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EC number: 255-615-9 | CAS number: 41999-70-6
- 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:
- 2018-05-09 to 2018-05-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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:
- 29 July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Method B.40 bis of Commission Regulation (EC) No 440/2008
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-[(3-aminopropyl)methylamino]ethanol
- EC Number:
- 255-615-9
- EC Name:
- 2-[(3-aminopropyl)methylamino]ethanol
- Cas Number:
- 41999-70-6
- Molecular formula:
- C6H16N2O
- IUPAC Name:
- 2-[(3-aminopropyl)(methyl)amino]ethan-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch: PFW110370
Purity: 99.10%
Storage Conditions: Room temperature in the dark
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Cell type: epithelial, derived from human skin, and formed into a stratified, cornified epithelium
- Source strain:
- not specified
- Details on animal used as source of test system:
- not applicable
- Justification for test system used:
- This model incorporates several features, which make it advantageous in the study of potential dermal corrosivity.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Reconstructed Human Epidermis
- Tissue batch number(s): 28607
- Production date: not specified
- Shipping date: not specified
- Delivery date: 08 May 2018
- Date of initiation of testing: 09 May 2018
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
- Volume and number of washing steps: Rinsing was achieved by filling and emptying each tissue under a constant soft stream of Dulbecco’s Phosphate Buffered Saline (DPBS) (without Ca++ Mg++) for approximately 40 seconds
- Observable damage in the tissue due to washing: n/a
- Modifications to validated SOP: n/a
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL solution
- Incubation time: 3 Minute and 60 Minute exposure periods
- Spectrophotometer: Labtech LT 4500 microplate reader
- Wavelength: 570 nm (OD570)
NUMBER OF REPLICATE TISSUES: duplicates
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues : Freeze-killed
- Procedure used to prepare the killed tissues (if applicable): Placing untreated EPIDERMTM tissues in an empty 12 well plate and storing in a freezer (-14 to -30 °C) for a minimum of 24 hours. Before use each tissue was thawed by placing in 0.9 mL of assay medium for approximately 1 hour at room temperature.
- No. of replicates per exposure: Two
DECISION CRITERIA
- 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 negative control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL of the test item
VEHICLE : no vehicle used
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL of sterile distilled water (negative control)
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL of 8.0 N Potassium Hydroxide (positive control) - Duration of treatment / exposure:
- 3 Minute exposure and 60 Minute exposure
- Duration of post-treatment incubation (if applicable):
- n/a
- Number of replicates:
- Two at each timepoint
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test - 60 minute exposure
- Value:
- 9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test - 3 minute exposure
- Value:
- 60.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: not observed
- Direct-MTT reduction: The MTT solution containing the test item turned purple, indicating that the test item was able to directly reduce MTT. An additional procedure using freeze killed tissues was performed to determine the magnitude of interference due to direct reduction of MTT. However, the results obtained showed that the magnitude of interference was negligible. It was therefore considered unnecessary to use the results of the freeze-killed tissues for quantitative correction of results or reporting purposes.
- Colour interference with MTT: By visual assessment, the solution containing the test item did not become colored. This was taken to indicate the test item did not have the potential to cause color interference.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, the mean OD570 for the negative control treated tissues was 1.755 for the 3-Minute exposure period and 1.919 for the 60-Minute exposure period.
- Acceptance criteria met for positive control: yes, the relative mean tissue viability for the positive control treated tissues was 2.8% relative to the negative control following the 60-Minute exposure period.
- Acceptance criteria met for variability between replicate measurements: yes, the viability Coefficient of Variation between the two tissue replicates were 1.6% (3 minutes); 0.9% (60 minutes) for the negative control and 16.7% (3 minutes) for the test item. The remainder of the Coefficient of Variations were not applicable because the viabilities were < 20%.
Any other information on results incl. tables
Mean OD570Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Tissue |
Exposure Period |
MeanOD570of individual tissues |
Mean OD570of duplicate tissues |
Standard Deviation |
Coefficient of Variation |
Relative Mean Viability (%) |
Negative Control |
3 Minutes |
1.735 |
1.755 |
0.028 |
1.6 |
100* |
1.774 |
||||||
60 Minutes |
1.906 |
1.919 |
0.018 |
0.9 |
||
1.931 |
||||||
Positive Control |
3 Minutes |
0.064 |
0.060 |
0.006 |
na |
3.4 |
0.055 |
||||||
60 Minutes |
0.056 |
0.054 |
0.003 |
na |
2.8 |
|
0.052 |
||||||
Test Item |
3 Minutes |
1.190 |
1.065 |
0.177 |
16.7 |
60.7 |
0.939 |
||||||
60 Minutes |
0.160 |
0.172 |
0.017 |
na |
9.0 |
|
0.184 |
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:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- The test item was considered to be corrosive. According to UN GHS, it is classified as H314 (Combination of sub-categories 1B and 1C).
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