Registration Dossier
Registration Dossier
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EC number: 610-847-3 | CAS number: 524709-77-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 18 - October 10, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22 July 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- updated 06 July 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-[3,5-difluoro-4-(trifluoromethoxy)phenyl]-3-fluoro-4'-[(1s,4r)-4-propylcyclohexyl]-1,1'-biphenyl
- EC Number:
- 610-847-3
- Cas Number:
- 524709-77-1
- Molecular formula:
- C28H26OF6
- IUPAC Name:
- 4-[3,5-difluoro-4-(trifluoromethoxy)phenyl]-3-fluoro-4'-[(1s,4r)-4-propylcyclohexyl]-1,1'-biphenyl
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc Postbus 6174 NL - 5960 AD Horst
- Age at study initiation: Pre-test and main study: 10 - 11 weeks
- Weight at study initiation: Pre-test: 21.0 and 21.7 g; Main test: 17.7 - 22.9 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 5
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 10, 25, and 50%. (w/w)
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 25 and 50 % in Methyl Ethyl Ketone
- Irritation: 50%: very slight erythema of the ear skin (Score 1) and scaly ears on day 6, 25%: very slight erythema of the ear skin (Score 1) on day 4
- Systemic toxicity: no signs of systemic toxicity
- Ear thickness measurements: No excessive increase in ear thickness or ear weights was recorded in the animals
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)
Results and discussion
- Positive control results:
- Conc. SI
10% 0.84
25% 1.35
50% 0.94
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.84
- Test group / Remarks:
- Test Group: 10 %
- Key result
- Parameter:
- SI
- Value:
- 1.35
- Test group / Remarks:
- Test Group: 25 %
- Key result
- Parameter:
- SI
- Value:
- 0.94
- 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:
The test item was not a skin sensitiser under the test conditions of this study.
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