Registration Dossier
Registration Dossier
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EC number: 948-946-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of bis(2-ethylhexyl) adipate and cyclohexyl 2-ethylhexyl adipate and dicyclohexyl adipate
- EC Number:
- 948-946-1
- Molecular formula:
- C20H36O4, C18H30O4, C22H42O4
- IUPAC Name:
- Reaction mass of bis(2-ethylhexyl) adipate and cyclohexyl 2-ethylhexyl adipate and dicyclohexyl adipate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 30869
- Expiration date of the lot/batch: 2019-01-31
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Skin model: API-200
Supplier: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- other: MTT reduction control
- Amount/concentration applied:
- 30µl
- Duration of treatment / exposure:
- 1h total (25min at room temperature and 35 minutes in the incubator)
- Duration of post-treatment incubation (if applicable):
- The tissues were incubated in the incubator at 37°C for 24 ± 2 hours. After 24 ± 2 hours, the tissues were transferred into new 6-well plates pre-filled with 0.9 mL fresh medium and placed into the incubator for an additional 18 ± 2-hour post-incubation period.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 107
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The substance is considered not to require classification as a skin irritant, if the mean tissue viability exceeds 50%.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results observed and by applying the evaluation criteria, it was concluded that Reaction mass of Hexanedioic acid, 1-cyclohexyl 6-(2-ethylhexyl) ester, Hexanedioic acid, 1,6-dicyclohexyl ester and Hexanedioic acid, 1,6-bis(2-ethylhexyl) ester does not show a skin irritation potential in the EpiDermTM in vitro skin irritation test under the test conditions chosen.
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