Registration Dossier
Registration Dossier
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EC number: 941-526-9 | CAS number: -
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)
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- The non-radioactive approach was chosen in accordance to OECD guideline 429: "...other endpoints (i.e.than radioactive) for assessment of the number of proliferating cells may be employed provided the Performance Standards requirements are fully met." In the paper by Ehling et al., Toxicology 212, 60-68 and 69-79 (2005) this method was validated in an inter-lab investigation.
A proliferation index and an ear weight index are determined allowing an estimation of the sensitising and the irritating potency of a test item. - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-{phenyl[2-(tetradecanoyloxy)phenyl]methyl}phenyl tetradecanoate
- EC Number:
- 941-526-9
- Molecular formula:
- C47H68O4
- IUPAC Name:
- 2-{phenyl[2-(tetradecanoyloxy)phenyl]methyl}phenyl tetradecanoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: particulates
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: Balb/c:AnCrl
- Sex:
- female
- Details on test animals and environmental conditions:
- strain: Balb/c:AnCrl
Study design: in vivo (LLNA)
- Vehicle:
- other: acetone/olive oil 5/1 v/v
- Concentration:
- 10%, 25% and 50% AVG-42/AOO
- No. of animals per dose:
- 6
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- In the LLNA assay alpha-Hexylcinnamaldehyde (HCA) was confirmed as a skin sensitiser.
Any other information on results incl. tables
The non-radioactive approach was used. AVG-42 showed no increase at concentrations of 10%, 25% and 50% AVG-42/AOO. Signicant increases of cells counts and lymph node weights at any concentration were not observed. The DI was <1 (non-skin sensitiser). AVG-42 was assessed as not sensitising in accordance to OECD guideline 429.
The reference item was clearly confirmed as a sensitiser.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In conclusion, AVG-42 was a non-sensitiser (not classified).
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