Registration Dossier
Registration Dossier
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EC number: 245-605-2 | CAS number: 23356-96-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
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)
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- L-(pyrrolidin-1-yl)methanol
- EC Number:
- 245-605-2
- EC Name:
- L-(pyrrolidin-1-yl)methanol
- Cas Number:
- 23356-96-9
- Molecular formula:
- C5H11NO
- IUPAC Name:
- L-(pyrrolidin-1-yl)methanol
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- unchanged (no vehicle)
- Concentration:
- 10%
- No. of animals per dose:
- 4
- Details on study design:
- 25 µL of treatment was applied on the dorsum of both ears on Day 1, 2, 3.
Lymphocyte subpopulations of the draining lymph nodes are studied by flow cytometry. Evaluation is based on the ratio of T cells to B cells (CD3:CD19). This ratio is an indicator of the B cell proliferation induced by the treatment of mice with contact allergens. If the T cells to B cells ratio is below 4, the tested compound is considered as a sensitizer. - Positive control substance(s):
- other: DNCB
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- other: Ratio CD3/CD19
- Value:
- ca. 6.4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- With PROL, the CD3/CD19 ratio was higher than 4. Thus, PROL is not a sensitiser. It does not require labelling with any classification.
- Executive summary:
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