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EC number: 283-393-3 | CAS number: 84608-82-2
- 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:
- 24 - 27 July 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted in 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU method B.40 BIS. (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted in 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
Test material
- Reference substance name:
- 2-hydroxy-3-(oleoyloxy)propyl 5-oxo-L-prolinate
- EC Number:
- 283-393-3
- EC Name:
- 2-hydroxy-3-(oleoyloxy)propyl 5-oxo-L-prolinate
- Cas Number:
- 84608-82-2
- Molecular formula:
- C26H45NO6
- IUPAC Name:
- 2-hydroxy-3-(oleoyloxy)propyl 5-oxo-L-prolinate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Source strain:
- other: Keratinocyte strain: 00267
- Justification for test system used:
- The EpiDerm™ tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, 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.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™, EPI-200-SCT
- Tissue batch number(s): 25832
- Delivery date: 25 July 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: The inserts were thoroughly rinsed with DPBS, blotted with sterile cellulose tissue and set into the respective holding plate, using the wells containing assay medium.
- Observable damage in the tissue due to washing: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: Anthos Reader 2010 Flexi, Anthos Microsysteme GmbH
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 1.466 ± 0.03 (acceptance criteria: OD (540 - 570 nm) = 1.0 - 3.0)
- Barrier function: 6.06 h (acceptance criteria: ET 50 = 4.77 - 8.72 h)
- Morphology: viable basal cell layer, intermediate spinous and granular layers and a functional stratum corneum
- Contamination: no
- Reproducibility: yes
NUMBER OF REPLICATE TISSUES: 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
And if criteria was met for corrosiveness and if the viability after 3 minutes exposure was less than 25%, then the substance is classified as Skin Corrosive Subcategory 1A, while a viability after 3 minutes exposure greater or equal to 25% would lead to a classification as Skin Corrosive Subcategory 1B or 1C
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 μL (a nylon mesh was added in order to ensure sufficient contact with the tissue surface (tissue size is not reported)
- Concentration: undiluted
NEGATIVE CONTROL
- Amount(s) applied: 50 μL
- Concentration: undiluted
POSITIVE CONTROL
- Amount(s) applied: 50 μL
- Concentration: 8M - Duration of treatment / exposure:
- 3 min / 60 min
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value of 2 replicates, test substance, 3 min exposure
- Value:
- 96.9
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value of 2 replicates, test substance, 60 min exposure
- Value:
- 91.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value of 2 replicates, positive control, 3 min exposure
- Value:
- 27.9
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value of 2 replicates, positive control, 60 min exposure
- Value:
- 8.1
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: tested, but no reduction was observed
- Colour interference with MTT: tested, but no interference was observed
DEMONSTRATION OF TECHNICAL PROFICIENCY: not in the report
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes (OD = 1.7 (3 min and 1 h) ≥ 0.8 and ≤ 2.8 and within historical control range (3 min: 1.197 - 3.077 and 60 min: 1.377 - 2.571))
- Acceptance criteria met for positive control: yes (viabilty at 3 min = 27.9% < 50% and at 1 h = 8.1% < 15% and within historical control range (3 min: 9.6 - 57.3% and 60 min: 4.1 - 24.2%))
- Acceptance criteria met for variability between replicate measurements: yes, regarding to OECD TG 431 criteria (In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue replicates should be ≤ 30%
Any other information on results incl. tables
Table 1: MTT assay after 3 min exposure
Negative control |
Positive control |
Test item |
||||
Tissue sample |
1 |
2 |
1 |
2 |
1 |
2 |
OD570 |
1.681 |
1.749 |
0.503 |
0.522 |
1.674 |
1.661 |
1.719 |
1.729 |
0.498 |
0.518 |
1.676 |
1.663 |
|
1.729 |
1.728 |
0.493 |
0.520 |
1.671 |
1.677 |
|
OD570(mean-blank) |
1.671 |
1.697 |
0.459 |
0.481 |
1.635 |
1.628 |
OD570(mean values) |
1.684 |
0.470 |
1.632 |
|||
rel. viability (%) |
100.0 |
27.9 |
96.9 |
|||
rel. SD |
1.1 |
3.3 |
0.3 |
Table 2: MTT assays after 60 min exposure
Negative control |
Positive control |
Test item |
||||
Tissue sample |
1 |
2 |
1 |
2 |
1 |
2 |
OD570 |
1.710 |
1.721 |
0.170 |
0.167 |
1.532 |
1.584 |
1.715 |
1.675 |
0.171 |
0.180 |
1.542 |
1.600 |
|
1.709 |
1.702 |
0.172 |
0.181 |
1.537 |
1.614 |
|
OD570(mean-blank) |
1.673 |
1.661 |
0.132 |
0.137 |
1.498 |
1.561 |
OD570(mean values) |
1.667 |
0.135 |
1.530 |
|||
rel. viability (%) |
100.0 |
8.1 |
91.8 |
|||
rel. SD |
0.5 |
2.6 |
2.9 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive (Skin Irrit. 2 or not classified according to Regulation (EC) No 1272/2008)
- Conclusions:
- Under the conditions of the test, the test substance was shown to have no corrosive potential towards reconstructed human epidermis tissue in the EpiDerm™ model. The result does not allow for the non-classification or classification as irritant of the test substance and therefore further evaluation and/or data generation is required.
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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