Registration Dossier
Registration Dossier
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EC number: 202-777-3 | CAS number: 99-66-1
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 with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- Evaluation is based on the ratio of T cells to B cells (CD3:CD19).
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Valproic acid
- IUPAC Name:
- Valproic acid
- Details on test material:
- - Lot/batch No.: 7M00030
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:
- 25 μL to the dorsum of both ears on day 1, day 2 and day 3.
- No. of animals per dose:
- 4 animals/group
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: other: See "any other information on results".
- Parameter:
- SI
- Remarks on result:
- other: No data. Evaluation is based on the ratio of T cells to B cells (CD3:CD19)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: no data
Any other information on results incl. tables
|
Concentration (%) |
CD3 (%) |
CD19 (%) |
R = CD3 : CD19 |
DNCB in A/O |
0.5 |
72.5 |
25.8 |
2.81 |
Acetone/Olive oil (A/O) |
|
91.3 |
7.0 |
13.04 |
Valproic acid |
25 |
90.4 |
8.5 |
10.64 |
With Valproic acid, the CD3:CD19 ratio was higher than 4. The test article had no sensitizing activity.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Valproic acid is not a sensitizer. It does not require labeling with any risk phrase.
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