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EC number: 606-051-0 | CAS number: 185323-46-0
- 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)
- 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- activation of keratinocytes
Test material
- Reference substance name:
- Rape oil, polymer with tung oil
- EC Number:
- 606-051-0
- Cas Number:
- 185323-46-0
- IUPAC Name:
- Rape oil, polymer with tung oil
Constituent 1
In vitro test system
- Details on the study design:
- KeratinoSens cells were plated on 96-well tissue culture treated black walled clear bottom polystyrene plates, 125µL per well. The cells were left for 24 h to adhere and the media was replaced with a low serum medium prior to dosing with the test compound at a range of 12 concentrations (see Assay Summary for details). Each compound is dosed on two separate plates, one to determine luminsence (Keap1-Nrf2-ARE pathway) and a second to determine cytotoxicity (MTT cell viability assay). Following an incubation period of 48 h, the cells were either lysed and assessed for the luciferase reporter gene expression using a luminescent assay (Luciferase Assay Kit, Promega) and the BioTek luminometer or loaded with MTT [yellow; 3-(4,5-dimethyl-2-thiazolyl)-2,5-diphenyl-2H-tetrazolium bromide]. After 4 hour incubation the resulting formazan from the MTT cell viability assay was solubilised in a 10% SDS solution. The plates were then scanned at 570nm using a SunriseTM microplate absorbance reader (TECAN).
Results and discussion
In vitro / in chemico
Results
- Key result
- Run / experiment:
- mean
- Parameter:
- other: Calc. EC1.5 (%)
- Value:
- 0.015
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
|
Test Compound Response |
||||||
Compound Id |
Calc.EC1.5(%) |
Flag |
Sensitizing |
||||
|
Exp. 1 |
Exp. 2 |
Exp. 3 |
Mean±SD |
|
Potential |
|
PhytoVie® Defense |
0.0149 |
>0.02 |
>0.02 |
0.0149 |
1/3 |
|
No (-) |
Calc. EC1.5 : Effective concentration at 1.5 fold increase.
Flag : The number of experiments showing a sensitizing potential out of the total number of experiments. Yes (+) Compound shows sensitizing potential.
No (-) : Compound does not show sensitizing potential.
No (-) * : Compound shows borderline senstizing potential.
Assay Summary |
|
Incubation time: |
48h |
Concentrations (%): |
0.00001, 0.00002, 0.00004, 0.00008, 0.00016, 0.000315, 0.00063, |
|
0.00125, 0.0025, 0.005, 0.01, 0.02 |
Replicates per concentration: |
3 |
Cell model: |
KeratinoSens |
Vehicle: |
DMSO |
MW: |
999.99 |
KeratinoSens vehicle SD: |
10% (passed), 16% (passed), 10% (passed) |
Certified on: |
2018-04-17 |
Data Summary
|
Calc.IC30(%) |
MR (%) |
MR(%) |
Cell viability (MTT) 1 |
>0.02 |
NR |
NR |
Cell viability (MTT) 2 |
>0.02 |
NR |
NR |
Cell viability (MTT) 3 |
>0.02 |
NR |
NR |
|
Sensitizing Potential |
Calc.EC1.5(%) |
MR(Imax) |
MR(%) |
|
KeratinoSens 1 |
|
Yes (+) |
0.0149 |
1.58 |
0.02 |
KeratinoSens 2 |
|
No (-) |
>0.02 |
NR |
NR |
KeratinoSens 3 |
|
No (-) |
>0.02 |
1.41 |
0.02 |
Calc. EC1.5 : Effective concentration at 1.5 fold increase.
Calc. IC30 : Inhibitory concentration at 30% loss of cell viability. MR (Imax ) Maximum fold response of KeratinoSens.
MR (%) : Maximum % response.
MR (%) : Maximum fold response concentration.
Yes (+) : Compound shows sensitizing potential.
No (-) : Compound does not show sensitizing potential.
No (-) * : Compound shows borderline senstizing potential. NR No response observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Compound does not show sensitizing potential.
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