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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 268-159-0 | CAS number: 68015-93-0
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 October 2015 - 19 November 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octadec-2-enylsuccinic acid
- EC Number:
- 268-159-0
- EC Name:
- Octadec-2-enylsuccinic acid
- Cas Number:
- 68015-93-0
- Molecular formula:
- C22H40O4
- IUPAC Name:
- 2-octadec-2-en-1-ylsuccinic acid
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Batch No: E00974-38D&F
Retest Date: 22 June 2018
Purity: 100%
Physical Description: Pale amber waxy solid
Storage Conditions: Ambient / dark
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: The human keratinocytes came from healthy consenting donors
- Justification for test system used:
- The EpiSkin® in vitro corrosion test uses EpiSkin® tissues supplied by SkinEthic. The Episkin® reconstructed human epidermis model has been accepted as a valid model for skin corrosion assessment by the OECD.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The human keratinocytes came from healthy consenting donors. HIV 1 & 2, HEP B and HEP C tests were carried out on the donors as well as verification of the bacteriological and fungal sterility of the cells and absence of mycoplasma. After a period of culture (13 days) a
well differentiated epidermis consisting of a basal layer, several spinous and granular layers and a thick stratum corneum were detectable. The surface area was 0.38 cm2.
The reproducibility of each batch was checked by histological analysis taking into account the general organisation, structure, and the reproducibility of the response of each EpiSkin batch was tested against a reference irritant: SDS. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 20 mg ± 2 mg
- Duration of treatment / exposure:
- 3 min, 1 h +/- 5 min, or 4 h +/- 10 min
- Number of replicates:
- 3 replicates per exposure time
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 mins
- Value:
- ca. 75.52
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- ca. 118.44
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 4 hours
- Value:
- ca. 102.55
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The Substance did not reduce MTT.
The Substance did not become coloured upon mixing with ultrapure water.
Any other information on results incl. tables
See attached background documents
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Substance was demonstrated to be non-corrosive when tested in the EpiSkin in vitrocorrosion assay.
- Executive summary:
In this study the corrosion potential of Substance was evaluated using the EpiSkin®in vitrocorrosion test.
Prior to the conduct of the corrosion assay, two preliminary tests were conducted to assess the intrinsic ability of the test item to reduce methylthiazoldiphenyl-tetrazolium bromide (MTT) to formazan, a measure of cell viability in the assay, and to assess the potential of the test item to cause colour interference. Substance did not reduce MTT to formazan or have the potential to cause colour interference, therefore, would not compromise the assay.
To assess dermal corrosion Substance was applied (20 mg ± 2 mg) to the exposed surface of EpiSkin®tissues for exposure periods of 4 h, 1 h and 3 min (3 tissues per exposure time). Due to the waxy nature of the test item it was heated toca 75°C then pipetted onto small filter papers, flattened onto the paper with a spatula and weighed. Filter papers were carefully placed on the exposed surface of the EpiSkin®tissue. The EpiSkin®surface area was 0.38 cm2, therefore the application rate wasca 52.6 mg/cm2. At the end of the exposure period, the filter papers were carefully removed and the surface of the Episkin®washed using Dulbecco’s phosphate-buffered saline (DPBS). The Episkin®tissues were transferred to MTT solution (0.3 mg/mL in assay medium) and incubatedin a humidified incubator set to maintain atemperature of 37°C and a CO2level of 5% for 3 h. Biopsies of the Episkin®membranes were removed, added to acidified isopropanol and left overnight, protected from light in order to extract formazan. The formazan production (cell viability) was assessed by measuring the optical density of the extracts at a wavelength of 570 nm.
Three replicates of each control (physiological saline, negative control, and acetic acid, positive control) were tested in parallel to test item treated tissues. Positive control was tested with the 4 h exposure group only, negative control was tested for all 3 exposure periods. The viability of each individual EpiSkinÒtissue was calculated as a percentage of the appropriate mean negative control viability (defined as 100%).
The mean A570of all negative control treated tissues was within 0.6-1.5 and the mean viability of positive control treated tissues was <20% therefore satisfying the assay acceptance criteria. Mean tissue viability (± SD) for test item treated tissues was 102.55 ± 16.53% (4h exposure), 118.44 ± 6.43% (1h exposure), and 75.52 ± 7.31% (3 min exposure).
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.