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Diss Factsheets
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EC number: 220-284-1 | CAS number: 2700-30-3
- 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:
- From 30 Mar 2021 to 22 Apr 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N-bis(1-methylethyl)formamide
- EC Number:
- 220-284-1
- EC Name:
- N,N-bis(1-methylethyl)formamide
- Cas Number:
- 2700-30-3
- Molecular formula:
- C7H15NO
- IUPAC Name:
- N,N-Diisopropylformamide
Constituent 1
- Specific details on test material used for the study:
- Batch number: M-O303190723301F
Purity: 99.68%
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Justification for test system used:
- The EpiDerm™ Skin Model closely parallels human skin, and is recommended by test guidelines.
- Vehicle:
- other: Tissue Culture Water (TCH2O)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek EpiDerm™ Skin Model (EPI-200)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37±1°C
- Temperature of post-treatment incubation (if applicable):
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 100 μl of the test article were mixed with 1 ml of MTT solution (1 mg/ml thiazolyl blue tetrazolium bromide diluted in Dulbecco's Modified Eagle's Medium (DMEM)).
- Incubation time: The tissues were then returned to the incubator for an MTT incubation period
of 3 hours ± 10 minutes.
- Spectrophotometer: microplate reader (μQuant Plate Reader, BioTek® Instruments, Winooski, VT).
- Wavelength: 540 nm
NUMBER OF REPLICATE TISSUES: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- 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%.
- 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 vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- 50 μl of the test article were applied to the top of each EpiDerm™ tissue.
- Duration of treatment / exposure:
- The test article remained in contact with the EpiDerm™ tissue for 3 minutes at room temperature and 60 minutes at 37±1°C, 5±1% CO2.
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes exposure
- Value:
- 88.6
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes exposure
- Value:
- 10
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The mean OD of the negative control tissues was 1.686 at 3 minutes and 1.611 at 60 minutes, which met the acceptance criterion (OD ≥ 0.8).
The mean relative tissue viability of the 60-minute positive control was 2.5%, which met the acceptance criterion (<15%).
Viability differences between the two identically treated tissues in all samples and controls at 3 minutes were 2.5% to 4.1%. Viability differences between the two identically treated tissues at 60 minutes were 0.2% to 1.3%. Inter-tissue viability differences at both time points met the acceptance criterion (≤30%).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The test substance is skin corrosive.
- Executive summary:
The MatTek EpiDerm™ Skin Corrosivity Test is performed on the substance. The mean viability at 3 minutes and 60 minutes are 88.6% and 10%. The test substance is skin corrosive.
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