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EC number: 273-159-9 | CAS number: 68951-62-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 25, 2017 to June 22, 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octadecanoic acid, reaction products with 2-amino-2-methyl-1-propanol
- EC Number:
- 273-159-9
- EC Name:
- Octadecanoic acid, reaction products with 2-amino-2-methyl-1-propanol
- Cas Number:
- 68951-62-2
- Molecular formula:
- C20H41NO2 (C16 chain representative) & C22H45NO2 (C18 chain representative)
- IUPAC Name:
- N-(1-hydroxy-2-methylpropan-2-yl)hexadecanamide; N-(1-hydroxy-2-methylpropan-2-yl)octadecanamide
- Test material form:
- solid
- Details on test material:
- Appearance: Off white cream
Constituent 1
Test animals / tissue source
- Species:
- other: EpiOcularTM tissue model (OCL-200-MatTek Corporation)
- Strain:
- other: Keratinocyte 4F1188
- Details on test animals or tissues and environmental conditions:
- Test system:
The EpiOcularTM tissue model (OCL-200-MatTek Corporation) is composed of stratified human keratinocytes in a three-dimensional structure, reflecting the morphology and function of the human corneal epithelium found in vivo.
Lot No.: 23787
Keratinocyte Strain: 4F1188
MatTek’s EpiOcularTM system consists of normal, human-derived keratinocytes which have been cultured to form a stratified, squamous epithelium similar to that found in the cornea. Cultured on specially prepared cell culture inserts using serum-free culture medium, the cells differentiate to form a multi-layered structure with progressively stratified, but not cornified cells which closely parallel the corneal epithelium (for information see www.mattek.com). QC results for the specific lot of models received (Lot# 23787) were checked in-house for MatTek acceptance ranges with the following outcome:
- Morphology - TBD
- Tissue viability - TBD
- Skin barrier function (ET50 value for 0.3 % Triton X-100) where ET50 is the time taken for 0.3 % Triton X-100 to reduce the viability of the skin model to 50 % relative to the negative control) - TBD
- Sterility testing showed no contamination during long term antibiotic and antimycotic free culture - TBD
Test system
- Vehicle:
- other: PBS (Sterile Dulbecco’s Phosphate Buffered Saline)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 20 µl of PBS (Sterile Dulbecco’s Phosphate Buffered Saline) plus 50 mg of test substance.
- Duration of treatment / exposure:
- 6h ± 15 minutes post-treatment immersion, and 18 hours ± 15 minutes post-treatment incubation.
- Duration of post- treatment incubation (in vitro):
- 25 ± 2 minutes
- Number of animals or in vitro replicates:
- Three tissues per condition (n=3).
- Details on study design:
- Preliminary test:
The test substance was first checked for its potential for MTT interference and solvent interference (water and isopropanol).
Main test overview:
Day 0: On the day of receipt, EpiOcularTM tissues were pre-incubated overnight at 37 °C, 5 % CO2.
Day 1: Exposure to and removal of test and reference substances (50 mg of test substance or 50 µl of reference substances for 6h ± 15 minutes, followed by a 25 ± 2 minutes post-treatment immersion, and 18 hours ± 15 minutes post-treatment incubation).
Day 2: End of MTT viability test, readings at 570 nm without reference filter.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % viability
- Value:
- 112.829
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- All validity criteria for the test were met:
- Criteria: the mean OD570 of the negative control (treated with sterile water) tissues is ≥ 0.8 and ≤ 2.5.
Result for the test: 1.071
- The mean of the positive control relative percentage viability is below 50% of negative control viability after 6 hours exposure.
Result for the test: 36.696
- The SD between three tissues replicates should not exceed 18 % in the same run (for negative and positive control tissues and tissues of test substances).
Results for the test:
NC: 11.368
PC: 7.373
TA2: 7.528
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met (not classified)
- Conclusions:
- Under the study conditions, based on the percentage viability of 112.829%, the test substance was concluded to be non-irritant to the human eye
- Executive summary:
A study was conducted to determine the eye irritation potential of the test substance, C16-18 AMP using Reconstructed human Cornea-like Epithelium (RhCE) test method, according to OECD 492 Guideline, in compliance with GLP. Three tissues of the EpiOcularTM tissue model were treated with the test substance, positive or negative control. Tissues were pre-wetted with 20 μL of PBS (Sterile Phosphate Buffered Saline) prior to topical application of approximately 50 mg of neat test substance. Sterile water was used as negative control and methyl acetate as positive control. After 6 h exposure on the surface of EpiOcularTM reconstructed ocular epithelium and 18 h post-incubation time, the viability of the tissues was assessed and compared to a negative control. The MTT viability test readings were conducted at 570 nm without reference filter. Under the study conditions, based on the percentage viability of 112.829%, the test substance was concluded to be non-irritant to the human eye (XCellR8, 2017).
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