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Diss Factsheets
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EC number: 947-894-7 | 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 26 February 2018 - 07 May 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015
- Deviations:
- yes
- Remarks:
- Please refer to the "Principles of method if other than guideline" field.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2017
- Deviations:
- yes
- Remarks:
- Please refer to the "Principles of method if other than guideline" field.
- Principles of method if other than guideline:
- The pre-incubation period was 16 h (guideline requirement: 18-24 h) and the post-incubation period was 40 h 24 min (guideline requirement: 42 h). The incubation periods used are in accordance with the validated MatTek protocol. This deviation does not affect the validity or quality of the result. The test item is considered to be classified as irritant or corrosive (UN GHS Cat. 2 or Cat 1). A longer pre- and post-incubation period is expect to reveal the same result.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (2-hydroxy-1,1-dimethylethyl)ammonium chloride
- EC Number:
- 221-713-5
- EC Name:
- (2-hydroxy-1,1-dimethylethyl)ammonium chloride
- Cas Number:
- 3207-12-3
- Molecular formula:
- C4H11NO.ClH
- IUPAC Name:
- 1-hydroxy-2-methylpropan-2-aminium chloride
- Test material form:
- liquid
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Reconstructed Human Epidermal Model - EpiDerm™ (EPI-200-SIT)
- Tissue batch number: 25891
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
- Temperature of post-treatment incubation: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: 15 times filling and emptying the tissue inserts with DPBS, 3 times shaking with approx. 50 mL DPBS
- Observable damage in the tissue due to washing: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: plate reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The tissue viability was within the acceptable range.
- Barrier function: The barrier function was within the acceptable range.
- Contamination: No contaminations were determined.
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive or irritant to skin if the viability after exposure and post-exposure is less than or equal to 50 %.
- The test substance is considered to be non-corrosive and non-irritant to skin if the viability after exposure and post-exposure is more than 50 %. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 30 µL
NEGATIVE CONTROL
- Amount applied: 30 µL
POSITIVE CONTROL
- Amount applied: 30 µL
- Concentration: 5% SDS - Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- 22 h 58 min
- Number of replicates:
- 3 replicates per test item, 3 replicates negative controls and 3 replicates positive controls
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean
- Run / experiment:
- 1-3
- Value:
- 17.2
- 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: none
- Direct-MTT reduction: no
- Colour interference with MTT: no
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
Any other information on results incl. tables
Table 1: Summary of optical desity (OD) and Viability (%)
Treatment |
|
OD |
Viability (%) |
Negative Control (DPBS) |
Mean |
1.879 |
100 |
±SD |
0.075 |
4.01 |
|
n |
3 |
3 |
|
Positive Control (5% Sodium Dodecyl Sulphate) |
Mean |
0.066 |
3.5 |
±SD |
0.003 |
0.15 |
|
n |
3 |
3 |
|
Test Item |
Mean |
0.322 |
17.2 |
±SD |
0.028 |
1.51 |
|
n |
3 |
3 |
n = No. of tissues; SD = Standard Deviation
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1 (corrosive) or Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test item is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1), as the mean percentage tissue viability was less than 50% of the negative control.
- Executive summary:
The objective of this study was to evaluate the skin irritation potential of the test item using Reconstructed Human Epidermal Model-EpiDerm™ (EPI-200-SIT) according to OECD Guideline for the testing of chemicals No. 439, “In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method”, adopted on 28thJuly 2015. The test item did not develop any colour when dissolved in distilled water or isopropanol and was considered not to reduce MTT as no purple colour was developed when mixed and incubated with MTT solution. After receipt of the tissues, visual inspection was performed. As there were no tissue defects, air bubble or excess moisture observed, all the tissue inserts were used for the study.Tissue inserts were transferred to upper row of 6 well plates prefilled with 0.9 mL of assay medium and incubated in CO2 incubator for 55 minutes. After 55 minutes of incubation, tissues were transferred to lower row of 6 well plates prefilled with 0.9 mL of assay medium and incubated in CO2 incubator for 15 hours. After the incubation period, the tissues were topically exposed to 30 µL of DPBS (negative control: NC), 30 µL of 5% aq. SDS solution (positive control: PC) or 30 µL of the test item. All treatments were maintained in triplicates. After 60 minutes of exposure with negative control, positive control or test item, the tissues were washed using DPBS. Later, the tissue inserts were blotted and transferred to fresh medium and incubated in CO2 incubator for 22 hours and 58 minutes. After incubation period (Day 1), tissue inserts were shifted from upper wells to lower wells of 6 -well plates prefilled with 0.9 mL of assay medium. After the media change, tissues were incubated for an additional 17 hours and 26 minutes in CO2 incubator. After post-incubation period, the bottom of the tissue inserts was blotted and transferred into an MTT solution and incubated for 3 hours. The resultant purple-blue formazan salt, formed mainly by mitochondrial metabolism, was extracted for 2 hours using extraction solvent (MTT-EXT-100). The optical density of the extracted formazan was measured in a 96-well plate spectrophotometer at 570 nm. Viability of tissues was calculated by entering OD values in the spread sheet provided by MatTek.
Percentage viability of negative control, positive control and test item was 100±4.01 %, 3.5±0.15 % and 17.2±1.51 % respectively. The percentage of viability in the positive control (PC) was less than 50%, which shows the irritating/corrosive potential of the positive control and the suitability of the test method. As the percentage viability of the test item was less than 50% of the negative control, the test item is considered to be irritant or corrosive to skin (UN GHS Category 2 or Category 1).
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