Registration Dossier
Registration Dossier
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EC number: 215-355-9 | CAS number: 1323-42-8
Skin sensitisation
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Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Remarks:
- sumamry
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar 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
- Test material form:
- solid
- Remarks:
- soft waxy solid or gel
- Details on test material:
- Melting point of 82 deg C; also reported as 75-77 deg C. Crystallizes from alcohol (ethanol). UV absorption maximum at 295 nm. Additional impurity reports: polyvinyl stearate, up to 2.0% (CASRN not reported, but may be 9003-95-6).
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Purity 86%
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 10, 25, 50%
- No. of animals per dose:
- 5
- Details on study design:
- Test material in DMSO was applied to the dorsal surface of each ear of the mice, daily for 3 days. On day 5, tritiated thymidine (3HTdR) was administered via the tail vein.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- EC3
- Value:
- 16
- Remarks on result:
- other: positive
- Remarks:
- Sensitiser. value units are % TM in vehicle
Any other information on results incl. tables
None of the animals died, and there were no signs of toxicity. The EC3 value was calculated to be 16%. Hydroxystearic acid was considered a sensitiser.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test substance (12-HSA) was tested in an LLNA using tritiated thymidine in female CBA mice. The results were positive, and 12-hydroxystearic acid was considered a sensitiser. The EC3 value was calculated to be 16%. This summary data reflects the opinion of the CIR Expert Panel that the data are valid and informative, adding to a weight of evidence approach for the sensitisation potential of the test substance.
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