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EC number: 268-761-3 | CAS number: 68139-30-0
- 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:
- 02 May, 2018 - 04 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- yes
- Remarks:
- An assessment found the test item was able to directly reduce MTT and an additional procedure using freeze-killed tissues was performed. However, the results obtained showed that no interference due to direct reduction of MTT occurred.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts
- EC Number:
- 268-761-3
- EC Name:
- 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts
- Cas Number:
- 68139-30-0
- Molecular formula:
- C9H19N2O5S(CnH(2n+1)), (n=7,9,11,13,15,17)
- IUPAC Name:
- 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: DSP-001.
- Expiration date of the lot/batch: 15 August 2018.
- Purity test date: No data.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item (solid) was pressed flat and appropriate sized discs were cut out. The application of the discs is an acceptable method in accordance with the MatTek SOP MK-24-007-0024 of the validated and regulatory accepted EpiDerm SCT.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Reconstructed Human Epidermis Model Kit.
- Supplier: MatTek.
- Tissue batch number(s): 28602.
- Delivery date: 01 May 2018.
- Date of initiation of testing: 02 May 2018.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C.
- Temperature of post-treatment incubation (if applicable): Room temperature.
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps:
- Observable damage in the tissue due to washing:
- Modifications to validated SOP:
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL.
- Incubation time: 3 hours.
- Spectrophotometer: Labtech LT-4500 microplate reader.
- Wavelength: 570 nm.
- Linear OD range of spectrophotometer: 0-4 OD.
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: ET-50 fall within the range of the 1996 EpiDerm database of 4.77 – 8.72 hours.
- Barrier function: Lipid precursors used to enhance epidermal barrier formation.
- Morphology: Good retention of epidermal morphology for up to 3 weeks.
- Contamination: All tissues are visually inspected and if physical imperfections are noted, tissues are rejected for shipment.
- Reproducibility: Tissues may be stored at 4°C for up to 6 days prior to use, although best reproducibility obtained if used on same day.
NUMBER OF REPLICATE TISSUES: 2.
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues : The test item was shown to directly reduce MTT in the direct MTT reduction test, therefore the determination of skin corrosion potential was performed in parallel on viable and freeze-killed tissues.
- Procedure used to prepare the killed tissues: Freeze-killed tissues were prepared prior to the study by placing untreated EPIDERM 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.
- Number of replicates: 2.
- Method of calculation used: Relative mean viability (%) - (mean OD570 of test item / mean OD570 of negative control) x 100.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
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 negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.0931 g.
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL.
- Concentration (if solution): 100%.
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL.
- Concentration (if solution): 100%. - Duration of treatment / exposure:
- 3 and 60 minutes.
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute exposure
- Value:
- 90
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Remarks:
- Percentage viability 100%
- Positive controls validity:
- valid
- Remarks:
- Percentage viability 3.3%
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minute exposure
- Value:
- 80.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Remarks:
- Percentage viability 100%
- Positive controls validity:
- valid
- Remarks:
- Percentage viability 2.9%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None observed.
- Direct-MTT reduction: The results obtained from the freeze-killed tissues showed that no interference due to direct reduction of MTT occurred. It was therefore considered unnecessary to use the results for quantitative correction of results or for reporting purposes.
- Colour interference with MTT: 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: The mean OD570 for the negative control treated tissues was 1.854 for the 3-Minute exposure period and 1.927 for the 60-Minute exposure period. The negative control acceptance criteria were therefore satisfied.
- Acceptance criteria met for positive control: The relative mean tissue viability for the positive control treated tissues was 2.9% relative to the negative control following the 60-Minute exposure period. The positive control acceptance criterion was therefore satisfied.
- Acceptance criteria met for variability between replicate measurements: In the range 20 to 100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be non-corrosive to the skin.
- Executive summary:
1-Propanaminium, N-(3-aminopropyl)-2-hydroxy- N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts was tested according to OECD Test Guideline 431 to predict its potential for skin corrosivity by cytotoxicity in the EpiDerm™ tissue. Following a 60 minute exposure period to the test item, mean tissue viability was 80.8%, well above the <15% threshold for classification as corrosive to the skin.
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