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EC number: 219-588-7 | CAS number: 2469-55-8
- 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:
- key study
- Study period:
- 23 November 2015 to 14 December 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine
- EC Number:
- 219-588-7
- EC Name:
- 3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine
- Cas Number:
- 2469-55-8
- Molecular formula:
- C10H28N2OSi2
- IUPAC Name:
- 3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine
- Reference substance name:
- 3,3’-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine
- IUPAC Name:
- 3,3’-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine
- Test material form:
- other: liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: Unstable after repeated contact to air.
- Solubility and stability of the test substance in the solvent/vehicle: The test item was applied undiluted.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was applied undiluted. No treatment of test material prior to testing was performed.
- Preliminary purification step (if any): None
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
FORM AS APPLIED IN THE TEST (if different from that of starting material): not applicable
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Source strain:
- other: not applicable
- Details on animal used as source of test system:
- Not applicable
- Justification for test system used:
- EpiDermTM reconstructed human epidermis model consists of human keratynocytes and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human, i.e. the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM Reconstructed Human Epidermis.
- Tissue batch number(s): 23306
- Production date: not specified
- Shipping date: not specified
- Delivery date: not specified
- Date of initiation of testing: 23 November 2015
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: After dosing, all tissues and plates were tranferred to the incubator for 35 min at 37°C. After 35 min, all plates were removed from the incubator and placed under the sterile flow until the 60 +/- 1 min incubation time of the first dosed tissue were over.
- Temperature of post-treatment incubation (if applicable): at 37°C for 24 +/- 2 hours.
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: After the 60 minutes incubation the tissues were washed intensively with DPBS.
- Observable damage in the tissue due to washing: None reported
- Modifications to validated SOP: not applicable
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 300 µL
- Incubation time: 3 h at 37°C
- Spectrophotometer: plate specrophotometer
- Wavelength: OD measured at 570 nm
- Filter: not specified
- Filter bandwidth: not specified
- Linear OD range of spectrophotometer: without reference wavelength
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 1.179+/-0.156, acceptance criteria OD (540-570 nm) [1.0 - 3.0]
- Barrier function: 6.26, acceptance criteria ET-50 [4.77-8.72 hrs]
- Morphology: not specified
- Contamination: No contamination detected
- Reproducibility: not specified
NUMBER OF REPLICATE TISSUES: Triplicate
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues: Since the test item showed clear irritant potential, no correction was performed.
- Procedure used to prepare the killed tissues (if applicable): not applicable
- N. of replicates : not applicable
- Method of calculation used: not applicable
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: One
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the viability after 60 minutes exposure is less than 50%
- The test substance is considered to be non-irritant to skin if the viability after 60 minutes exposure is greater than or equal to 50%
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: not applicable - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Concentration (if solution): 30 µL
NEGATIVE CONTROL
- Concentration (if solution): 30 µL DPBS
POSITIVE CONTROL
- Concentration (if solution): 30 µL 5% SDS solution - Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- Triplicate
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min treatment and 42 hours post-incubation
- Value:
- < 50
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None damage reported
- Direct-MTT reduction: The mixture of 30 µL test item per 1 mL MTT medium showed reduction of MTT compared to the solvent. The mixture turned blue/purple.
- Colour interference with MTT: The mixture of 30µL of the test item per 300 µL aqua dest. showed no colouring detectable by unaided eye assessment.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
- Mean absolute OD 570nm NC: Value 1.931, cut off 0.8 < NC < 2.8
- Relative Viability [%] PC: value 4.7, cut off =< 20%
- SD Viability [%]: value 0.6-14.8, cut off < 18%
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
- Range of historical values if different from the ones specified in the test guideline: not applicable
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In the in vitro skin irritation study for 3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine using EpiDermTM, reported mean relative tissue viability (% negative control) of =< 50 % (5.3%) after 60 min treatment and 42 hours post incubation.
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