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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-09-24 to 2014-09-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The department of health of the government of the United Kingdom
Test material
- Reference substance name:
- Amides, C18, branched and linear
- Molecular formula:
- Not applicable as UVCB
- IUPAC Name:
- Amides, C18, branched and linear
- Test material form:
- solid: pellets
- Details on test material:
- - Name of test material (as cited in study report): Amides, C18, branched and linear
- Physical state: extremely pale yellow granular solid
- Lot/batch No.: 202637
- Expiration date of the lot/batch: 20 April 2016
- Storage condition of test material: at RT, protect from light
- Analytical purity: 100%
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: human-derived epidermal keratinocytes (EpiSkin)
- Details on test animals or test system and environmental conditions:
- TEST METHOD
EpiSkinSM tissues are provided as kits (SkinEthic)
The test was carried out with the reconstituted threedimensional human skin model EPISKINSM (SkinEthic). The skin model consists of normal (noncancerous), adult humanderived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagencoated cell culture inserts. A highly differentiated and stratified epidermis model is obtained after 13 day culture period comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
ADAPTATION TO CELL CULTURE CONDITIONS
Upon receipt, tissues were transferred into 12 well plates containing 2 mL pre-warmed maintenance medium per well and pre-incubated in a humidified incubator for at least 24 h (37 °C, 5% CO2) before use.
INCUBATION CONDITIONS (INCUBATOR)
Temperature (°C): 37
CO2 gas concentration (%): 5
Test system
- Type of coverage:
- other: in vitro system
- Preparation of test site:
- other: intact reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent control tissues treated with the DPBS served as negative controls, positive controls were exposed to 5% SDS
- Amount / concentration applied:
- TEST MATERIAL:
Amount(s) applied (volume or weight with unit): 10 mg
NEGATIVE CONTROL SUBSTANCE:
Amount(s) applied (volume or weight with unit): 10 μL DPBS
POSITIVE CONTROL SUBSTANCE:
Positive control substance: 10 μL SDS, 5% (w/v) - Duration of treatment / exposure:
- 15 min
- Observation period:
- 42 h
- Number of animals:
- Not applicable. The test was performed in triplicates for each treatment and control group.
- Details on study design:
- TEST SITE:
- Area of exposure: 0.38 cm²
REMOVAL OF TEST SUBSTANCE:
- Washing: The test item was washed from the skin surface with phosphate buffered saline.
- Time after start of exposure: 15 min
- Post-treatment incubation period: 42 h
CELL VIABILITY MEASUREMENTS:
For determining alterations in cell viability, MTT reduction assays were performed 42 h after the incubation period. Therefore, tissues were incubated in 2 mL pre-warmed MTT solution for 3 h at 37 °C and 5% CO2. After aspiration of the MTT solution, tissues were dried. Extraction of the formazan product was carried out in 500 μL isopropanol. The optical density was measured at 562 nm wave length in a microplate reader (Anthos 2001 microplate reader).
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability (%)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of negative controls (PBS). Time point: 42 h . Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 11.1
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of positive controls (SDS). Time point: 42 h. Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 97.8
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of the test item. Time point: 42 h . Reversibility: other: not applicable. (migrated information)
In vivo
- Irritant / corrosive response data:
- In comparison to the untreated control for the test item a cell viability of 97.8% was measured after 42 h. Based on the results of the study the test item is non-irritant.
Any other information on results incl. tables
Table 1: Mean OD562 values and percentage viabilities for the negative control item, positive control item and test item
|
Negative control |
Positive control |
Test item |
||||||
Tissue sample |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
OD562 |
0.787 |
0.825 |
0.781 |
0.095 |
0.071 |
0.099 |
0.735 |
0.822 |
0.785 |
OD562(mean values of replicates) |
0.798 |
0.088 |
0.781 |
||||||
SD |
0.02 |
0.02 |
0.04 |
||||||
Viability (%) |
100 |
11.1 |
97.8 |
SD: Standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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