Registration Dossier
Registration Dossier
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EC number: 245-674-9 | CAS number: 23460-76-6
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:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Sensitizers induce primary proliferation of lymphocytes in the lymph node draining the application site. The LLNA assesses this proliferation. The 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 ratio of T cells to B cells is below 4, the test article is considered as a sensitizer.
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 21-hydroxypregna-4,9(11),16-triene-3,20-dione 21-acetate
- EC Number:
- 245-674-9
- EC Name:
- 21-hydroxypregna-4,9(11),16-triene-3,20-dione 21-acetate
- Cas Number:
- 23460-76-6
- Molecular formula:
- C23H28O4
- IUPAC Name:
- 2-[(3aS,3bS,9aS,11aS)-9a,11a-dimethyl-7-oxo-3H,3aH,3bH,4H,5H,7H,8H,9H,9aH,11H,11aH-cyclopenta[a]phenanthren-1-yl]-2-oxoethyl acetate
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 mice/group
- Positive control substance(s):
- other: dinitrochlorobenzene
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- other: CD3/CD19 ratio
- Value:
- > 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dehydrocortinene is not a skin sensitizer. It does not require labeling with any classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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