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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
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 May 16, 2017 to June 16, 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- see "Principles of method if other than guideline
- Principles of method if other than guideline:
- Optical Density (OD) values obtained with blanks were higher than 0.1 (0.191) causing a deviation from Acceptance Criteria. However, this is not considered to be an issue in the interpretation of this study data.
- 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
In vitro test system
- Test system:
- human skin model
- Source species:
- other:
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: reconstructed human epidermal model
- Justification for test system used:
- Initially the predictive capacity of the modified EpiDerm™ Skin Irritation Test (SIT) test method, using MatTek EpiDermTM tissue model EPI-200, underwent full prospective validation from 2003-2007. The test method components of this method were used to define the essential test methods components of the original and updated ECVAM Performance Standards (PS). A modification of the original EpiDerm™ SIT was validated using the original ECVAM PS in 2008. In 2008, ESAC concluded that the Modified EpiDerm™ SIT has sufficient accuracy and reliability for prediction of R38 skin irritating and no-label (non-skin irritating) test substances.
- Vehicle:
- other: Sterile Dulbecco’s Phosphate Buffered Saline
- Details on test system:
- The reconstructed human epidermal model EpiDermTM (EPI-200-MatTek Corporation) consists of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differentiated model of the human epidermis. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.
Lot No.: 25819
Keratinocyte Strain: 00267
MatTek’s EpiDermTM model has been extensively characterised for multiple parameters including morphology, tissue viability, skin barrier function and sterility. QC results for the specific lot of models received (Lot# 25819) were checked in-house for MatTek acceptance ranges with the following outcome:
- Morphology - PASS
- Tissue viability - PASS
- Skin barrier function (ET50 value for 1 % Triton X-100) where ET50 is the time taken for 1 % Triton X-100 to reduce the viability of the skin model to 50 % relative to the negative control)- PASS
- Sterility testing showed no contamination during long term antibiotic and antimycotic free culture- PASS - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Nominal 25 mg neat test substance
- Duration of treatment / exposure:
- 60 minutes (25 minutes at room temperature and 35 minutes at 37 °C, 5 % CO2)
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- Three tissues per condition (n=3).
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 93.66
- Vehicle 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 DPBS) tissues is ≥ 0.8 and ≤ 2.8
Result for the test: 1.777
- The mean of the positive control relative percentage viability must be ≤ 20 % of the mean of the negative controls.
Result for the test: 3.8 %
- The standard deviation of OD values for triplicate skin models in each experimental condition must be < 18 %
Results for the test:
NC: 5 %
PC: 0.72 %
TA2: 5.89 %
Optical Density (OD) values obtained with blanks were higher than 0.1 (0.191) causing a deviation from acceptance criteria 4. However, the spectrophotometer was fully validated and had passed all required tests. The OD values for blanks observed in this study are consistent with historical data using this spectrophotometer in the XCellR8 laboratory and meet our current internal acceptance criteria of blank OD values <0.194 (mean of XCellR8 historical data, based on blanks obtained during the last 66 studies), therefore this is not considered to be an issue in the interpretation of this study data.
This SOP and guideline deviation was not considered to have affected the integrity or interpretation of the results as no equivocal results were obtained.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met (not classified)
- Conclusions:
- Under the study conditions, based on the percentage of viability of 93.66 %, the test substance was concluded to be non-irritant to the skin.
- Executive summary:
A study was conducted to determine the skin irritation potential of the test substance, C16-18 AMP, using Reconstructed Human Epidermis (RhE) Test Method, according to OECD 439 Guideline, in compliance with GLP. Three tissues of the human skin model EpiDermTM were treated with the test substance, positive or negative control for 60 minutes (25 minutes at room temperature and 35 minutes at 37 °C, 5 % CO2) and 42 h post incubation period. Tissues were pre-wetted with 25 μl of DPBS (Sterile dulbecco’s phosphate buffered saline) prior to topical application of 25 mg of the neat test substance. 30 μl of DPBS was used as negative control and 5 % of sodium dodecyl sulphate solution in water was used as positive control. Subsequently, viability of the tissues was assessed and compared to the negative control. Under the study conditions, based on the percentage of viability of 93.66 %, the test substance was concluded to be non-irritant to the skin (XCellR8, 2017).
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