Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 246-929-7 | CAS number: 25383-99-7
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Skin toxicity of surfactants: Structure/toxicity relationships
- Author:
- Lemery E., Briancon S., Chevalier Y., Bordes C., Oddos T., Gohier A., Bolzinger M.-A.
- Year:
- 2 015
- Bibliographic source:
- Colloids and Surfaces A: Physicochem. Eng. Aspects 469 (2015) 166–179
Materials and methods
- Principles of method if other than guideline:
- A cytotoxicity test was conducted on reconstructed human epidermis (RhE) tissues. The test substance was topically applied to the RhE tissues and the tissues were incubated at 37 °C, in the presence of 5% CO2 and 95% humidity, for 72 h. Following exposure to the test substance, the RhE growth medium was screened for the primary inflammation marker Interleukin-1α (IL-1α) and the delayed inflammation marker Interleukin-8 (IL-8).
- GLP compliance:
- no
- Remarks:
- Investigation reported in a scientific publication
- Type of study:
- other: detection of the inflammation markers Interleukin IL-1α and IL-8
Test material
- Reference substance name:
- Sodium 2-stearoyllactate
- EC Number:
- 246-929-7
- EC Name:
- Sodium 2-stearoyllactate
- Cas Number:
- 25383-99-7
- Molecular formula:
- This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molecular weight, SMILES, InChI and structural formula cannot be given.
- IUPAC Name:
- sodium 2-hydroxy-2-methyl-3-oxoicosanoate
Constituent 1
In vitro test system
- Details on the study design:
- A cytotoxicity test was conducted on reconstructed human epidermis (RhE) tissues. Upon delivery, RhE devices were transferred into 3 mL of RhE aqueous growth medium, free from antibiotics and hydrocortisone, and treated immediately.Three reconstructed human epidermis (RhE) tissues were treated with 10 µL of an emulsion containing the test substance at a concentration of 3%. The test substance emulsion was topically applied at the center of the RhE surface. Four untreated RhE tissues were used as controls. Each sample (test substance and control) was placed in 3 mL of aqueous growth medium and incubated at 37 °C, in the presence of 5% CO2 and 95% humidity, for 72 h.
After the incubation period, the RhE growth medium was screened for the primary inflammation marker Interleukin-1α (IL-1α) and the delayed inflammation marker Interleukin-8 (IL-8). The collected RhE growth medium was labeled using the Fluorokine MAP Human Base Kit A and analysed by flow cytometry using the Bioplex-200 instrument (Bio-Rad, Marnes-la-Coquette, France), a device relying on a Luminex Multi-Analyte Profiling technology.
Substances are considered to induce skin sensitisation when the extracellular IL-8 > 1L-1α, and irritants when extracellular IL-8 < IL-1α.
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Run / experiment:
- other: 72 h
- Parameter:
- other: Release of Interleukin-1a (IL-1α)
- Value:
- 0.582 %
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Run / experiment:
- other: 72 h
- Parameter:
- other: Release of Interleukin-8 (IL-8)
- Value:
- 3.407 %
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Other effects / acceptance of results:
- Sodium stearoyl lactylate caused a significant release of IL-8 and no significant IL-1α release. The IL-8/IL-1α ratio was 5.85 (i.e. > 1). The value for release of IL-8 (3.407) was above the threshold of 3, whereas the value for the release of IL-1α (0.582) was not.
Substances applied to the skin can be considered allergens when the extracellular IL-8 > 1L-1α, and as irritants when extracellular IL-8 < IL-1α. Sodium stearoyl lactylate was predicted to be an allergen.
Applicant's summary and conclusion
- Interpretation of results:
- other: Sodium stearoyl lactylate was predicted to be an allergen.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.