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Diss Factsheets
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EC number: 219-354-4 | CAS number: 2424-01-3
- 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:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- 29 July, 2016
- Deviations:
- no
- Remarks:
- No deviations occurred that impacted the study integrity or interpretation of the results.
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-methyldiallylamine
- EC Number:
- 219-354-4
- EC Name:
- N-methyldiallylamine
- Cas Number:
- 2424-01-3
- Molecular formula:
- C7H13N
- IUPAC Name:
- methylbis(prop-2-en-1-yl)amine
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch 20160912
- Expiration date of the lot/batch: 01 August 2018
- Purity test date: 25 July 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stable until 01 August 2018
- Stability under test conditions: Stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was applied neat.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Normal, human-derived epidermal keratinocytes that have been cultured to form a multilayered, highly differentiated model of the human epidermis.
- Cell source:
- other: MatTek Keratinocyte strain: 4F1188
- Source strain:
- other: Human
- Details on animal used as source of test system:
- SOURCE ANIMAL
- Source: Human: MatTek Keratinocyte strain: 4F1188 - Justification for test system used:
- Test system recommended by OECD Guideline 431.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 C
- Temperature of post-treatment incubation (if applicable): 37 C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: No data
- Observable damage in the tissue due to washing: No data
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: TECAN Infinite M200 Pro Plate Reader
- Wavelength: 570 nm
- Filter: No data
- Filter bandwidth: No data
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3
PREDICTION MODEL / DECISION CRITERIA
The in vitro skin corrosion test is considered acceptable if it meets the following criteria:
a) The absolute mean OD570 of the two tissues of the negative control should reasonably be
within the laboratory historical control data range.
b) The mean relative tissue viability following 1-hour exposure to the positive control
should be <15 %.
c) In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue
replicates should be less than or equal to 30%.
d) The %NSC should be less than or equal to 30% relative to the negative control OD.
e) The non-specific MTT reduction should be less than or equal to 30% relative to the negative control OD.
A test item is considered corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after 3-minute treatment compared to the
negative control tissues is decreased below 50%.
b) In addition, a test item considered non-corrosive (viability 50%) after the 3-minute
treatment is considered corrosive if the relative tissue viability after 1-hour treatment with
the test item is decreased below 15%.
A test item is considered non corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after the 3-minute treatment compared to the
negative control tissues is not decreased below 50%.
b) In addition, the relative tissue viability after the 1-hour treatment is not decreased below
15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 uL
VEHICLE: None
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): Milli-Q water: 50 uL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): Potassium hydroxide: 50 uL
- Concentration (if solution): 8N - Duration of treatment / exposure:
- 3 minutes, 1 hour
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 4
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute exposure
- Value:
- ca. 90
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour exposure
- Value:
- ca. 6.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Tissue viability after 1-hour exposure is less than 15%, indicating that the test article is corrosive.
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No data
- Direct-MTT reduction: The test article does not directly reduce MTT
- Colour interference with MTT: None
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Based on the results of the study, the test article is corrosive to the skin.
- Executive summary:
The skin corrosion potential of MTDID 49220 was evaluated through topical application on a reconstructed human epidermal model for 3 minutes and 1 hour exposures. The study was conducted according to OECD 431 (2017) and was conducted in compliance with OECD GLP. Batch 20160912 of MTDID 49220 was a clear yellow liquid. MTDID 49220 was applied undiluted (50 μl) directly on top of the skin tissue. Negative (Milli-Q water) and positive (8N Potassium hydroxide) controls were tested concurrently. The relative mean tissue viability for test article-treated tissues obtained after 3-minute and 1-hour treatments with MTDID 49220 compared to the negative control tissues was 90% and 6.3%, respectively. Based on the results of the study, the test article is corrosive to the skin.
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