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Diss Factsheets
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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- eperimental start/end date: 27/03/2018 - 29/03/2018
- 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Test chemicals were administered neat by topical application onto the construct.
16μL (32μL/cm2) - Duration of treatment / exposure:
- 42 minutes at room temperature.
- Duration of post-treatment incubation (if applicable):
- incubated at 37°C for 42 additional hours.
- Number of replicates:
- 6
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 89
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Mean OD | SD | Mean OD | |||||||
1 | BLANK | 0.033 | 0.033 | 0.033 | 0.033 | 0.0% | 0.033 | ||
2 | 0.034 | 0.033 | 0.033 | 0.033 | Cell viability [%] | ||||
1 | NEGATIVE CONTROL | 1.223 | 1.218 | 1.23 | 1.224 | 1.8% | 1.214 | ODNC=ODNC raw- ODblank | 100.0% |
2 | 1.229 | 1.23 | 1.217 | 1.225 | 1.181 | ||||
3 | 1.187 | 1.199 | 1.194 | 1.193 | |||||
1 | POSITIVE CONTROL | 0.051 | 0.051 | 0.052 | 0.051 | 0.2% | 0.049 | 1.4% | |
2 | 0.049 | 0.049 | 0.049 | 0.049 | 0.016 | ||||
3 | 0.048 | 0.047 | 0.047 | 0.047 | |||||
1 | 18P0447-1PL | 1.121 | 1.129 | 1.103 | 1.117 | 3.0% | 1.084 | 89.0% | |
2 | 1.085 | 1.072 | 1.069 | 1.075 | 1.051 | ||||
3 | 1.062 | 1.06 | 1.054 | 1.059 |
According to the classification of the official method and under the conditions of the assay, the product: “PhytoVie® Defense (INCI: Brassica Campestris/Aleurites Fordi Oil Copolymer)” is no irritant.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Substance is shown to be not irritating under the conditions of the study.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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