Registration Dossier
Registration Dossier
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EC number: 203-836-6 | CAS number: 111-12-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Methyl oct-2-ynoate
- EC Number:
- 203-836-6
- EC Name:
- Methyl oct-2-ynoate
- Cas Number:
- 111-12-6
- Molecular formula:
- C9H14O2
- IUPAC Name:
- methyl oct-2-ynoate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/diethylphthalate
- Concentration:
- A volume of approximately 25 ul of 0.05, 0.1, 0.25, 0.5 or 1.0% w/v test material in 1:3 ethanol/diethylphthalate (vehicle) was applied topically to the dorsum of each ear lobe (left and right) on three consecutive days.
- No. of animals per dose:
- 4
- Details on study design:
- Animals were divided into 6 groups consisting of 4 animals in each group. Animals were 8-12 weeks of age. Groups included 1 control (vehicle) group and 5 test groups.
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- EC3
- Value:
- 0.45
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Executive summary:
Under the conditions of the study, Folione in 1:3 EtOH:DEP is a potential skin sensitizer with an EC3 value of 0.45% (112.5 ug/cm2).
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