number:
- 103213-20-3
- Molecular formula:
- Not applicable as UVCB
- IUPAC Name:
- Fatty acids, C18-unsatd, dimers, hydrogenated, diisopropyl esters
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: pale yellow liquid
- Expiration date of the lot/batch: 14 Feb 2017
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: human-derived epidermal keratinocytes (EpiSkin)
- Details on test animals or test system and environmental conditions:
- TEST METHOD
Reconstructed Human Epidermis tissues are provided as kits (SkinEthic). The EpiSkin model is a three-dimensional reconstructed human epidermis model consisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. A highly differentiated and stratified epidermis model is obtained after a 13-Day culture period comprising of the main basal, supra basal, spinous and granular layers and a functional stratum corneum. The test item is applied directly to the culture surface, at the air interface, so that undiluted and/or end use dilutions can be tested directly. Cytotoxicity was determined by the reduction of MTT to formazan by viable cells in the test item treated tissues relative to the negative control.
ADAPTATION TO CELL CULTURE CONDITIONS
On arrival, the human-derived epidermal keratinocyte tissues were transferred into pre-labeled 12-well plates (one for each culture condition) containing 2 mL of pre-warmed maintenance medium. The tissues were incubated overnight at 37 °C and 5% CO2 in air.
INCUBATION CONDITIONS (INCUBATOR)
Temperature (°C): 37
CO2 gas concentration (%): 5
Test system
- Type of coverage:
- other: in vitro system
- Preparation of test site:
- other: intact reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent control tissues treated with DPBS served as negative controls, positive controls were exposed to 5% SDS
- Amount / concentration applied:
- TEST MATERIAL:
Amount(s) applied (volume or weight with unit): 10 μL
NEGATIVE CONTROL SUBSTANCE:
Amount(s) applied (volume or weight with unit): 10 μL DPBS
POSITIVE CONTROL SUBSTANCE:
Positive control substance: 10 μL SDS, 5% (w/v) - Duration of treatment / exposure:
- 15 min
- Observation period:
- Post-treatment incubation period: 42 h
- Number of animals:
- Not applicable. The test was performed in triplicates for each treatment and control group.
- Details on study design:
- TEST SITE
- Area of exposure: 0.38 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Triplicate tissues were treated with the test item and the concurrent positive and negative controls for an exposure period of 15 min. At the end of the exposure period, each tissue was removed from the well and rinsed with DPBS containing calcium and magnesium. The rinsed tissues were transferred to other wells of the same 12-well plate containing 2 mL of maintenance medium in each well. The rinsed tissues were incubated at 37 °C and 5% CO2 in air for 42 hours.
- Time after start of exposure: 15 min
CELL VIABILITY MEASUREMENTS:
For determining alterations in cell viability, MTT reduction assays were performed immediately after the 42 hour incubation period. Therefore, tissues were transferred to new wells of the same 12-well plate containing 2 mL of a 0.3 mg/mL MTT solution, freshly prepared in assay medium. The tissues were incubated for 3 h at 37 °C and 5% CO2 in air. At the end of the 3 hour incubation period each tissue was placed onto absorbent paper to dry. The epidermis was carefully separated from the collagen matrix and both parts (epidermis and collagen) placed into labeled 1.5 mL tubes containing 500 µL of acidified isopropanol. The tubes were refrigerated at 1 to 10 °C until Day 6 of the experiment, allowing the extraction of formazan crystals out of the MTT-loaded tissues. For each tissue, duplicate 200 µL samples were transferred to the appropriate wells of a 96-well plate. The optical density was measured at 562 nm wave length in a microplate reader.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability (%)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of negative controls (DPBS). Time point: 15 min . Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 15.3
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of positive controls (SDS). Time point: 15 min . Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 108.1
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of the test item. Time point: 15 min . Reversibility: other: not applicable. (migrated information)
In vivo
- Irritant / corrosive response data:
- The relative mean viability of the test item treated reconstructed human-derived keratinocyte tissues after a 15 min exposure period was 108.1% compared to the negative control. Therefore, the test item is considered to be a non-irritant.
Any other information on results incl. tables
Table 1: Mean OD562 Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
OD562 of tissues |
Mean OD562 of triplicate tissues |
± SD of OD562 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative Control Item |
0.767 |
0.767 |
0.05 |
100 |
100* |
6.2 |
0.719 |
93.7 |
|||||
0.814 |
106.1 |
|||||
Positive Control Item |
0.145 |
0.118 |
0.06 |
18.9 |
15.3 |
7.7 |
0.158 |
20.6 |
|||||
0.050 |
6.5 |
|||||
Test Item |
0.813 |
0.829 |
0.01 |
106.0 |
108.1 |
1.9 |
0.842 |
109.8 |
|||||
0.833 |
108.6 |
SD: Standard deviation
*: The mean viability of the negative control tissues is set at 100%.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.