Registration Dossier
Registration Dossier
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EC number: 695-906-1 | CAS number: 1256753-06-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26.02.-18.03.2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- trans-2-[4'-[difluoro(3,4,5-trifluorophenoxy)methyl]-2,3',5'-trifluoro[1,1'-biphenyl]-4-yl]-5-butyl-1,3-dioxane
- EC Number:
- 695-906-1
- Cas Number:
- 1256753-06-6
- Molecular formula:
- C27H22F8O3
- IUPAC Name:
- trans-2-[4'-[difluoro(3,4,5-trifluorophenoxy)methyl]-2,3',5'-trifluoro[1,1'-biphenyl]-4-yl]-5-butyl-1,3-dioxane
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst
- Age at study initiation: Pre-test: 9-10 weeks; Main test: 8 - 9 weeks
- Weight at study initiation: Pre-test: 20.5 g; Main test: 19.5+/- 1.5 g
- Housing: grouped per dose
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 6
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25 and 50 % (w/w)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 50% in acetone/olive oil (4+1, v/v)
- Irritation: slight erythema
- Lymph node proliferation response: -
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: Stimulation index > 3 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Standard statistical methods have been applied for data processing.
Results and discussion
- Positive control results:
- Conc. SI
0%: 1.00
5% 1.8
10% 3.2
25% 5.8
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.84
- Test group / Remarks:
- Test Group: 10%
- Key result
- Parameter:
- SI
- Value:
- 0.74
- Test group / Remarks:
- Test Group: 25%
- Key result
- Parameter:
- SI
- Value:
- 0.77
- Test group / Remarks:
- Test Group: 50%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was not a skin sensitiser under the test conditions of this study.
- Executive summary:
In the study the test item formulated in acetone/olive oil was assessed for its possible skin sensitising potential. For this purpose a local lymph node assay was performed using test item concentrations of 10, 25 and 50% (w/w).
In this study Stimulation Indices (S.I.) of 0.84, 0.74 and 0.77 were determined with the test item at concentrations of 10, 25 and 50% (w/w) in acetone/olive oil, respectively.
The test item was not a skin sensitiser under the test conditions of this study.
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