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Diss Factsheets
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EC number: 500-320-5 | CAS number: 130353-58-1
- 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 431 (In vitro skin corrosion: Human skin model test) adopted 2004
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 921-836-0
- EC Number:
- 921-836-0
- IUPAC Name:
- 921-836-0
- Details on test material:
- - Name of test material (as cited in study report): [trade name]
- Composition: mixed ester of fatty acids, C 16 and C 16-18 unsaturated with adipic acid and pentaerithrytol
- Physical state/appearance: yellow liquid
- Analytical purity: no data
- Batch No.: 103991
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- SkinEthic
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- other: PBS
- Details on test system:
- TEST SYSTEM
The test substance was applied topically on SkinEthic RHE tissues, a 3D system of reconstructed epidermis of normal human keratinocytes with a functional stratum corneum. Cells are grown on inert polycarbonate filter on chemically defined medium, airlifted for 17 days. The model exhibits normal barrier functions (presence of a differentiated stratum corneum).
- Supplier of SkinEthic RHE tissue, maintenance medium (SMM) and growth medium (SGM): SkinEthic
PRE-TEST
The test product was put in contact with MTT (thiazolyl blue tetrazolium) solution to detect non-specific reduction of MTT. 40 µL of sample were incubated for 3 hours at 37 °C with 300 µL of MTT ready to use, water was used as negative control. At the end of this period a visual observation was performed and interpreted according to the following criteria:
Yellow: no interaction; light blue: slight interaction; dark blue: strong interaction
If the MTT solution becomes blue or purple the sample interact with MTT and is necessary to evaluate the part of optical density due to a non-specific reduction of the MTT.
MAIN TEST
The test product, the negative and positive control were applied in duplicate on the tissues for 3 minutes and 1 hour at room temperature.
At the end of the exposure time the product and the controls were removed from the tissues and the tissues rinsed for 5 times with PBS.
After the post treatment the tissues were treated for 3 hours at 37 °C, 5% Co2 with MTT ready to use and then put in contact with 1.5 mL of isopropanol for 2 hours at room temperature with gentle agitation for formazan extraction. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 40 ± 0.5 µL
- Duration of treatment / exposure:
- 3 min and 1 h
- Duration of post-treatment incubation (if applicable):
- 3 h
- Number of replicates:
- Triplicates each in 2 independent experiments
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- 88.98
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- 100
- Positive controls validity:
- valid
- Remarks:
- 0.59
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min exposure
- Value:
- 88.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- 100
- Positive controls validity:
- valid
- Remarks:
- 0.42
Any other information on results incl. tables
Table 1: Individual values: optic density (OD) at 570 nm; 3 minutes treatment
3 min |
1 |
2 |
3 |
4 |
5 |
6 |
Mean |
%Viability |
Blank |
0.086 |
0.087 |
0.091 |
0.089 |
0.088 |
0.088 |
0.088 |
- |
Negative control |
1.255 |
1.269 |
1.266 |
1.266 |
1.266 |
1.271 |
1.266 |
100% |
Positive control |
0.095 |
0.093 |
0.094 |
0.096 |
0.095 |
0.096 |
0.095 |
0.59% |
Sample |
1.121 |
1.141 |
1.139 |
1.147 |
1.133 |
1.145 |
1.138 |
88.98% |
Table 2: Individual values: optic density (OD) at 570 nm; 1 hour treatment
1 h |
1 |
2 |
3 |
4 |
5 |
6 |
Mean |
%Viability |
Blank |
0.087 |
0.087 |
0.088 |
0.092 |
0.087 |
0.086 |
0.088 |
- |
Negative control |
1.297 |
1.275 |
1.281 |
1.280 |
1.293 |
1.279 |
1.284 |
100% |
Positive control |
0.093 |
0.091 |
0.093 |
0.094 |
0.093 |
0.092 |
0.093 |
0.42% |
Sample |
1.152 |
1.155 |
1.151 |
1.144 |
1.155 |
1.142 |
1.150 |
88.5% |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the Human skin model test the test substance possessed no corrosive properties towards the skin.
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