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EC number: 947-782-8 | CAS number: -
- 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:
- 08/02/2018 - 03/04/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Deviations:
- no
- Remarks:
- see principles of method below for full details
- Principles of method if other than guideline:
- Deviations from the guidelines:
- Standard states MTT musted be used for an incubation period of 4 hours, solubilised overnight in 10% SDS and read at 690 nm, the study uses MTT for a 3 hr incubation period, which is solubilised in isopropanol and read at 570 nm.
- The standard states that cinnamic aldehyde must be used at 4 - 64 μM, whereas the study uses cinnamic aldehyde 8 - 128 μM. - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- The test (KeratinoSens) test is a method for which validation studies have been completed followed by an independent peer review conducted by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and is considered scientifically valid when used as part of an integrated approach to testing to determine skin sensitisers and non-sensitisers for the purposes of hazard classification and labelling.
Test material
- Reference substance name:
- Reaction products of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid
- IUPAC Name:
- Reaction products of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid
- Test material form:
- solid: bulk
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0001230562
- Expiration date of the lot/batch: 08/06/2019
- Purity test date: N/A
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Assumed to be stable
- Stability under test conditions:Assumed to be stable
- Solubility and stability of the test substance in the solvent/vehicle: Assumed to be stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Assumed to be stable
In vitro test system
- Details on the study design:
- Skin sensitisation (In vitro test system) - Details on study design: Using a test system (KeratinoSens cell line (test system) derived from the HaCaT human keratinocytes) a luciferase reporter gene transcriptionally controlled by the Anti-oxidant Response Element from a gene that is known to be up regulated in contact with sensitisers was quantitatively measured. Experiments were performed in plates where cells were exposed to in individual concentrations of the test substance or appropriate control substances. Test concentrations were determined based on the solubility of the test item in ethanol (max. 20 mg/mL in Ethanol), and for subsequent dilution in cell culture medium a top concentration of 200 μg/mL) with 3 replicates per concentration per treatment.
Results and discussion
- Positive control results:
- The positive control, 'Cinnamic Aldehyde' showed that there was a dose-dependent increase of induction, which was > 1.5 - fold in at least one concentration and the CV% of blank values was < 20% so was accepted. The positive control was positive at both 64 and 129 μM.
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: Test Item
- Parameter:
- other: EC1.5
- Value:
- 1.5
- Vehicle controls validity:
- not valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Run / experiment:
- other: Test item
- Parameter:
- other: Imax
- Value:
- 0.854
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Not specified.
- Acceptance criteria met for positive control: Not all criteria met, however considered valid based on Positive Control results.
- Acceptance criteria met for variability between replicate measurements: No specified.
- Range of historical values if different from the ones specified in the test guideline: Same.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Reaction products of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid was classified as a Non-sensitiser to human skin as EC1.5 value value did not exceed the minimum threshold (1.5) and the Imax value was between 0.854 - 1.183.
- Executive summary:
The study assesses the In vitro sensitisation potential of Reaction products of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid using the test system (KeratinSens test method). The study is GLP compliant and is performed according to the OECD 442D guidelines. The experiment use the quantification of luciferase expression in the cell reporter line to determine the response to the test item, a negative control and a positive control, reporting the EC1.5 and Imax values. In all test item experiments the EC1.5 value did not exceed the minimum threshold value (1.5) and the Imax value range was 0.854 - 1.183, which lead to conclusion that the test item is not a skin sensitiser (GHS criteria determined).
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