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EC number: 288-327-7 | CAS number: 85711-66-6
- 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:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
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)
- Version / remarks:
- 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Resin acids and Rosin acids, esters with glycerol and diethylene glycol
- EC Number:
- 288-327-7
- EC Name:
- Resin acids and Rosin acids, esters with glycerol and diethylene glycol
- Cas Number:
- 85711-66-6
- Molecular formula:
- UVCB substance
- IUPAC Name:
- esterification product of (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylic acid; (1R,4aR,4bS,10aR)-1,4a-dimethyl-7-(propan-2-ylidene)-1,2,3,4,4a,4b,5,6,7,9,10,10a-dodecahydrophenanthrene-1-carboxylic acid; (1R,4aS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,5,6,9,10,10a-decahydrophenanthrene-1-carboxylic acid; (1R,4aS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,9,10,10a-octahydrophenanthrene-1-carboxylic acid and 2,2'-oxydiethanol and propane-1,2,3-triol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: Arakawa Chemical Lot K02007 and Lot W90402
- Purity, including information on contaminants, isomers, etc.: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: no data
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: no data
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: no data
- Reactivity of the test material with the incubation material used (e.g. plastic ware): no data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): material was powdered using a mortar and pestle
- Preliminary purification step (if any): no data
- Final concentration of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid (e.g. stock crystals ground to fine powder using a mortar and pestle): material was powdered using a mortar and pestle
FORM AS APPLIED IN THE TEST (if different from that of starting material) : material was powdered using a mortar and pestle
Test animals / tissue source
- Species:
- other: EpiOcular Reconstituted Human Cornea-like Epithelium (RhCE)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50mg
- Concentration (if solution): not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): 50mL
- Concentration (if solution): not applicable
- Lot/batch no. (if required): sterile water lot no. 2121448; methyl acetate lot no. 090120ALA
- Purity: ≥ 99.9% - Duration of treatment / exposure:
- 6 hours
- Duration of post- treatment incubation (in vitro):
- post-exposure incubatation of 18 hours
- Number of animals or in vitro replicates:
- three
- Details on study design:
- - Details of the test procedure used
: per guideline OECD 492
- Doses of test chemical and control substances used : 50 mg of test article and 50mL of control substances
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable) : 6 hour incubation exposure
- Justification for the use of a different negative control than ultrapure H2O (if applicable) : not applicable
- Justification for the use of a different positive control than neat methyl acetate (if applicable): not applicable
- Description of any modifications to the test procedure : not applicable
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals (if applicable) : no data
- Number of tissue replicates used per test chemical and controls (positive control, negative control, NSMTT, NSCliving and NSCkilled, if applicable) : three
- For hCE cells: number of runs and of hCE models used within each run : not applicable
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer) : 570nm
- Description of the method used to quantify MTT formazan, if applicable : no data
- For hCE cells: data of QC check for TEER measuring system : not applicable
- Description of the qualification of the HPLC/UPLC-spectrophotometry system (if applicable) : no data
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model : no data
- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria : see study report
- Complete supporting information for the specific RhCE tissue construct or hCE cells used : see study report
- Reference to historical data of the RhCE tissue construct / hCE cells : see study report
- Demonstration of proficiency in performing the test method before routine use by testing of the proficiency chemicals : no data
- Positive and negative control means and acceptance ranges based on historical data : see study report
- Acceptable variability between tissue replicates for positive and negative controls : no data
- Acceptable variability between tissue replicates for the test chemical: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): three washes following 6 hour exposure
SCORING SYSTEM: Prediction model per OECD 492
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- mean percent tissue viability
- Run / experiment:
- lot K02007
- Value:
- 89
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- mean percent tissue viability
- Run / experiment:
- lot W90402
- Value:
- 103
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the OECD Guideline 492 prediction model, rosin acid derivative is not classified for eye irritation.
- Executive summary:
A GLP-compliant, OECD Guideline 492 in vitro eye irritation test was performed with rosin acid derivative. 50mg of the test article was applied to EpiOcular Reconstituted Human Cornea-like Epithelium (RhCE) and the treated tissue was incubated for 6-hours. Three replicates were performed. 50mL of sterile was was used as a negative control and 50mL of methyl acetate was used as a positive control. Following treatment, an MTT assay was performed to assess tissue viability as percent of the negative control. The data for the lots was 89% and 103% tissue viability. A mean tissue viability percentage of greater than 60% indicates that no classification is required. Based on the OECD Guideline 492 prediction model, rosin acid derivative is not classified for eye irritation.
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