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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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 - 18 Dec 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
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:
- adopted in 2019
- Deviations:
- yes
- Remarks:
- demonstration of technical proficiency not included in the study report
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2-bis[(hexadecanoyloxy)methyl]propane-1,3-diyl dihexadecanoate
- Cas Number:
- 18641-58-2
- Molecular formula:
- C69H132O8
- IUPAC Name:
- 2,2-bis[(hexadecanoyloxy)methyl]propane-1,3-diyl dihexadecanoate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek Corporation (Ashland, Massuchusetts, USA)
- Source strain:
- other: EpiDerm™ Skin Model (EPI-200)
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The skin was moistened with 25 µL Milli-Q-water to ensure close contact of the test item to the tissue.
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-200) (MatTek Corporation, Ashland, Massachusetts, USA)
- Tissue batch number: 33783 Kit F
- Date of initiation of testing: 14 Dec 2020
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 min at room temperature and 60 min at 37 ± 1.0 °C (actual range: 35.9 – 37.3 °C)
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: After the exposure period, the tissues were washed with phosphate buffered saline to remove residual test item.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL, 300 µL/well
- Incubation time: 3 h at 37 ± 1.0 °C
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- 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 1.9 ± 0.157 (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 5.81 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: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Not applicable as the test item did not show colour changing or reducing capacity after incubation with MTT.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: Single experiment
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test item is considered to be corrosive to skin if the viability after 3 min exposure is less than 50% and the viability after 1 h exposure is less than 15%.
- The test item is considered to be non-corrosive to skin if the viability after 3 min exposure is greater than or equal to 50% and the viability after 1 h exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 25.14 - 44.96 mg
NEGATIVE CONTROL
- Amount applied: 50 µL
POSITIVE CONTROL
- Amount applied: 50 µL
- Concentration: 8.0 N - Duration of treatment / exposure:
- 3 and 60 min
- Number of replicates:
- Duplicates for each treatment and control group (3 and 60 min)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 3 min exposure
- Value:
- 94
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 60 min exposure
- Value:
- 102
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: The test item did not show reducing capacity after incubation with MTT
- Colour interference with MTT: The test substance did not change colour in the presence of MTT.
DEMONSTRATION OF TECHNICAL PROFICIENCY: Not included by the testing laboratory.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD 570 nm of the tissue replicates treated with the negative control was 1.780 ± 0.006 for the 3 min exposure and 1.732 ± 0.186 for the 1 h exposure and fell within the acceptance limits of OECD 431 (lower acceptance limit ≥ 0.8 and upper acceptance limit ≤ 2.8).
- Acceptance criteria met for positive control: The mean viability of the tissue replicates treated with the positive control was < 15% compared to the negative control (6.8% for 3 min exposure, 7.2% for 1 h exposure).
- Acceptance criteria met for variability between replicate measurements: The coefficient of variation (CV) in the range 20 – 100% viability between tissue replicates was ≤ 30% (values between 0.4 - 27%).
Any other information on results incl. tables
Table 1: Mean absorption in the in vitro skin corrosion test (values were corrected for background absorption)
Substance | 3-min application | 1-h application |
Mean ± SD (OD570) | Mean ± SD (OD570) | |
Negative control | 1.780 ± 0.006 | 1.732 ± 0.186 |
Test item | 1.668 ± 0.140 | 1.763 ± 0.238 |
Positive control | 0.120 ± 0.013 | 0.125 ± 0.027 |
SD = Standard deviation |
Table 2: Mean tissue viability in the in vitro skin corrosion test
Substance | 3-min application | 1-h application |
viability (percentage of control) | viability (percentage of control) | |
Negative control | 100 | 100 |
Test item | 94 |
102 |
Positive control | 6.8 | 7.2 |
Table 3: Historical control data#generated in the testing facility
|
Negative control |
Positive control |
||
3-min treatment (OD570) |
1-h treatment (OD570) |
3-min treatment (OD570) |
1-h treatment (OD570) |
|
Range |
1.375 - 2.226 |
1.317 - 2.269 |
0.080 - 0.671 |
0.032 - 0.319 |
Mean |
1.752 |
1.769 |
0.173 |
0.135 |
SD |
0.175 |
0.170 |
0.086 |
0.048 |
n |
122 |
122 |
122 |
122 |
SD = Standard deviation |
||||
n = Number of observations |
#: Data were collected over the period Nov 2017 – Nov 2020
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive according to Regulation (EC) No. 1272/2008.
- Conclusions:
- There is regulatory acceptance in the EU that a substance can be considered corrosive (Skin Corrosive Cat.1, 1A, 1B/C) based on a positive result in the human epidermis model test. Negative in vitro corrosivity responses are not conclusive with respect to non-classification or classification as irritant and shall therefore be subject to further evaluation.
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