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EC number: 812-745-6 | CAS number: 205041-15-2
- 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:
- weight of evidence
- Study period:
- 2020-03-09 to 2020-04-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
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:
- adopted 18th June 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (prop-2-en-1-yl)({3-[(prop-2-en-1-yl)amino]propyl})amine dihydrochloride
- EC Number:
- 812-745-6
- Cas Number:
- 205041-15-2
- Molecular formula:
- C9 H20 Cl2 N2
- IUPAC Name:
- (prop-2-en-1-yl)({3-[(prop-2-en-1-yl)amino]propyl})amine dihydrochloride
- Test material form:
- solid
- Details on test material:
- - CAS: 205041-15-2
- Batch: LWDDP00072
- Colour: white
- Purity (GC): 100%
- Expiry date: 2020-08-11
- Storage conditions: room temperature
- Stability: stable under recommended storage conditions
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- 25 mg of the test item were applied directly atop the EpiDerm^TM tissue using an application spoon avoiding compression of the test item. To ensure good contact with the skin the test item was moistened with 25 μL H2O. The volume of H2O was increased, and the test item was spread to match size of the tissue.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The EpiDerm^TM Skin Model is a well-established organotypic, three-dimensional model of the human epidermis and is used for in vitro experiments since many years. It is known for its similarity to human skin.
- Vehicle:
- water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm(TM), EPI-200 (MatTek)
- Tissue batch number(s): Lot No. 30851 A
EpiDerm Kit:
The EpiDerm tissues were provided as kits (MatTek), consisting of the following components relevant for this study:
1x sealed plate containing e.g. 24 reconstructed epidermis units (area: 0.63 cm²); each reconstructed epidermis is attached to a cell culture insert and maintained on nutritive agar for transport (Lot: 30851 A)
2x 24-well plates
4x 6-well plates
1x bottle of assay medium (DMEM-based medium; Lot: 030520MJC)
1x bottle of DPBS Rinse Solution (Lot: 112719ISE)
25 pieces Nylon Mesh circles (8 mm diameter, 200 µm pore)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: After 3 min or 60 min of application, the inserts were removed from the 6-well plate with forceps. Using a wash bottle, the tissue was gently rinsed about 20 times with PBS (phosphate buffered saline) to remove any residual test item.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT stock solution (5 mg/mL) was diluted 1 + 4 with DMEM-based medium (final concentration 1 mg/mL)
- Incubation time: 3 h
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 2
PREDICTION MODEL / DECISION CRITERIA: For more details see Table 1 in section "Any other information on materials and methods incl. tables"
See Table 1 in box "Any other information on materials and methods incl. tables". - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 mg + 50 μL H2O (the volume was increased to spread the test item on the surface of the tissue)
VEHICLE : water
- Amount(s) applied: 50 µl
NEGATIVE CONTROL : distilled water
- Amount(s) applied: 50 μL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL 8 N KOH
- Concentration (if solution): 8 N - Duration of treatment / exposure:
- 3 min and 60 min
- Duration of post-treatment incubation (if applicable):
- 3 h
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure period, mean of replicates
- Value:
- 107.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: non-corrosive
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min exposure period, mean of replicates
- Value:
- 68.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: non-corrosive
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: The mixture of 25 mg test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT is determined to be 0%.
- Colour interference with MTT: The mixture of 25 mg test item per 300 μL Aqua dest. and 300 µL isopropanol showed no colouring as compared to the solvent. Therefore NSC is determined to be 0%.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative & positive control: The controls confirmed the validity of the study. The mean OD570nm of the two negative control tissues was ≥ 0.8 and ≤ 2.8 for each exposure period (1.687, 1.823). The mean relative tissue viability (% negative control) of the positive control was < 15% (3.4%) after 60 min treatment. The coefficient of variation (CV) (in the range of 20 – 100% viability) of replicate tissues of all dose groups was ≤ 30% (0.3% - 6.4%).
For details and raw data results please refer to Tables 2 and 3 in section "Any other information on results incl. tables".
