Registration Dossier
Registration Dossier
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EC number: 610-428-5 | CAS number: 486406-09-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 13 - June 08, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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:
- 4-Ethyl-2',3'-difluor-4''-propyl-1,1':4',1''-terphenyl
- EC Number:
- 605-092-1
- Cas Number:
- 157248-25-4
- Molecular formula:
- C₂₃H₂₂F₂
- IUPAC Name:
- 4-Ethyl-2',3'-difluor-4''-propyl-1,1':4',1''-terphenyl
- Test material form:
- solid: bulk
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: 8-12 weeks
- Weight at study initiation: 20.1 +/- 1.6 g
- Housing: single
- 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: 25 and 50 %
- Irritation: No
- 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
TREATMENT PREPARATION AND ADMINISTRATION: - 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 % 1.78
10 % 2.54
25 % 4.88
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.26
- Test group / Remarks:
- Test Group: 10 %
- Key result
- Parameter:
- SI
- Value:
- 0.91
- Test group / Remarks:
- Test Group: 25 %
- Key result
- Parameter:
- SI
- Value:
- 0.65
- Test group / Remarks:
- Test Group: 50 %
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- The test item was not a skin sensitiser under the test conditions of this study.
- Executive summary:
The informtion for this endpoint study record was obtained form an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 429. The test item was not a skin sensitiser under the test conditions of this study.
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