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EC number: 612-154-1 | CAS number: 6147-66-6
- 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
Endpoint summary
Administrative data
Description of key information
The skin sensitisation potential of 2-propen-1-amine, N-2-propen-1-yl-, hydrochloride was assessed using an in vitro KeratinoSens assay according to OECD guidelines 442D during a GLP compliant study.
After 48 hours of exposure of cells with 12 concentrations of 2-propen-1-amine, N-2-propen-1-yl, hydrochloride, Luciferase measurements and MTT viability testing were performed.
Acceptance criteria for the positive control (cinnamic aldehyde) were met.
The test item did not induce a significant luciferase induction >1.5 and the mean Imax value was 0.949 uM. The statistical significance, viability, dose response and dose acceptance criteria were all met.
2-propen-1-amine, N-2-propen-1-yl, hydrochloride was classified as neagtive according to the KeratinoSens prediction model.
The skin sensitisation potential of 2-propen-1-amine, N-2-propen-1-yl-, hydrochloride was assessed using an in vitro direct peptide reactivity assay according to OECD guidelines 442C during a GLP compliant study.
After 24 hours of the test item being incubated with either cysteine or lysine they were run on a HPLC system and assessed according to the Cysteine 1:10/Lysine 1:50 predicition mode.
Acceptance criteria for the positive control (cinnamic aldehyde) were met.
The test item showed no or minial reactivity and the DPRA prediction was negative. All acceptance criteria were all met.
2-propen-1-amine, N-2-propen-1-yl, hydrochloride was classified as negative as per the prediction model.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 2021 to June 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: Direct Peptide Reactivity Assay
- Specific details on test material used for the study:
- 66% purity
Aqueous solution - Details on the study design:
- Test items were incubated for 24 h +/- 2 h at 25 oC in solution at 100 mM in combination with either cysteine or lysine containing peptides and then run on an HPLC system (20 minute run time) using gradient elution and UV detection at 220 nm to measure peptide concentration.
Test items were compared to reference controls containing the test item solvent in combination with either cysteine or lysine peptide in order to determine the relative percent peptide depletion. Relative percent peptide depletion values were used in a prediction model that assigns test items to one of four reactive classes.
Acceptance Criteria
-Standard curve must have an r2 value >0.99
-The mean percent depletion value of the three replicates for the positive control cinnamic aldehyde should be between 60.8% and 100% for the cysteine peptide and between 40.2% ad 69.4% for the lysine peptide.
-The standard deviation for the positive control replicates should be <14.9% for the percent cysteine depletion and <11.6% for the percent lysine depletion
-Mean peptide concentration of reference controls A should be 0.5 +/- 0.05 mM
-The coefficient of variation (CV) of peptide peak areas for the 9 reference controls B and C should be <15%.
The standard curve is used to assign concentrations to test items and controls.
The RefA controls are peptide plus acetonitrile, prepared to endure peptide concentration is within specified limits.
RefB controls are peptide plus acetonitrile, prepared to ensure peptide stability throughout the run is within the specified limits.
RefC controls are peptide plus acetonitrile and test item solvent, prepared as a control to assess percent peptide depletion.
Using the cysteine 1:10/lysine 1:50 prediction model to assess reactivity classes
0% < mean % depletion <6.38% - No or minimal reactivity - DPRA prediction is negative
6.38% < mean % depletion <22.62% - low reactivity - DPRA prediction is positive
22.62% < mean % depletion <42.47% - moderate reactivity - DPRA prediction is positive
42.47% < mean % depletion <100% - high reactivity - DPRA prediction is positive - Vehicle / solvent control:
- water
- Positive control:
- cinnamic aldehyde [442D]
- Positive control results:
- Positive control had a cysteine depletion of 75.031% and is within the acceptance criteria
Positive control had a lysine depletion of 61.90% and is within the acceptance criteria - Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- other: Mean% Peptide Depletion (Cys + Lys)
- Value:
- 1.366 %
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Outcome of the prediction model:
- negative [in vitro/in chemico]
- Other effects / acceptance of results:
- All acceptance criteria met
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 2-propen-1-amine, N-2-propen-1-yl-, hydrochloride did not meet the criteria for classification as a skin sensitiser.
- Executive summary:
The skin sensitisation potential of 2-propen-1-amine, N-2-propen-1-yl-, hydrochloride was assessed using an in vitro direct peptide reactivity assay according to OECD guidelines 442C during a GLP compliant study.
After 24 hours of the test item being incubated with either cysteine or lysine they were run on a HPLC system and assessed according to the Cysteine 1:10/Lysine 1:50 predicition mode.
Acceptance criteria for the positive control (cinnamic aldehyde) were met.
The test item showed no or minial reactivity and the DPRA prediction was negative. All acceptance criteria were all met.
2-propen-1-amine, N-2-propen-1-yl, hydrochloride was classified as negative as per the prediction model.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 2021-June 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 luciferase KeratinoSens™ test method)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- ARE-Nrf2 luciferase KeratinoSens™ test method
- Specific details on test material used for the study:
- 66% purity
Aqueous solution - Details of test system:
- Keratinoses transgenic cell line [442D]
- Details on the study design:
- 442D
PREPARATION AND ADIMISTRATION OF TEST SOLUTIONS
- test item: Per plate, a single application of 12 concentrations (2000, 1000, 500, 125, 62.5, 31.25, 15.625, 7.813, 3.906, 1.953 and 0.977 uM) of the test item was applied in cell culture medium (dilution factor of 2) with a final concentration of ethanol of 1%. The top concentration was previously determined by solubility testing.
