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EC number: 289-964-3 | CAS number: 90045-98-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Simmondsia chinensis N., Buxaceae.
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 luciferase KeratinoSens™ test method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- ARE-Nrf2 luciferase KeratinoSens™ test method
Test material
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- Jojoba Esters
- Cas Number:
- 61789-91-1
- IUPAC Name:
- Jojoba Esters
- Reference substance name:
- Alcohols, C14-22 and C16-22-unsatd.
- EC Number:
- 268-107-7
- EC Name:
- Alcohols, C14-22 and C16-22-unsatd.
- Cas Number:
- 68002-95-9
- IUPAC Name:
- Alcohols, C14-22 and C16-22 unsaturated
- Reference substance name:
- Fatty acids, C14-22 and C16-22-unsatd., potassium salts
- EC Number:
- 286-079-4
- EC Name:
- Fatty acids, C14-22 and C16-22-unsatd., potassium salts
- Cas Number:
- 85186-93-2
- IUPAC Name:
- Fatty acids, C14-22 and C16-22 unsaturated, potassium salts
- Test material form:
- semi-solid (amorphous): gel
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- the test product was applied diluted in the range from 0,98 to 2000 μM or from 0,196 to 400 μg/ml.
In vitro test system
- Details of test system:
- Keratinoses transgenic cell line [442D]
- Details on the study design:
- 442D
The test was performed by using the instaCELL® KeratinoSens® assay kit protocol (Accelerate, Cat N° SF220-01) in accordance with DB-ALM Protocol n° 155: KeratinoSens™ Skin Sensitisation & Allergic Contact Dermatitis and OECD Test No. 442D: In Vitro Skin Sensitisation assays addressing the AOP key event on keratinocyte activation.
The KeratinoSens® cells have been developed by stable transfection of a human keratinocyte cell line (HaCaT) with a luciferase reporter gene (pGL2, Promega) controlled by a Nrf2 responsive enhancer element from the AKR1C2 gene. Under nonstressed conditions, the Nrf2 transcription factor is covalently bound to Keap1 in the cytoplasm. This binding leads to ubiquitination and degradation of Nrf2 and therefore to inhibition of the antioxidant response. Under conditions of electrophilic stress, sensitizers covalently bind to Keap1, and Nrf2 is released into the nucleus. In the nucleus, Nrf2 binds to the promoter
region of the antioxidant response element (ARE) and initiates the expression of cytoprotective enzymes. The expression of luciferase in stressed KeratinoSens® cells is proportional to the activation of the Nrf2/Keap1 pathway activated by sensitizers.
KeratinoSens® cells has been validated by the ECVAM and adopted by the OECD TG 422D.
Cells were seeded in a 96 well plate at 37°C, 5% CO2 until cultures reach confluency.
Medium was replaced with new medium and the test product was applied diluted in the range from 0,98 to 2000 μM or from 0,196 to 400 μg/ml. The test product exposition last for 48 hours.
Resauzurin was added to each well for 4 hours at 37°C, then fluorescence at 540EX/590EM was measured to determine the viability of the cells
Cells were then washed with PBS and One-GloTM reagent was dispensed to each well. The plate was incubated again at room temperature in the dark for 20 min and luminescence was measured with an integration time of 1 s/ well. Test was performed in three trials.
Ethylene glycol dimethylacrylate (EGDMA) was tested as a positive control.
Assay buffer, containing 1% DMSO was used as negative control. - Vehicle / solvent control:
- water
- Negative control:
- other: Assay buffer, containing 1% DMSO was used as negative control
- Positive control:
- EGDMA (120 M) [442D]
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- EC 1.5 [442D]
- Value:
- 12.4 µg/mL
- Cell viability:
- valid
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- EC 1.5 [442D]
- Value:
- 127.95 µg/mL
- Cell viability:
- Valid
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test material is a skin sensitizer
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