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Registration Dossier
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EC number: 610-104-3 | CAS number: 43100-47-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-phenyl-5-(1,1,1-trifluoro-2-{6-hydroxy-5-phenyl-[1,1'-biphenyl]-3-yl}propan-2-yl)-[1,1'-biphenyl]-2-ol
- EC Number:
- 610-104-3
- Cas Number:
- 43100-47-6
- Molecular formula:
- C39 H29 F3 O2
- IUPAC Name:
- 3-phenyl-5-(1,1,1-trifluoro-2-{6-hydroxy-5-phenyl-[1,1'-biphenyl]-3-yl}propan-2-yl)-[1,1'-biphenyl]-2-ol
- Details on test material:
- - Name of the test substance used in the study report: Ligand TFME-DPP
- Test substance No.: 08/0260-1
- Purity: 94.8 g/100 g
- Homogeneity: homogeneous by visual inspection
- Storage stability: The stability under storage conditions over the study period was guaranteed by the manufacturer.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: 6 – 12 weeks
- Weight at study initiation: 18.1 g – 21.8 g
- Housing: single housed
- Diet: Kliba-Labordiät (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 14 days before the first test-substance application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24°C
- Humidity (%): 30 – 70%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Remarks:
- MEK was used as the vehicle because good homogeneity of the preparation was achieved.
- Concentration:
- 60%
- No. of animals per dose:
- 5
- Details on study design:
- Groups of 5 female CBA/J mice each were treated with a 60% w/w preparation of the test substance in MEK (methyl ethyl ketone) or with the vehicle alone. The 60% test-substance preparation was the maximum technically applicable concentration. The test-substance preparation was produced on a weight per weight basis shortly before the application by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. The homogeneity of the test-substance preparation during application was provided by stirring with a magnetic stirrer.
Each test animal was applied with 25 μL per ear of the test-substance preparation to the dorsum of both ears for three consecutive days. The control group was treated with 25 μL per ear of the vehicle alone.
Form of application: Suspension - Positive control substance(s):
- other: Alpha-Hexylcinnamaldehyde
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see table
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see table
Any other information on results incl. tables
Calculation of Stimulation Incices per Dose Group:
| 3H-thymidine incorporation | |||
| Test group | Treatment | [DPM/lymph node pair] | Stimulation Index |
| 1 | vehicle MEK | 553.6 | 1.00 |
| 2 | 60% in MEK | 1,205.2 | 2.18 |
When applied as 60% preparation in MEK, the test substance did not induce a biologically relevant response (increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5) in the auricular lymph node cell counts. There was no relevant increase in lymph node weights as well. Concomitantly, the increase of 3H-thymidine incorporation into the cells was not biologically relevant (increase above the cut off stimulation index of 3) at this concentration.
No signs of systemic toxicity were noticed.
The test-substance preparation caused a minimal increase in ear weights as indication of slight ear skin irritation. In addition test substance residues on the ears were observed in all animals on study days 1 and 2 and in two animals on the day of lymph node removal.
The expected body weight gain was generally observed in the course of the study.
No abnormalities were observed during general observation.
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