Registration Dossier
Registration Dossier
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EC number: 800-760-0 | CAS number: 68139-89-9
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: according to guideline, GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- The sample measurement was one day later than planned due to a technical reason. This deviation was considered not to adversely affect the results or integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- (9E)-11-(2,5-dioxooxolan-3-yl)octadec-9-enoic acid; (9E,11E)-13-(2,5-dioxooxolan-3-yl)octadeca-9,11-dienoic acid; 8-(7-hexyl-1,3-dioxo-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)octanoic acid
- EC Number:
- 800-760-0
- Cas Number:
- 68139-89-9
- Molecular formula:
- Not applicable ( a generic molecular formula cannot be provided for this specific UVCB substance). Molecular weight approximated based on constituents (for the purpose of CHESAR calculations).
- IUPAC Name:
- (9E)-11-(2,5-dioxooxolan-3-yl)octadec-9-enoic acid; (9E,11E)-13-(2,5-dioxooxolan-3-yl)octadeca-9,11-dienoic acid; 8-(7-hexyl-1,3-dioxo-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)octanoic acid
- Test material form:
- other: liquid
- Details on test material:
- 100% purity
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Age of animals at starting: 11 weeks old (age-matched, within one week)
Body weight range at starting: 20.9+22.6 grams
Acclimatization time: at least 5 days
Only healthy animals
12 hours daily lighting
T: 22+-3°C
Relative humidity: 30-70%
Ventilation: 15-20 air exchanges/hour
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary Irritation/Toxicity test: 50, 25, 10, 5% (w/v) in AOO
Main test: 10, 5, 2.5% (w/v) in AOO - No. of animals per dose:
- 4 animals per dose (+ positive, negative control)
- Details on study design:
- Each animal was dosed once a day for 3 days (Days, 1, 2, 3). No treatment on days 4, 5 and 6.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- /
Results and discussion
- Positive control results:
- induced sensitisation
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: negative control: 1.0 10% w/v: 85.1 5% w/v: 37.3 2.5% w/v: 26.7 Positive control: 22.9
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: negative control: 1245.5 10% w/v: 106047.5 5% w/v: 46422.5 2.5% w/v: 33193.5 Positive control: 28474.5
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present assay, PETASAN, tested in a suitable vehicle, was shown to have sensitisation potential (sensitizer) in the LLNA.
- Executive summary:
The aim of this study was to determine the skin sensitisation potential of PETASAN following dermal exposure. The study was performed with mice as no in vitro alternative is available. The minimum number of animals was used.
Test item was tested for formulation compatibility in acetone:olive oil 4:1 (v:v).
Preliminary test were performed using four doses: 52, 25, 10 and 5% (w/v). 10%(w/v) was selected as top dose for main test.
The test item solutions were applied on the dorsal surface of ears of experimental animals for 3 days (Days 1, 2, 3). No treatment on day 4, 5, 6. On day 6, cell proliferation in LLN was measured. No mortality of systemic clinical signes were observed.
The substance was shown to have sensitisation potential (sensitizer) in LLNA.
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