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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:
- 03 - 05 Nov 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
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 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40bis (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted in 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C6-18 (branched and linear) alkyl and hydrocarbons, C10-18, n-alkanes, branched alkanes, cycloalkanes, aromatics
- Molecular formula:
- not applicable due to UVCB substance
- IUPAC Name:
- Fatty acids, C6-18 (branched and linear) alkyl and hydrocarbons, C10-18, n-alkanes, branched alkanes, cycloalkanes, aromatics
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm™ Human Skin Model
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Reconstructed Human Epidermis
- Tissue batch number: 34102
- Delivery date: 03 November 2020
- Date of initiation of testing: 03 November 2020
- Assay medium lot number: 102920LHB
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C, 5% CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing procedure: Rinsing was achieved by filling and emptying each tissue insert under a constant soft stream of Dulbecco’s Phosphate Buffered Saline (DPBS) (without Ca++ Mg++) for approximately 40 seconds. Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h (37 °C, 5% CO2)
- Spectrophotometer: Labtech LT-4500 microplate 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 1.704 ± 0.078 (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 5.75 h (acceptance criteria: 4.77-8.72 h).
- Morphology: No histological examination was reported.
- 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.
- Reproducibility: No information if the results of the positive and negative controls showed reproducibility over time was reported.
NUMBER OF REPLICATE TISSUES: duplicates
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- The test item did not reduce MTT.
NUMBER OF INDEPENDENT EXPERIMENTS TO DERIVE FINAL PREDICTION: single experiment
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 min exposure is less than 50%, or if the viability after 3 min exposure is greater than or equal to 50% and the viability after 1 h exposure is less than 15%.
- The test substance 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: 50 μL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
- Lot/batch no.: 18L10BA1A
- Purity: 100%
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
- Concentration: 8N
- Lot/batch no.: H3410 - 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
- Run / experiment:
- 3 min exposure
- Value:
- 91.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min exposure
- Value:
- 85.7
- 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.
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 1.862 and 2.233).
- 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 (3.7%).
- Acceptance criteria met for variability between replicate measurements: The coefficient of variation (CV) in the range 20 – 100% viability between tissue replicates is ≤ 30% (values between 1.1% and 12.8%)
Any other information on results incl. tables
Table 2: Results (summary)
Exposure Period |
Percentage Viability |
||
Negative Control |
Positive Control |
Test Item |
|
3 minute |
100* |
3.9 |
91.7 |
60 minute |
100* |
3.7 |
85.7 |
*: The mean viability of the negative control tissues is set at 100%
Table 3: Detailed results
Tissue |
Exposure Period |
MeanOD570of individual tissues |
Mean OD570of duplicate tissues |
Standard Deviation |
Coefficient of Variation |
Relative Mean Viability (%) |
Negative Control |
3 Minutes |
2.233 |
2.048 |
0.262 |
12.8 |
100* |
1.862 |
||||||
60 Minutes |
2.006 |
2.022 |
0.023 |
1.1 |
||
2.038 |
||||||
Positive Control |
3 Minutes |
0.095 |
0.080 |
0.022 |
na |
3.9 |
0.064 |
||||||
60 Minutes |
0.096 |
0.076 |
0.029 |
na |
3.7 |
|
0.055 |
||||||
Test Item |
3 Minutes |
1.953 |
1.879 |
0.105 |
5.6 |
91.7 |
1.805 |
||||||
60 Minutes |
1.755 |
1.733 |
0.032 |
1.8 |
85.7 |
|
1.710 |
OD: Optical density
*: The mean percentage viability of the negative control tissue is set at 100%
na: Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- 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 Reconstructed human epidermis test method (in vitro skin corrosion). A negative in vitro corrosivity response is not conclusive with respect to non-classification or classification as a skin irritant and therefore requires further evaluation and/or data generation.
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