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EC number: 800-884-5 | CAS number: 1154308-86-7
- 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:
- 11 September 2012 to 08 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD (2010), In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, OECD Guidelines for the Testing of Chemicals No. 439, OECD, Paris.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM Scientific Advisory Committee (ESAC) Statement on the Validity of In Vitro Tests for Skin Irritation (2007).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM Skin Irritation Validation Study. Validation of the EpiSkin® Irritation Test – 42 Hours Assay for the Prediction of Acute Skin Irritation of Chemicals, L’Oreal Recherche, January 2005.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM Skin Irritation Validation Study (SIVS). Performance Standards for Applying Human Skin Models to In Vitro Skin Irritation Testing (2007).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- OECD (2010), In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, OECD Guidelines for the Testing of Chemicals No. 439, OECD, Paris.
- Deviations:
- no
- Principles of method if other than guideline:
- in vitro skin irritation using the EpiSkin model.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide
- EC Number:
- 800-884-5
- Cas Number:
- 1154308-86-7
- Molecular formula:
- C11 H23 N1 O2
- IUPAC Name:
- N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide
- Test material form:
- other: liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEST SYSTEM
- SkinEthic Episkin - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL
- Surface area of the EpiSkin was ca 0.38 cm2.
- Application rate was ca 26.3 μL/cm2. - Duration of treatment / exposure:
- 15 minutes.
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3 replicates
Test animals
- Species:
- other: in vitro
Test system
- Details on study design:
- TEST SITE
- Area of exposure: 0.38 cm2; RATE OF 26.3 μL/cm2.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed with 25 mL PBS and blotted dry on tissue paper.
- Time after start of exposure: 15 mins
INITIAL ASSESSMENT OF TOXICITY
Prior to the conduct of the irritation assay, a preliminary test was conducted to assess the intrinsic ability of the test item to reduce methylthiazoldiphenyl-tetrazolium bromide (MTT) to formazan. The substance coating additives did not reduce MTT to formazan.
PROCEDURE OF THE MAIN TEST
The dermal irritation potential was assessed by applying 10 μL of the substance coating additives to the exposed surface of three EpiSkin tissues for 15 min. The surface area of the EpiSkin was 0.38 cm2, therefore the application rate was 26.3 μL/cm2. After the 15 min exposure period, the test item was washed from the surface of the EpiSkin using Dulbecco’s phosphate-buffered saline (PBS). The EpiSkin tissues were then incubated for a recovery period of 42 h in a humidified incubator, set to maintain temperature and CO2 levels of 37°C and 5%, respectively. Following incubation, the tissues were transferred to assay medium containing MTT (0.3 mg/mL) and returned to the incubator for 3 h. Biopsies of the EpiSkin membranes were removed, added to acidified isopropanol, and refrigerated for ca 68 h in order to extract the formazan. The formazan production (cell viability) was assessed by measuring the optical density of the extracts at a wavelength of 550 nm. Three replicates of the positive control, aqueous sodium dodecyl sulphate (SDS, CAS 151-21-3) solution (5%, w/v), and the negative control, PBS, were tested in parallel to demonstrate the efficacy of the assay. The viability of each individual EpiSkin tissue was calculated as a percentage of the mean negative control viability (defined as 100%).
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 9.56
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- Basis: mean mean of 3 replicates. Time point: 42 h. Reversibility: no data. Remarks: Reduced viability of cells in the EpiSkin® model.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 (irritant) based on CLP criteria
- Conclusions:
- Under the conditions of the in vitro EpiSkin® study, the test substance was demonstrated to be an irritant to skin
- Executive summary:
A study was conducted to determine dermal irritation potential of the test substance, in an EpiSkin® in vitro irritation test, according to OECD 439, in compliance with GLP. Prior to the conduct of the irritation assay, a preliminary test was conducted to assess the intrinsic ability of the test substance to reduce methylthiazoldiphenyl-tetrazolium bromide (MTT) to formazan. The test substance did not reduce MTT to formazan. The dermal irritation potential was assessed by applying 10 μL of the test substance to the exposed surface of three EpiSkin tissues for 15 min. The surface area of the EpiSkin was 0.38 cm2, therefore the application rate was 26.3 μL/cm2. After the 15 min exposure period, the test substance was washed from the surface of the EpiSkin using Dulbecco’s phosphate-buffered saline (PBS). The EpiSkin tissues were then incubated for a recovery period of 42 h in a humidified incubator, set to maintain temperature and CO2 levels of 37°C and 5%, respectively. Following incubation, the tissues were transferred to assay medium containing MTT (0.3 mg/mL) and returned to the incubator for 3 h. Biopsies of the EpiSkin membranes were removed, added to acidified isopropanol, and refrigerated for ca 68 h in order to extract the formazan. The formazan production (cell viability) was assessed by measuring the optical density of the extracts at a wavelength of 550 nm. Three replicates of the positive control, aqueous sodium dodecyl sulphate (SDS) solution (5%, w/v), and the negative control, PBS, were tested in parallel to demonstrate the efficacy of the assay. The viability of each individual EpiSkin tissue was calculated as a percentage of the mean negative control viability (defined as 100%). Exposure to the test substance resulted in a mean EpiSkin viability of 9.56% ± 3.26% of the negative control value. Exposure to the positive control, aqueous SDS solution (5%, w/v), resulted in a mean EpiSkin viability of 13.36% of the negative control value. Under the conditions of the in vitro EpiSkin® study, the test substance was demonstrated to be an irritant to skin (Blackstock, 2013).
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