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Diss Factsheets
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EC number: 947-548-5 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to 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:
- other: MatTek Corporation Epiocular ia vitro toxicity testing systern.
- Principles of method if other than guideline:
- "MatTek's patented Epiocular comeal Model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a stratified, squarnous epithelium similm to that found in the cornsa. The epidermal cells, which are cultured on specially prepared cell culture inserts using serum free medium, differentiate to form a multilayered structure which closely parallelsthecornealepithelium..."This system"...providesapredictive,morphologically relevant in vitro means to assess ocular irritancy."
EpiOcular, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure utilizes a water-soluble, yellow, tetrazolium salt (MTT {3-[4,5-dimethylthiazol-2-yll-2,5-diphenyl-tetrazolium bromide])" which is reduced by succinate dehydrogenase in the mitochondria of viable cells to a purple, insoluble formazan derivative.Substances which damage this mitochondrial enzyme inhibit the reduction of the tehazolium salt.The amount of MTT reduced by a culture is therefore proportional to the number of viable cells - GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of N,N-Bis(2-hydroxypropyl)(C6-C18 even numbered and C18 unsatd)amides and bis(2-hydroxypropyl)ammonium myristate
- Molecular formula:
- No molecular formula. UVCB reaction mass.
- IUPAC Name:
- Reaction mass of N,N-Bis(2-hydroxypropyl)(C6-C18 even numbered and C18 unsatd)amides and bis(2-hydroxypropyl)ammonium myristate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- human
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- The Sponsor requested the test article's irritation potential at l00%. The test article, at 100%, is water soluble and has a specific Savity greater than 0.95 g/ml. Therefore, as per MatTek's protocolo the test article was diluted to 20% in distilled watsr. After the appropriate tissue preparation, 100 microliters of the test article and the negative control (distilled water) were added to the Millicells containing the Epi0cular samples.
- Duration of treatment / exposure:
- Total time of 4 hours
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- The six (6) well plates containing the dosed EpiOcular samples were then incubated at 37C, five (5)% carbon dioxide and > 90% humidity. After the appropriate exposure period, each insert was individually removed from its plate and rinsed with phosphate buffered saline (PBS) to remove any residual material. Each was then rinsed a second and third time
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: % viability (ET-50) in minutes
- Value:
- 122.1
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- other: Draize equivalent
- Value:
- 4.5
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
Any other information on results incl. tables
A Molecular Devices SpectraMax M5 Microplate Reader was used to determine the absorbance of each extract at 570nm. With the absorbance of the negative control (distilled water) defined as 100%, the percent absorbencies of the test article were determined. The
percentages listed below directly correlate with the cell metabolism in the EpiOcular samples.
(20% - 4 hrs.) - % viability = 39, % inhibition = 61
(20% - 1 hr.) - % viability = 61, % inhibition = 39
(20% - 20 mins.) - % viability = 75, % inhibition = 25
When possible, using a semilog scalg the percent viabilities for the article were plotted on the linear y axis versus the dosing time on the log x axis. By interpolation, the time at which the percent viability would be 50% was determined (ET-50).
As a general guideline (provided by MatTek) the following equation can be used to estimate the rabbit Draize eye score:
Draize : 4.7 4 + 101.7/(ET-50)^0.5
Based on the literature (Kay, J.H. and Calan&a J.C., "lnterpretation of eye irritation tests,"J Soc. Cosmetic Chem., 13, 281-289 (1962)), the ocular initancy estimated potential has been categorized by MatTek into the following groups, based on the Draize score:
Under the conditions of this test, the Colaliquid DC-5 100% Active test article, at 20%, elicited in vitro results which indicate that its ET-50 is 122.1 minutes. Therefore, at 100%, the test article's estimated Draize ocular iritation score is approximately 4.5 with a "minimally irritating" irritancy classification.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, the results indicate that the Colaliquid DC-5 100% Active test article, at 100%, has a non-irritating/minimally irritating classification.
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