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Diss Factsheets
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EC number: 292-832-8 | CAS number: 91001-61-5
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
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
Test animals
- Species:
- other: not applicable (in vitro test)
- Strain:
- other: not applicable (in vitro test)
- Details on test animals or test system and environmental conditions:
- 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
Test system
- Type of coverage:
- other: not applicable (in vitro test)
- Preparation of test site:
- other: not applicable (in vitro test)
- Vehicle:
- other: PBS
- Controls:
- other: not applicable (in vitro test); negative (water) and positive (glacial acetic acid) control were included
- Amount / concentration applied:
- 40 ± 0.5 µL
- Duration of treatment / exposure:
- 3 minutes and 1 hours at 37 °C
- Observation period:
- not applicable (in vitro test)
- Number of animals:
- not applicable (in vitro test)
- Details on study design:
- 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.
Results and discussion
In vivo
- Irritant / corrosive response data:
- - Cell viability after 3 min treatment: 88.98%
- Cell viability after 1 h treatment: 88.5%
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: not corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- There is regulatory acceptance in the EU that a substance can be considered corrosive based on a positive result in one of the available in vitro test methods, e.g. the human skin model (HSM) test (OECD 431). Negative in vitro corrosivity responses are not conclusive with respect to non-classification or classification as irritant (Category 2/R37) and shall therefore be subject to further evaluation.
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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