- Positive controls: Per plate, a single application of 5 concentrations (8, 16, 32, 64 and 128 uM) of the positive control (cinnaminc aldehyde) was applied in cell culture medium (dilution factor of 2) with a final concentration of ethanol of 1%.
- Preparation of the solvent and negative controls: Per plate, a single application of culture medium with 1% ethanol was applied as the negative control (6 wells per plate). One well per plate was left empty (no cells).
DOSE RANGE FINDING ASSAY:
The test concentrations of 2-propen-1-amine, N-2-propen-1-yl, hydrochloride used in the study were selected on the basis of solubility testing carried out during the study. Solubility of the test item was confirmed up to 200 mM in 1% ethanol in cell culture medium. Subsequent dilution in cell culture medium gave a top concentration of 2000 uM.
APPLICATION OF THE TEST CHEMICAL AND CONTROL SUBSTANCES
- Number of repetitions: Four repetitions were performed. Each repetition consisted of 3 x 96-well plates for luminescence (n=12 overall) and 2 x 96-well plates for MTT (n=8 overall).
- Exposure time: Cells were incubated with the test or reference item for 48 +/- 2 hours prior to endpoint measurements.
- Study evaluation and decision criteria used: A test item is considered positive if the following conditions are met in 2 of 3 repetitions:
1. The Imax is greater than or equal to 1.5-fold and statistically significantly different as compared to the solvent negative control (as determined by a two-tailed, unpaired student's T-test)
2. The cellular viability is higher than 70% at the lowest concentration with induction of luciferase activity greater than or equal to 1.5-fold. Test items that only induce gene activity at cytotoxic levels are not rated positive, as in the case for some non-sensitising skin irritants.
3. The EC1.5 value is < 1000 uM or < 200 ug/mL for test items with no defined MW.
4. There is an apparent overall dose-response for luciferase induction (or biphasic response).
- Description on study acceptance criteria: Test results are acceptable if:
1. The positive control (cinnamic aldehyde) produced positive results, i.e the luciferase gene induction produced by this control is above the threshold of 1.5 in at least on of the tested concentrations and this induction is statistically significant compared to the solvent control.
2. The Imax and the EC1.5 for cinnamic aldehyde is calculated and meet either or both of the following targets:
-average induction in three replicates for cinnamic aldehyde at 32 uM is within the historical range (currently 1.6 and 3).
-EC1.5 value for cinnamic aldehyde is within the historical range (currently 6 uM and 39 uM).
SEEDING AND INCUBATION
Day 1 - Cell seeding (3 x 96-well plates for luminescence; 2 x 96-well plates fir MTT); 10,000 cells per well, passage number 17 for repetition 1 to 3, passage number 21 for repetition 4.
Day 2 - 24 hours after seeding, the test and control items were applied to plates and were incubated at 37 oC, 5% CO2, >95% relative humidity for 48 +/- 2 hours.
Day 4 - Evaluation of luciferase activity by luminescence (3 plates) and cell viability by MTT testing (2 plates). - Vehicle / solvent control:
- cell culture medium
- Negative control:
- other: Ethanol
- Positive control:
- cinnamic aldehyde [442D]
- Positive control results:
- The positive control produced an induction at >1.5-fold in 4 out of 5 concentrations meeting the acceptance criteria.
The EC1.5 value was 10.868. The meets the acceptance criteria of between 6 and 39 uM.
The CV% of blank values was 11.2626%. This meets the acceptance criteria of <20%.
The average induction of the positive control was 3.269. This failed the acceptance criteria as it should be between 1.6 and 3.0. However, as other acceptance criteria were met, and there was a dose-dependant increase of induction with the positive control the results were considered valid. - Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- Imax [442D]
- Value:
- 0.949 µM
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The test item did not induce a statistically significant luciferase induction >1.5 in either of the two valid repetitions. The statistical significance, viability, dose response and does acceptance criteria were all met and therefore the test item was classed as negative using the KeratinoSens prediction model.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 2-propen-1-amine, N-2-propen-1-yl-, hydrochloride did not meet the criteria for classification as a skin sensitiser.
- Executive summary:
The skin sensitisation potential of 2-propen-1-amine, N-2-propen-1-yl-, hydrochloride was assessed using an in vitro KeratinoSens assay according to OECD guidelines 442D during a GLP compliant study.
After 48 hours of exposure of cells with 12 concentrations of 2-propen-1-amine, N-2-propen-1-yl, hydrochloride, Luciferase measurements and MTT viability testing were performed.
Acceptance criteria for the positive control (cinnamic aldehyde) were met.
The test item did not induce a significant luciferase induction >1.5 and the mean Imax value was 0.949 uM. The statistical significance, viability, dose response and dose acceptance criteria were all met.
2-propen-1-amine, N-2-propen-1-yl, hydrochloride was classified as neagtive according to the KeratinoSens prediction model.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
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