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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- experimental start/end date: 13/03/2018 - 15/03/2018
- 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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- 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
Test animals / tissue source
- Species:
- human
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount / concentration applied:
- TREATMENT OF LIQUID TEST ARTICLES
1) Pre-Treatment: After the overnight incubation, the tissues were pre-wetted with 20 μL of Ca++Mg++Free DPBS.
The tissues were incubated at standard culture conditions for 30 ± 2 minutes.
2) Test article exposure: After the 30 ± 2 minute Ca++Mg++Free-DPBS pre-treatment, each liquid test and control article was tested by applying 50 μl topically on the EpiOcular™ tissues. The tissues were incubated at standard culture conditions for 30 ± 2 minutes.
Dosing details: 50 μl of the test article were applied directly on the tissue so as to cover the upper surface
3) Rinsing: At the end of the 30 ± 2 minutes treatment time, the test articles were removed by extensively rinsing the tissues with Ca++Mg++-free D-PBS (brought to room temperature). Three clean beakers (glass or plastic with minimal 150 ml capacity), containing a minimum of 100 ml each of Ca++Mg++-free D-PBS were used per test article.
4) Post-Soak: After rinsing, the tissues were immediately transferred to and immersed in 5 ml of previously warmed Assay Medium (room temperature) in a pre-labeled 12-well plate for a 12 ± 2 minutes immersion incubation (Post-Soak) at room temperature. This incubation in Assay Medium was intended to remove any test article absorbed into the tissue.
5) Post-incubation: At the end of the Post-Soak immersion, each insert was removed from the Assay Medium, the medium was decanted off the tissue, and the insert was blotted on absorbent material, and transferred to the appropriate well of the pre-labeled 6-well plate containing 1 ml of warm Assay Medium. The tissues were incubated for 120 ± 15 minutes at standard culture conditions (Post-treatment Incubation). - Duration of treatment / exposure:
- 30 minutes
- Observation period (in vivo):
- 12 + 120 minutes
- Duration of post- treatment incubation (in vitro):
- 12+120 minutes
- Number of animals or in vitro replicates:
- 6 replicates
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Percentage of the cell viability (%)
- Value:
- 97.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
18E0447 (18E0447-1PL) 15.03.2018 |
||||
BLANK |
NEGATIVE CONTROL |
POSITIVE CONTROL |
18E0447 (-1PL) |
%NSMTT |
0,034 |
1,870 |
0,623 |
1,784 |
0,1420 |
0,034 |
1,866 |
0,616 |
1,861 |
0,1458 |
0,034 |
1,860 |
0,535 |
1,889 |
0,0996 |
0,034 |
1,871 |
0,545 |
1,906 |
0,0984 |
|
1,778 |
0,515 |
2,019 |
0,1558 |
1,777 |
0,521 |
1,909 |
0,1533 |
VIABILITY [%] |
100,0% |
29,1% |
103,2% |
5,5% |
TRUE TISSUE VIABILITY |
= [%Viability test] - [%NSMTT] |
97,8% |
This report relates only to the study product provided by the customer and submitted to this study.
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) “ isno 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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