Any other information on results incl. tables
Table 2: Results of 3 min Experiment
Name |
Negative Control |
Positive Control |
Test Item |
|||
Replicate Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
1.673 |
1.716 |
0.120 |
0.109 |
1.908 |
1.755 |
1.654 |
1.683 |
0.120 |
0.108 |
1.872 |
1.714 |
|
1.725 |
1.674 |
0.120 |
0.110 |
1.882 |
1.719 |
|
Mean Absolute OD570 |
1.687*** |
0.114 |
1.808 |
|||
OD570- Blank Corrected |
1.623 |
1.666 |
0.070 |
0.059 |
1.858 |
1.705 |
1.604 |
1.633 |
0.070 |
0.058 |
1.822 |
1.664 |
|
1.675 |
1.624 |
0.070 |
0.060 |
1.832 |
1.669 |
|
Mean OD570of 3 Aliquots (Blank Corrected) |
1.634 |
1.641 |
0.070 |
0.059 |
1.838 |
1.679 |
SD OD570 of 3 Aliquots |
0.037 |
0.022 |
0.000 |
0.001 |
0.019 |
0.022 |
Total Mean OD570of 2 Replicate Tissues (Blank Corrected) |
1.637* |
0.064 |
1.758 |
|||
SD OD570 of 2 Replicate Tissues |
0.005 |
0.008 |
0.112 |
|||
Mean Relative Tissue |
100.0 |
3.9 |
107.4 |
|||
Coefficient Of Variation [%]** |
0.3 |
12.1 |
6.4 |
*corrected mean OD570of the negative control corresponds to 100% absolute tissue viability.
**coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is ≤ 30%.
***The mean absolute OD570of the negative control is ≥ 0.8 and ≤ 2.8
Table 3: Results of 60 min Experiment
Name |
Negative Control |
Positive Control |
Test Item |
|||
Replicate Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
1.886 |
1.821 |
0.103 |
0.122 |
1.305 |
1.276 |
1.765 |
1.868 |
0.103 |
0.116 |
1.279 |
1.194 |
|
1.772 |
1.829 |
0.100 |
0.118 |
1.281 |
1.210 |
|
Mean Absolute OD570 |
1.823**** |
0.110 |
1.257 |
|||
OD570- Blank Corrected |
1.836 |
1.771 |
0.053 |
0.072 |
1.255 |
1.226 |
1.715 |
1.818 |
0.053 |
0.066 |
1.229 |
1.144 |
|
1.722 |
1.779 |
0.050 |
0.068 |
1.231 |
1.160 |
|
Mean OD570of 3 Aliquots (Blank Corrected) |
1.757 |
1.789 |
0.052 |
0.069 |
1.238 |
1.177 |
SD OD570 of 3 Aliquots |
0.068 |
0.025 |
0.001 |
0.003 |
0.015 |
0.043 |
Total Mean OD570of 2 Replicate Tissues (Blank Corrected) |
1.773* |
0.060 |
1.207 |
|||
SD OD570 of 2 Replicate Tissues |
0.023 |
0.012 |
0.044 |
|||
Mean Relative Tissue |
100.0 |
3.4** |
68.1 |
|||
Coefficient Of Variation [%]*** |
1.3 |
19.7 |
3.6 |
*corrected mean OD570of the negative control corresponds to 100% absolute tissue viability.
**mean relative tissue viability of the 60 min positive control is ≤ 15%,
***coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is ≤ 30%.
****The mean absolute OD570of the negative control is ≥ 0.8 and ≤ 2.8
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The mean relative tissue viability (% negative control) was above 15% after 60 min treatment and above 50% after 3 min treatment. Therefore, the test item is classified as “non-corrosive“.
- Executive summary:
In a primary skin corrosion study conducted according to OECD guideline 431, two EpiDerm tissues per exposure time were exposed to 25 mg of N1,N3 -diallylpropane-1,3 -diamine dihydrochloride (100% purity) for 60 min and 3 min. Cytotoxicity was measured in comparison to the concurrent negative controls via the MTT reduction assay and irritation was scored by the method of mean relative tissue viability. The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was ≥15% (68.1%) after 60 min treatment and ≥50% (107.4%) after 3 min treatment. The controls confirmed the validity of the study and all acceptance criteria were fulfilled.
Based on the results from this study, the test item can be classified as non-corrosive. To specify the classification in accordance to CLP regulation 1272/2008 the results from an OECD 439 study must be additionally consulted.
The study is acceptable and satisfies the guideline requirements for an in vitro skin corrosion study (OECD 431).
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