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Diss Factsheets
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EC number: 605-924-3 | CAS number: 181314-46-5
- 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
- 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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Waxes and Waxy substances, jojoba, iso-Pr esters
- EC Number:
- 605-924-3
- Cas Number:
- 181314-46-5
- Molecular formula:
- No molecular formula available (UVCB)
- IUPAC Name:
- Waxes and Waxy substances, jojoba, iso-Pr esters
- Details on test material:
- Substance %
Isopropyl Jojobate 30 – 40
Jojoba Alcohols 30 – 40
Jojoba Esters 30 – 40
Constituent 1
- Specific details on test material used for the study:
- Isopropyl Jojobateand Jojoba Alcohol and Jojoba Esters
Article number: 18AC47
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- EpiOcular™ Human Cell Construct (MatTek Corporation)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- 50 µL
- Duration of treatment / exposure:
- The EpiOcular™ tissues were treated in
duplicate with each test article, positive control, or negative control. Prior to test article or control article applications, each tissue surface was moistened with 20 μL of Ca++Mg++-free DPBS and incubated at standard culture conditions for 30 minutes. After incubation, the EpiOcular™ tissues were tested in duplicate with 50 μL of the test article, positive control, or negative control. The tissues were then placed back into the incubator after dosing and incubated at standard culture conditions for the remainder of the 30 minute exposure. - Number of animals or in vitro replicates:
- EpiOcular™ tissues were treated in duplicate with the test articles, Isopropyl Jojobate and Jojoba Alcohol and Jojoba Esters, and Hydrolyzed Jojoba Esters, in one valid
definitive trial.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Mean cell viability (%)
- Remarks:
- MTT assay
- Value:
- ca. 99.2
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
MTT Assay
The EpiOcular™ cultures were treated in duplicate with the test articles, Isopropyl Jojobate and Jojoba Alcohol and Jojoba Esters, and Hydrolyzed Jojoba Esters, for an exposure time of 30 minutes. The negative and positive controls were also exposed in duplicate for 30 minutes. Table 1 summarizes the percent viability results of the Topical Application Ocular Irritation Screening Assay Using the EpiOcular™ Human Cell Construct for the test articles and the positive control, Methyl Acetate. The raw and analyzed data for the test articles, negative control, and positive control are included in Appendix B.
The test articles were observed to reduce MTT directly in the absence of viable cells; therefore a killed control experiment was performed. Additional calculations were performed to correct for the amount of MTT reduced directly by test article residues as described in the Presentation of Data section. The test articles were not observed to be colorants in isopropanol; therefore a colorant control was not performed.
The test articles, Isopropyl Jojobate and Jojoba Alcohol and Jojoba Esters, and Hydrolyzed Jojoba Esters, resulted in relative viabilities of 99.2% and 112.8% respectively, and are predicted to not require classification or labelling for ocular irritation (GHS No Category).
Deviation
The EpiOcular™ tissues were initially incubated in assay medium for 1 hour and 23 minutes prior to transferring the tissues to fresh assay medium. This is a deviation from the protocol which states that they will be incubated at standard culture conditions for one hour. Although the transfer of the tissues was delayed, they were transferred to fresh assay medium prior to the overnight incubation of 16-24 hours. The purpose of the replacing the assay medium after 1 hour, is to replenish nutrients and growth factors used during the initial incubation which was accomplished; therefore this deviation did not have an adverse impact on the study results.
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Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test articles, Isopropyl Jojobate and Jojoba Alcohol and Jojoba Esters resulted in relative viabilities of 99.2% and are predicted to not require classification or labelling for ocular irritation (GHS No Category).
- Executive summary:
The test articles, Isopropyl Jojobate and Jojoba Alcohol and Jojoba Esters resulted in relative viabilities of 99.2% and are predicted to not require classification or labelling for ocular irritation (GHS No Category).
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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