Registration Dossier
Registration Dossier
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EC number: 204-677-5 | CAS number: 124-07-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Strategies for Identifying False Positive Responses in Predictive Skin Sensitization Tests
- Author:
- Basketter, D.A. et al.
- Year:
- 1 998
- Bibliographic source:
- Food and Chemical Toxicology 36(4):327 - 33
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:
- Octanoic acid
- EC Number:
- 204-677-5
- EC Name:
- Octanoic acid
- Cas Number:
- 124-07-2
- Molecular formula:
- C8H16O2
- IUPAC Name:
- octanoic acid
1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- not specified
Study design: in vivo (LLNA)
- Vehicle:
- not specified
- Concentration:
- 10, 25 and 50%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Irritation: in a human 4 h patch test (Basketter et al., 1997) octanoic acid showed a high irritation potential (68% of the panel responded to octanoic acid and 58% of the panel reacted to 25% sodium lauryl sulphate (positive control))
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by β-scintillation
- Criteria used to consider a positive response: Evaluation criteria used were taken from Kimber and Basketter (1992)
TREATMENT PREPARATION AND ADMINISTRATION: 25 µL of the test or vehicle alone was applied to the dorsum of both ears. The application was repeated on days 2 and 3. On day 6, 20 µCi 3H-methyl thymidine in 250 µL phosphate buffered saline (PBS) was injected into the tail vein. 5 h later, the draining auricular lymph nodes were excised and pooled for each experimental group. A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation and washed twice in PBS. After the final wash, pellets were resuspended in 5% trichloracetic acid (TCA) and incubated at 4 °C for 18 h. Pellets were resuspended in TCA and thymidine incorporation was measured. - Positive control substance(s):
- other: analogue tests with other substances are also reported
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- 10% test substance
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 25% test substance
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- 50% test substance
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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