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EC number: 938-458-7 | CAS number: 1443751-77-6
- 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:
- 2012-04-25 to 2012-04-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439 (In Vitro Skin Irritation: Human Skin Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-(2-hydroxyethyl)decanamide; N-(2-hydroxyethyl)octanamide
- EC Number:
- 938-458-7
- Cas Number:
- 1443751-77-6
- Molecular formula:
- UVCB substance: Amides, C8-10 (even-numbered), N-hydroxyethyl
- IUPAC Name:
- N-(2-hydroxyethyl)decanamide; N-(2-hydroxyethyl)octanamide
- Test material form:
- solid: flakes
Constituent 1
Test animals
- Species:
- other: reconstructed human epidermis model EpiDerm™ (EPI-200-KIT)
- Details on test animals or test system and environmental conditions:
- The EpiDerm™ tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
Test system
- Amount / concentration applied:
- Approximately 11 to 13 mg of fine ground test material was applied to the tissues and wetted each with 15 μL deionised water. It was taken care that the test item was evenly distributed on the tissues. For the positive and negative controls 10 μL were dosed per tissue.
- Duration of treatment / exposure:
- Positive control 15 min (± 1 min) (5% SLS)
Negative control 15 min (± 1 min) Deionised water
Test substance 15 min (± 1 min) - Observation period:
- after washing process post incubation period of 42 h
- Number of animals:
- The test was performed in triplicate
Results and discussion
In vivo
- Irritant / corrosive response data:
- Test substance: mean viability 5.3 (+/- 0.7) %
Negative control: mean viability 100 (+/- 10.5) %
Positive control: mean viability 20.8 (+/- 1.0) %
Any other information on results incl. tables
Test substance: mean viability 5.3 (+/- 0.7) %
Negative control: mean viability 100 (+/- 10.5) %
Positive control: mean viability 20.8 (+/- 1.0) %
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Topical application of the test substance on top of the stratum corneum of the reconstructed human epidermis model EpiDerm™ (in triplicate) resulted in a mean cell viability of 5.3 % when compared to the corresponding negative control. According to the evaluation scheme of OECD test guideline 439 the test substance has to be predicted as irritating to the skin.
- Executive summary:
The skin irritating potential of the test substance Amides, C8-10, N-(hydroxyethyl) has been investigated using an in-vitro reconstructed human epidermal model (RHE), according to OECD guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, July 2010).
EpiDerm™ RHEs (EPI-200-KIT) were topically exposed to 11 to 13 mg of fine ground test material for 15 min. The cell viability was determined after an additional 42 h (± 2 h) post incubation period. For the analysis of the tissue viability the Standard MTT Assay was used. The viability of the negative control (Deionised water) was set to 100%.
The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 5.3% (threshold for irritancy: ≤ 50%), consequently the test item was irritant to skin.Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.
The sensitivity and accuracy of the used test system has been demonstrated with the reference substance SLS (5% aqueous solution). A mean cell viability of 20.8 % in relation to the corresponding negative control Deionised water was determined.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test substance Amides, C8-10, N-(hydroxyethyl) is irritant to skin.
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