Registration Dossier
Registration Dossier
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EC number: 617-898-0 | CAS number: 866462-52-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June/July 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study was performed in compliance with the following regulations or guidelines:
• OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitization : Local Lymph Node Assay (adopted 22 July 2010)
° Method B42 Skin Sensitization (Local Lymph Node Assay) of Commission Regulation (EC) No. 440/2008
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 617-898-0
- EC Number:
- 617-898-0
- Cas Number:
- 866462-52-4
- Molecular formula:
- C17 H21 N O5
- IUPAC Name:
- 617-898-0
- Test material form:
- solid: particulate/powder
- Details on test material:
- Off white powder
Constituent 1
- Specific details on test material used for the study:
- Batch 866462-52-4
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- not specified
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 10%, 5% or 2.5% w/w
- No. of animals per dose:
- 4
- Details on study design:
- Following a preliminary screening test in which no clinical signs of toxicity were noted at the concentration of 10% w/w, this concentration was selected as th highest dose investigated in the main test of the LLNA.
Three groups, each of four animals, were treated with 50μL (25μL per ear) of the test item as a suspension in propylene glycol at concentrations of 10%, 5% or 2.5% w/w. A further group of four animals was treated with propylene glycol alone.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- ca. 2.92
- Variability:
- Negative
- Test group / Remarks:
- Concentration 2.5% in propylene glycol
- Parameter:
- SI
- Value:
- ca. 1.84
- Variability:
- Négative
- Test group / Remarks:
- Concentration 5% in propylene glycol
- Key result
- Parameter:
- SI
- Value:
- ca. 5.14
- Variability:
- Positive
- Test group / Remarks:
- Concentration 10% in propylene glycol
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test item was considered to be a sensitizer under the conditions of the test.
- Executive summary:
The test item was considered to be a sensitizer under the conditions of the test.
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