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EC number: 228-207-3 | CAS number: 6168-72-5
- 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 substance was evaluated in three studies:
- a reduced LLNA, which cannot be used for classification (only one tested concentration and formation of scars may bias results and exclude the derivation of an EC3)
- a DPRA which was negative;
- a Keratinosens assay which was also negative.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- study performed before guideline was adopted
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 luciferase KeratinoSens™ test method)
- Version / remarks:
- study run before adoption of guideline
- GLP compliance:
- no
- Remarks:
- Close to GLP: Report signed by lead scientist, study director and technical reviewer, and includes all information and raw data.
- Type of study:
- ARE-Nrf2 luciferase KeratinoSens™ test method
- Details of test system:
- Keratinoses transgenic cell line [442D]
- Details on the study design:
- 12 test concentrations from 0.98 to 2000 µM
- Vehicle / solvent control:
- DMSO
- Positive control:
- cinnamic aldehyde [442D]
- Positive control results:
- Keratinocytes exposed to CA exhibited dose dependent increase in luciferase activity on for each of the three replicates conducted on different days. The average EC1.5 (12.84 μM), maximum luciferase induction (4.39 fold) and cytotoxicity for CA were within the assay acceptable range. Similarly, average background variability for the three replicates was less than 9%, which was within the assay acceptance range. Based on these observations, all three replicates of the assay were considered acceptable.
- Key result
- Group:
- test chemical
- Parameter:
- EC 1.5 [442D]
- Remarks:
- not determined: <1.5-fold luciferase induction at all test concentrations
- Cell viability:
- >90% at all test concentrations
- Remarks on result:
- no indication of skin sensitisation
- Outcome of the prediction model:
- negative [in vitro/in chemico]
- Other effects / acceptance of results:
- CA (positive control) was considered positive when the luciferase induction by CA was
statistically significant (by t-test) and above the threshold of 1.5 fold induction in at least
one dose level and cell viability at that dose was greater than 70%.
Maximum luciferase induction (Imax) and EC1.5 (test material concentration at which
luciferase induction is greater than 1.5 fold) was calculated for CA. The assay was
considered acceptable only if at least one of the two following criteria were fulfilled:
• Average luciferase induction in the three replicates for CA at 64 μM between 2 and 8.
• The EC1.5 was between 7.5 μM and 30 μM.
The average variability in the 6 solvent control wells of each of the three parallel test plates was calculated. The assay was considered acceptable only when the variability was below 20%. - Interpretation of results:
- GHS criteria not met
- Executive summary:
DL-Alaninol was evaluated for skin sensitization potential using the KeratinoSensTM assay. The assay uses a human keratinocyte cell line (HaCaT) in which activation of the Nrf2-ARE pathway is quantified via a luciferase reporter gene assay to assess chemical reactivity which is equated to sensitization potential. The test chemical was tested at twelve concentrations ranging from 1 to 2000 μM. A test chemical is considered positive for reactivity and sensitization potential when it induces luciferase activity greater than 1.5 fold with less than 30% cytotoxicity when compared to the solvent control.
In all independent replicates, the positive control compound, cinnamic aldehyde, was positive demonstrating appropriate assay conduct.DL-alaninol was negative for reactivity in the KeratinoSensTM assay and is considered to lack skin sensitization potential.
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Details of test system:
- cysteine peptide, (Ac-RFAACAA-COOH)
- lysine peptide (Ac-RFAAKAACOOH)
- Details on the study design:
- The Direct Peptide Reactivity Assay was used to assess the skin sensitization potential of the test article. Synthetic peptides containing cysteine or lysine were reacted with each test article for 24 ± 2 hours. After the incubation period, the extent of peptide depletion was analyzed using High Performance Liquid Chromatography (HPLC) coupled with ultra-violet (UV) spectrometric detection.
- Vehicle / solvent:
- acetonitrile
- Positive control:
- cinnamic aldehyde
- Positive control results:
- Mean Peptide Depletion (%): 71.41 for Cysteine, 62.87 for Lysine
- Key result
- Group:
- test chemical
- Parameter:
- lysine depletion
- Value:
- 3.39 %
- At concentration:
- 100 mM
- Positive controls validity:
- valid
- Key result
- Group:
- test chemical
- Parameter:
- cysteine depletion
- Value:
- 3.71 %
- At concentration:
- 100 mM
- Positive controls validity:
- valid
- Outcome of the prediction model:
- no or minimal reactivity [in chemico]
- Other effects / acceptance of results:
- The assay was accepted as the following criteria were met:
1) Each standard curve must have an r2 > 0.990 => criterion met
mean peptide concentration of reference controls A and C = 0.50 ± 0.05 mM => criterion met
peak area CV for reference controls B and C must be < 15% => criterion met
2) percent peptide depletion for cysteine peptide with positive control > 60.8% => criterion met
and SD for replicates < 14.9 => criterion met
percent peptide depletion for lysine peptide with positive control: 40.2 to 69% => criterion met
and SD for replicates < 11.6 => criterion met
3) SD of test substance replicates < 14.9% for cysteine depletion => criterion met
SD of test substance replicates <11.6% for lysine depletion => criterion met - Interpretation of results:
- GHS criteria not met
- Executive summary:
The test article, d,l-2-amino-1-propanol, was evaluated for skin sensitization potential using the Direct Peptide Reactivity Assay (DPRA) in 1 definitive trial.
The % peptide depletion was 3.71% (Cysteine) and 3.39% (Lysine). Based on these results, d,l-2-amino-1-propanol was predicted to be a non-sensitizer.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
The substance is considered non-sensitizing based on results of two in vitro/in chemico studies. The third study, a reduced LLNA method, cannot be used for classification.
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