Registration Dossier
Registration Dossier
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EC number: 939-248-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July to December 2012
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate nr 2011/40 on july 19th 2011
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- PROCESS OIL
- IUPAC Name:
- PROCESS OIL
- Test material form:
- gas under pressure: refrigerated liquefied gas
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 50%
- No. of animals per dose:
- Preliminary test: 2 females per dose
Main test: 4 females per dose
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Group 3 (vehicle) : / Group 4 (test item 1%) : 1.49 Group 5 (test item 2.5%) : 1.39 Group 6 (test item 5%) : 2.74 Group 7 (test item 10%) : 2.98 Group 8 (test item 25%) : 4.3 Group 9 (HCA 25%) : 9.29
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Group 3 (vehicle) : 1312 Group 4 (test item 1%) : 1954 Group 5 (test item 2.5%) : 1823 Group 6 (test item 5%) : 3598 Group 7 (test item 10%) : 3908 Group 8 (test item 25%) : 5642 Group 9 (HCA 25%) : 12187
Applicant's summary and conclusion
- Interpretation of results:
- ambiguous
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of the study, the test item, OIL T279, gave a positive result in the murine Local Lymph Node Assay, indicative of skin sensitization properties.
According to the EC3 value obtained, 10.23%, the test item should be considered as a weak sensitizer.
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