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EC number: 295-171-3 | CAS number: 91845-01-1
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19.06.2018 - 15.08.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- In Vitro Skin Corrosion: reconstructed human epidermis (RHE) test method”, (adopted 29 July 2016).
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C12-18 and C18-unsatd., reaction products with chloroacetic acid and 2-(dimethylamino)ethanol and N,N-dimethyl-1,3-propanediamine
- EC Number:
- 295-171-3
- EC Name:
- Fatty acids, C12-18 and C18-unsatd., reaction products with chloroacetic acid and 2-(dimethylamino)ethanol and N,N-dimethyl-1,3-propanediamine
- Cas Number:
- 91845-01-1
- Molecular formula:
- C24H48NO4, C25H51N2O3
- IUPAC Name:
- 2-(dimethylamino)ethyl hexadecanoate; 2-(dimethylamino)ethyl octadecanoate; N-[3-(dimethylamino)propyl]hexadecanamide; N-[3-(dimethylamino)propyl]octadecanamide
- Test material form:
- solid: bulk
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: Human EpiDerm Skin Model, EPI-200
- Cell type:
- other: Human-derived epidermal keratinocytes
- Cell source:
- other: Multilayered, highly differentiated model of the human epidermis
- Source strain:
- other: EPI-200, Lot no.: 28811, kit L and M
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- water
- Details on test system:
- EpiDerm Skin Model (EPI-200, Lot no.: 28811, kit L and M
The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized 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. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts. - Control samples:
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- 51.1 to 65.0 mg
- Duration of treatment / exposure:
- 3 min., 1 hour
- Duration of post-treatment incubation (if applicable):
- 3 min.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour, 3 min.
- Value:
- >= 88 - <= 96
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not corrosive
- Conclusions:
- In conclusion, 03590 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
- Executive summary:
The study procedures described in this report were based on the most recent OECD and EC guidelines. Batch 51716 of 03590 was a beige brown solid. Skin tissue was moistened with 25 µL of
Milli-Q water and at least 25 mg of 03590 was applied directly on top of the skin tissue. The positive control had a mean relative tissue viability of 8.7% after the 1-hour exposure. The absolute mean OD 570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit 2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was <10%, indicating that the test system functioned properly. Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with 03590 compared to the negative control tissues was 96% and 88%, respectively. Because the mean relative tissue viability for 03590 was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment 03590 is considered to be not corrosive.
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