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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
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- bis(prop-2-en-1-yl)amine hydrochloride
- EC Number:
- 612-154-1
- Cas Number:
- 6147-66-6
- Molecular formula:
- C6H11N.HCl
- IUPAC Name:
- bis(prop-2-en-1-yl)amine hydrochloride
- Test material form:
- liquid
- Remarks:
- Salt dissolved in water
Constituent 1
- Specific details on test material used for the study:
- 66% purity
Aqueous solution
In vitro test system
- 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]
Results and discussion
- 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
In vitro / in chemico
Results
- 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
Applicant's summary and conclusion
- 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.
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