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Toxicological information

Skin sensitisation

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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:
1998
Bibliographic source:
Food and Chemical Toxicology 36(4):327 - 33

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed

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