Registration Dossier
Registration Dossier
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EC number: 811-523-6 | CAS number: 88992-45-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 luciferase KeratinoSens™ test method)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- An internal standard Operating Procedure (SOP) is in place with technical steps record, critical steps observed by a second senior member. Data analysis and storage performed with in-house LIMS system.
- Type of study:
- ARE-Nrf2 luciferase KeratinoSens™ test method
- Justification for non-LLNA method:
- In vitro method required since 2017
Test material
- Reference substance name:
- {2-hydroxy-3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfanyl]propyl}trimethylazanium chloride
- EC Number:
- 811-523-6
- Cas Number:
- 88992-45-4
- Molecular formula:
- C14 H19 F13 N O S . Cl
- IUPAC Name:
- {2-hydroxy-3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfanyl]propyl}trimethylazanium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): NS-4000
- Appearance: Off-white powder (determined by WIL Research Europe)
- Storage condition of test material: At room temperature desiccated
Constituent 1
In vitro test system
- Details of test system:
- Keratinoses transgenic cell line [442D]
- Details on the study design:
- Incubation time: 48h
Concentrations (μM): 0.977, 1.95, 3.91, 7.81, 15.6, 31.3, 62.5, 125, 250, 500, 1000, 2000
Replicates per concentration: 3
Cell model: KeratinoSens
Vehicle: Water
MW: 532.0
KeratinoSens vehicle SD: 13% (passed), 14% (passed), 12% (passed) - Vehicle / solvent control:
- water
- Negative control:
- other: sodium dodecyl sulfate
- Positive control:
- cinnamic aldehyde [442D]
Results and discussion
- Positive control results:
- Sensitizing Potential MR (Imax) MR (μM)
KeratinoSens 1 Yes (+) Calc. EC1.5 (μM): 33.2 14.3 128
Calc. EC2 (μM): 46.3
Calc. EC3 (μM): 65.8
KeratinoSens 2 Yes (+) Calc. EC1.5 (μM): 3.99 5.35 64
Calc. EC2 (μM): 14.3
Calc. EC3 (μM): 36.2
KeratinoSens 3 Yes (+) Calc. EC1.5 (μM): 18.4 11.2 128
Calc. EC2 (μM): 37.9
Calc. EC3 (μM): 65.5
In vitro / in chemico
Resultsopen allclose all
- Key result
- Group:
- test chemical
- Run / experiment:
- run/experiment 3
- Parameter:
- EC 1.5 [442D]
- Value:
- 15.6 µM
- Cell viability:
- IC30 = 21.2 µM
- Vehicle controls validity:
- valid
- Key result
- Group:
- test chemical
- Run / experiment:
- run/experiment 2
- Parameter:
- EC 1.5 [442D]
- Value:
- 15.6 µM
- Cell viability:
- IC30 = 25.9 µM
- Vehicle controls validity:
- valid
- Key result
- Group:
- test chemical
- Run / experiment:
- run/experiment 3
- Parameter:
- EC 1.5 [442D]
- Value:
- 15.6 µM
- Cell viability:
- IC30 = 16.9 µM
- Vehicle controls validity:
- valid
- Outcome of the prediction model:
- negative [in vitro/in chemico]
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material CAS 88992-45-4 is not a skin sensitizer
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