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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Sept - 11 Oct 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted in 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- adopted in 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
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
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDermTM (EPI-200)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-200-SIT) (MatTek Corporation, 82105 Bratislava, Slovakia)
- Tissue batch number(s): 30830
- Date of initiation of testing: 12 Sept 2019
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 35 min at 37 ± 1.5 °C and 5 ± 0.5% CO2 in Dulbecco's Minimum Essential Medium (DMEM) followed by 25 min in a sterile bench at room temperature
- Temperature of post-treatment incubation: approx. 42 h at 37 ± 1.5 °C and 5 ± 0.5% CO2 in DMEM
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: rinsed with Phosphate Buffered Saline (PBS) several times
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 300 μl/well
- Incubation time: 3 h ± 5 min
- Spectrophotometer: microplate reader (Versamax® Molecular Devices, Software SoftMax Pro Enterprise version 4.7.1)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the EpiDerm™ tissue was assessed by an MTT cell viability test. The determined OD (540 - 570 nm) was 1.946 ± 0.146 (acceptance criteria: 1.0 - 3.0).
- Barrier function: The barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon application of 100 µL of 1% Triton X-100. The ET-50 value was determined to be 5.05 h (acceptance criteria: 4.77-8.72 h).
- Contamination: The cells used to produce the EpiDerm™ tissue were screened for the presence of viruses, bacteria, yeast and other fungi. No contamination was detected.
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Since the test substance did not directly reduce the MTT solution, an additional functional check was not performed.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: single experiment
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant or corrosive to skin if the viability after 1 h exposure is ≤ 50%.
- The test substance is considered to be non-irritant to skin if the viability after 1 h exposure is > 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 25 mg (corresponding to 39.7 mg/cm2) + 25 µL DPBS - Duration of treatment / exposure:
- 35 min at 37 °C and 25 min at RT
- Duration of post-treatment incubation (if applicable):
- Approx. 42 h
- Number of replicates:
- Triplicates for each treatment and control group
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 3 tissues
- Run / experiment:
- 1 h exposure
- Value:
- 100.16
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct-MTT reduction: Since the test substance did not directly reduce MTT, an additional test with freeze-killed or viable tissues was not performed.
- Colour interference with MTT: The test substance did not change the colour, when mixed with deionised water and thus passed the colour interference pre-test. Also its intrinsic colour was not intensive.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
The technical proficiency of the test facility was demonstrated. Appropriate data are provided in 'Any other information on results incl. tables' below.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD of the tissue replicates treated with the negative control was ≥ 0.8 and ≤ 2.8 for every exposure time (values between 1.689 and 1.783).
- Acceptance criteria met for positive control: The mean viability of the tissue replicates treated with the positive control for 1 h was < 15% compared to the negative control (4.32%).
- Acceptance criteria met for variability between replicate measurements: The standard deviations between the three tissue percentage viability values of each group (test item, positive and negative controls) in the main test were below 18.
Any other information on results incl. tables
Table 1: Details on results |
||||||||||
Treatment Group |
Tissue No. |
OD 570 nm |
Mean OD of 3 Wells |
Mean OD of 3 Wells blank corrected |
Mean OD of 3 tissues |
Rel. Viability [%] Tissue 1, 2 + 3 |
Standard Deviation |
Mean Rel. Viability [%] |
||
Well 1 |
Well 2 |
Well 3 |
||||||||
Blank |
|
0.038 |
0.039 |
0.039 |
0.039 |
|
||||
Negative Control |
1 |
1.734 |
1.713 |
1.736 |
1.727 |
1.689 |
1.751 |
96.469 |
0.054 |
100.0 |
2 |
1.831 |
1.818 |
1.807 |
1.819 |
1.780 |
101.677 |
||||
3 |
1.825 |
1.783 |
1.858 |
1.822 |
1.783 |
101.854 |
||||
Positive Control |
1 |
0.112 |
0.126 |
0.114 |
0.117 |
0.079 |
0.076 |
4.494 |
0.005 |
4.32 |
2 |
0.117 |
0.117 |
0.117 |
0.117 |
0.078 |
4.469 |
||||
3 |
0.108 |
0.109 |
0.109 |
0.109 |
0.070 |
3.989 |
||||
Test Item |
1 |
1.861 |
1.795 |
1.783 |
1.813 |
1.774 |
1.753 |
101.336 |
0.082 |
100.16 |
2 |
1.708 |
1.702 |
1.694 |
1.701 |
1.663 |
94.982 |
||||
3 |
1.838 |
1.886 |
1.864 |
1.862 |
1.824 |
104.175 |
Table 2: Historical control data |
|||
Positive Control; OD at 570 nm after exposure to 5% SDS solution in deionized water (MatTek) |
Negative Control OD at 570 nm DPBS (MatTek) |
||
Tissue Viability [%] |
3.89 |
Mean OD |
1.69 |
Standard Deviation |
1.01 % points |
Standard Deviation |
0.19 |
Range of Viabilities |
2.24 % - 6.19 % |
Range of OD* |
1.28 - 2 |
Mean OD |
0.07 |
* should be 0.8 - 2.8 (OECD 439) or 1.0 - 2.5 (MatTek) |
|
Standard Deviation |
0.02 |
||
Range of OD |
0.03 - 0.11 |
||
Data of 50 sets of controls shared between 195 studies performed from August 2015 until May 2019 (p.p.: percentage points) |
Table 3: Technical proficiency |
||
Proficiency Substance |
Viability [%] |
Category |
Naphtalene acetic acid |
101.7 |
No Cat. |
Isopropanol |
85.5 |
No Cat. |
Methyl stearate |
91.1 |
No Cat. |
Heptyl butyrate |
109.0 |
No Cat. |
Hexyl salicylate |
98.1 |
No Cat. |
Cyclamen aldehyde |
24.1 |
Cat. 2 |
1-Bromohexane |
16.3 |
Cat. 2 |
Potassium hydroxide (5% aq.) |
40.1 |
Cat. 2 |
1-Methyl-3-phenyl-1-piperazine |
21.6 |
Cat. 2 |
Heptanal |
20.6 |
Cat. 2 |
In vitro Skin Irritation Assay: OECD 439 |
||
Proficiency Data (March 2014, non-GLP) performed at ICCR-Roßdorf GmbH Study |
||
Director: Dipl.-Ing. Andreas Heppenheimer |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- Under the conditions of the conducted test, the test substance did not possess irritating properties towards reconstructed human epidermis tissue in the EpiDerm™ model.
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