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EC number: 262-114-9 | CAS number: 60239-68-1
- 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:
- key study
- Study period:
- From April 05, 2017 to April 07, 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:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N-bis(2-hydroxyethyl)undec-10-enamide
- EC Number:
- 262-114-9
- EC Name:
- N,N-bis(2-hydroxyethyl)undec-10-enamide
- Cas Number:
- 60239-68-1
- Molecular formula:
- C15H29NO3
- IUPAC Name:
- N,N-bis(2-hydroxyethyl)undec-10-enamide
- Test material form:
- liquid
- Details on test material:
- The test substance is the reaction product of 10-undecenoicacid methyl ester with diethanolamine (DEA). The methanol formed in the process is removed by distillation. The final product is a clear liquid at 20 °C and 101.3 kPa.
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- artificial three-dimensional model of human skin
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- This test method provides an in vitro procedure that, depending on information requirements, may allow determining the cytotoxic potency and skin irritancy of test substances as a stand-alone replacement test within a testing strategy, in a weight of evidence approach.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Three tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed as relative percentage of viability of the negative control-treated tissues.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test substance was applied as liquid test substance topically undiluted to the model skin surface.
- Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- cells
- Run / experiment:
- MTT test (mean viablility compared to the negative control - %)
- Value:
- 6.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: prediction of irritation
- Other effects / acceptance of results:
- - The mean viability of cells exposed to the test substance was 6.5% of the negative controls and, hence, was below the cut-off percentage cell viability value that distinguishes irritant from non-irritant test substances of ≤50%. The test substance was considered to be cytotoxic and predicted to be irritant to skin in accordance with UN GHS category 1 or 2 (H314 or H315).
- The mean optical density (OD) of 3 negative control tissues was 1.314 and was well within the acceptable range of ≥ 1.0 to ≤ 2.5. The viability of cells treated with the positive reference substance, 5% SDS, was 6.9% of the negative control and fulfilled the acceptance criterion of ≤20%.
- The standard deviation of all triplicates determined was below the limit of acceptance of 18%. Hence, all acceptance criteria were fulfilled.
Any other information on results incl. tables
None.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the study conditions, the test substance was predicted to be a skin irritant.
- Executive summary:
A study was conducted to determine the in vitro skin irritation potential of the test substance, C11-unsatd. DEA, according to OECD Guideline 439 and EU Method B.46 (three-dimensional reconstructed human epidermis model EpiDermTM), in compliance with GLP. The test substance was applied for 60 min in liquid form topically, undiluted, to the model skin surface (3 replicates). This was followed by a 42 h post incubation period. The optical density (OD) was determined by using the MTT reduction assay and expressed as relative percentage of viability of the negative control-treated tissues. The mean viability of cells exposed to the test substance was 6.5% of the negative controls and, hence, was below the cut-off percentage cell viability value that distinguishes irritant from non-irritant test substances of ≤50%. The test substance was considered to be cytotoxic and predicted to be irritant to skin in accordance with UN GHS classification. The mean optical density (OD) of 3 negative control tissues was 1.314 and well within the acceptable range of ≥1.0 to ≤2.5. The viability of cells treated with the positive reference substance, 5% SDS, was 6.9% of the negative control and fulfilled the acceptance criterion of ≤ 20%. The standard deviation of all triplicates determined was below the limit of acceptance of 18%. Hence, all acceptance criteria were fulfilled. Under the study conditions, the test substance was predicted to be a skin irritant (Spruth, 2017).
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