Registration Dossier
Registration Dossier
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EC number: 847-991-3 | CAS number: 90278-32-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Feb 13, 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- Preliminary study to determine the solubility of the test item
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: KeratinoSens™, EURL ECVAM DB-ALM Protocol No. 155, July 1st, 2015
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Gesundheit und Verbraucherschutz, Freie Handelsstadt Hamburg
- Type of study:
- activation of keratinocytes
Test material
- Reference substance name:
- trans-4-propyl-4''-(trifluoromethyl)-1,1',2,2',3,3',4,5,6,6'-decahydro[1,1':4',1''-terphenyl]
- EC Number:
- 847-991-3
- Cas Number:
- 90278-32-3
- Molecular formula:
- C₂₂H₂₉F₃
- IUPAC Name:
- trans-4-propyl-4''-(trifluoromethyl)-1,1',2,2',3,3',4,5,6,6'-decahydro[1,1':4',1''-terphenyl]
- Test material form:
- solid: crystalline
Constituent 1
In vitro test system
- Details on the study design:
- According to OECD 442D, the KeratinoSens test method is applicable to the testing of chemicals that are soluble or form a stable dispersion, either in water or DMSO.
The preliminary test (testing of the test material for solubility or suitability in the assay) was thus carried out with water and DMSO.
Results and discussion
In vitro / in chemico
Results
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: solubility screening
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- other: insoluble in test solutions
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The test item appeared to be insoluble in the required concentration in water. The test item was insoluble in DMSO at the required stock solution concentration of 200 mM and formed no stable suspension after addition of treatment medium. Since the KeratinoSens assay is not suitable for test items which precipitate into non stable suspensions or emulsions (defined by OECD 442D) the assay has to be considered as being technically impossible.
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