Registration Dossier
Registration Dossier
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EC number: 288-327-7 | CAS number: 85711-66-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- 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: no data
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: not applicable
- 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: not applicable
- 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): unchanged
- 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): unchanged
FORM AS APPLIED IN THE TEST (if different from that of starting material) : unchanged
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The test system, when used according to the OECD 439 protocol, may be used to determine change in tissue vaibility following exposure to a test article which allows for an estimation of skin irritation potential.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek EpiDerm Reconstructed Human Epidermic (RhE)
- Tissue batch number(s): Lot 33722
- Production date: - Shipping date: no data
- Delivery date: no data
- Date of initiation of testing: 2020-09-16
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37C
- Temperature of post-treatment incubation (if applicable): 37C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: tissues were washed with a stream of DPBS and blotted with a sterile cotton swab and paper towel
- Observable damage in the tissue due to washing: no data
- Modifications to validated SOP: no data
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/mL in DMEM
- Incubation time: 3 hours
- Spectrophotometer: no data
- Wavelength: 570nm
- Filter: no data
- Filter bandwidth: no data
- Linear OD range of spectrophotometer: no data
NUMBER OF REPLICATE TISSUES: three
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: one
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritating to skin if the mean tissue viability is less than or equal to 50% following a 1 hour exposure.
- The test substance is considered to be non-irritating to skin if the mean tissue viability is greater than 50% following a 1 hour exposure. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25mg
- Concentration (if solution): applied unchanged
VEHICLE : test article applied unchanged
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30uL
- Concentration (if solution): applied unchanged
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30uL
- Concentration (if solution): applied unchanged - Duration of treatment / exposure:
- 1 hour
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- three
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Lot K02007
- Value:
- 96
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Lot W90402
- Value:
- 101
- 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:
- Rosin acid derivative was found to be non-irritating in a GLP-compliant, OECD Guideline 439 study.
- Executive summary:
The skin irritation potential of rosin acid derivative was assessed in a GLP-compliant, OECD 439. The test substance was applied to EpiDerm Reconstructed Human Epidermic (RhE) tissue unchanged for a 1 hour exposure. DPBS was used as a negative control and 5% SDS was used as positive control. The tissues were washed with DPBS and analyzed with an MTT assay. The percent tissue viability of the two lots were 96% and 101%. Based on the OECD Guideline 439 prediction model, rosin acid derivative is not irritating to the skin.
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