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EC number: 686-853-5 | CAS number: 46921-17-9
- 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:
- 2010-01-19 to 2010-02-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- ECVAM protocol validated in April 2007 (version 1.2 of September 2005, 1.8 of February 2009)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole
- EC Number:
- 686-853-5
- Cas Number:
- 46921-17-9
- Molecular formula:
- C16H31NO
- IUPAC Name:
- 4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Test material form:
- liquid
- Details on test material:
- Other name of 4,4-Dimethyl-2-undecyl-2-oxazoline : cycloceramide
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Purity : 96,3 %
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Reconstructed human epidermis from SkinEthic Laboratories company
- Source strain:
- not specified
- Details on animal used as source of test system:
- Kit EPISKIN (reconstructed human epidermis) constituted:
- Type I collagen matrix surfaced with a type IV collagen film.
- stratified and differentiated epidermis derived from human keratinocytes, obtained after 13 days of culture. - Justification for test system used:
- The in vitro test (EPISKIN model) is a reliable and relevant model for predicting skin irritation and can be used as an in vivo test replacement to distinguish between skin irritants and non-irritants according to EU classification standards.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- - pH of the test material: not applicable because the test material is lipophilic
- Duration of exposure: 15 +/- 0.5 minutes
- Deposit quantity: 10µL
- Post exposure observation period: incubation; 42 +/- 1 hour / Coloration: 3 hours +/- 5 minutes
- Control group: positive control: PBS / negative control: SDS (CAS number 151-21-3) at 5% in distilled water
- vehicle: no
- removal of test substance: 25 mL of PBS
-criteria:
Viability < 50% : irritant
Viability > 50% and IL-1a > 60 pg/mL : irritant
Viability > 50% and IL-1a < 60 pg/mL : non irritant - Control samples:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount/concentration applied:
- MTT: final concentration of the test medium: 0.3 mg/mL.
Deposit of 10µL of test material or control (positive or negative) in 90µL of water. - Duration of treatment / exposure:
- 15 +/- 0.5 minutes
- Duration of post-treatment incubation (if applicable):
- Post-treatment incubation (CO2) : 42 +/- 1 hours
- Number of replicates:
- 2 tests per item (positive control, negative control, test material) and 3 replicates per test
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- MTT
- Run / experiment:
- 1
- Value:
- ca. 58.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- IL-1a concentration = 185,6 pg/mL
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- MTT
- Run / experiment:
- 2
- Value:
- ca. 56.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- IL-1a concentration = 173,1 pg/mL
Any other information on results incl. tables
Test material | Test | % relative viability (dosage of MTT) | final concentration of IL-1a |
No vehicle | 1 | 58.9 +/- 0.02 | 185,6 pg/mL |
2 | 56.5 +/- 0.00 | 173.1 pg/mL | |
Average | 57.70 +/- 1.70 | 179.35 +/- 8.84 pg/mL |
Applicant's summary and conclusion
- Conclusions:
- According to the results obtained under the experimental conditions adopted, the test element called "CYCLOCERAMIDE (R)" applied on reconstituted human epidermis, can be qualified as skin irritant
(4,4-Dimethyl-2-undecyl-2-oxazoline = Cyclocéramide (R)) - Executive summary:
objective: to predict and classify the cutaneous irritating potential of an ingredient, by evaluation of its effect on a human epidermis reconstructed model EPISKIN, in agreement with the standards of European Classification.
Conclusion: According to the results obtained under the experimental conditions adopted, the test element called "CYCLOCERAMIDE (R)" applied on reconstituted human epidermis, can be qualified as skin irritant.
Test material Test % relative viability (dosage of MTT) final concentration of IL-1a No vehicle 1 58.9 +/- 0.02 185,6 pg/mL 2 56.5 +/- 0.00 173.1 pg/mL Average 57.70 +/- 1.70 179.35 +/- 8.84 pg/mL
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