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EC number: 860-695-9 | CAS number: 88247-41-0
- 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:
- 17 Mar 2021
- 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:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N-bis(2-ethylhexyl)formamide
- EC Number:
- 860-695-9
- Cas Number:
- 88247-41-0
- Molecular formula:
- C17H35NO
- IUPAC Name:
- N,N-bis(2-ethylhexyl)formamide
- 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: MatTek Corporation, Ashland, Massachusetts, USA
- Source strain:
- other: EpiDerm™ Skin Model (EPI-200)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-200) (MatTek Corporation, Ashland, MA, USA)
- Tissue batch number: 34727
- Delivery date: 16 Mar 2021
- Date of initiation of testing: 17 Mar 2021
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Room temperature (3-min exposure) and 37 °C (60 +/-1 min exposure)
- Temperature of post-treatment incubation: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: after the exposure, each tissue insert was rinsed twenty times with phosphate buffered saline (PBS)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL (300 µL/well)
- Incubation time: 180 ± 5 min at 37 °C
- Spectrophotometer: Multimode Microplate Reader (FLUOstar Omega, BMG Labtech)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA (performed by the supplier MatTek Corporation, Ashland, Massachusetts, USA)
- Viability: The quality of the EpiDerm™ tissue was assessed by an MTT cell viability test (4 h, n = 3). The determined OD (540 - 570 nm) was 1.573 ± 0.084 (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 6.68 h (acceptance criteria: 3.68 – 8.02 h).
- Contamination: The cells used to produce the EpiDerm™ tissue were screened for biological contamination (bacteria, yeast and other funghi). 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 60 min MTT incubation.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: Single experiment
PREDICTION MODEL / DECISION CRITERIA
- The test item is considered to be corrosive to skin if the viability after 3-minutes exposure is less than 50% and the viability after 1-hour exposure is less than 15%.
- The test item 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 applied: 50 µL
NEGATIVE CONTROL
- Amount applied: 50 µL
POSITIVE CONTROL
- Amount applied: 50 µL
- Concentration: 8.0 N - Duration of treatment / exposure:
- 3 min and 60 ± 1 min
- Number of replicates:
- Duplicates for each treatment and control group
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:
- 104.1
- 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:
- 91.3
- 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 1 h incubation with MTT
- Colour interference with MTT: The test substance did not change colour, when mixed with deionised water.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
The laboratory has demonstrated technical proficiency in the EpiDerm skin corrosion test by correct prediction of the corrosive potential of proficiency chemicals and by correct assignment of the chemicals into the sub-classes of corrosiveness as defined by the OECD guideline 431.
ACCEPTANCE OF RESULTS: (refer to Table 1 under "Any other information on results incl. tables")
- Acceptance criteria met for negative control: The mean OD 570 nm of the tissue replicates treated with the negative control was 1.766 for the 3 min exposure and 1.937 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 (1.6% for 1 hour 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 1.0 – 28.9%).
Any other information on results incl. tables
Table 1: Results of the skin corrosion test
Group | Tissue No. | 3 min exposure | 60 min exposure | ||||||||||
OD | Cell viability (%) | OD | Cell viability (%) | ||||||||||
individual | mean | mean ± SD | CV | individual | mean | mean | CV | ||||||
Distilled water | 1 | 1.64 | 1.687 | 1.766 | 95.5 | 100.0 ± 6.29 | 6.3 | 1.952 | 1.95 | 1.937 | 100.7 | 100.0 ± 0.99 | 1.00 |
1.662 | 1.948 | ||||||||||||
1.76 | 1.951 | ||||||||||||
2 | 1.848 | 1.844 | 104.4 | 1.904 | 1.923 | 99.3 | |||||||
1.899 | 1.898 | ||||||||||||
1.785 | 1.967 | ||||||||||||
8 N KOH | 1 | 0.101 | 0.099 | 0.125 | 5.6 | 7.1 ± 2.05 | 28.9 | 0.032 | 0.032 | 0.030 | 1.7 | 1.6 ± 0.21 | 13.3 |
0.099 | 0.032 | ||||||||||||
0.098 | 0.031 | ||||||||||||
2 | 0.149 | 0.150 | 8.5 | 0.029 | 0.028 | 1.4 | |||||||
0.154 | 0.028 | ||||||||||||
0.148 | 0.028 | ||||||||||||
Test item | 1 | 1.896 | 1.883 | 1.839 | 106.6 | 104.1 ± 3.54 | 3.4 | 1.755 | 1.746 | 1.769 | 90.1 | 91.3 ± 1.70 | 1.9 |
1.878 | 1.738 | ||||||||||||
1.876 | 1.746 | ||||||||||||
2 | 1.771 | 1.795 | 101.6 | 1.804 | 1.792 | 92.5 | |||||||
1.809 | 1.795 | ||||||||||||
1.805 | 1.777 | ||||||||||||
CV: coefficient of variation; OD: optical density; SD: standard deviation |
Table 2: Historical control data generated in the testing facility from May 2018 - Jan 2021 (n = 20)
|
OD |
|||
3-minute |
exposure |
60-minute exposure |
||
Negative control |
Positive control |
Negative control |
Positive control |
|
Mean |
1.908 |
0.134 |
1.887 |
0.051 |
SD |
0.145 |
0.039 |
0.149 |
0.017 |
OD: optical density; SD: standard deviation
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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