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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study published in a peer-reviewed literature, using the standard method; brief reporting, but acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Strategies for identifying false positive responses in predictive skin sensitization tests
Author:
Basketter DA, Gerberick GF, Kimber I
Year:
1998
Bibliographic source:
Food and Chemical Toxicology, 36, 327-333

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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
Type:
Constituent
Details on test material:
No data are provided.

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
not specified
Details on test animals and environmental conditions:
No data are provided.

Study design: in vivo (LLNA)

Vehicle:
not specified
Concentration:
50% and 100%
No. of animals per dose:
4/dose
Details on study design:
Groups of 4 mice were treated with 25 μl of test material on the dorsum of both ears. Treatment was performed once daily for 3 consecutive days. Five days following the initiation of exposure all mice were injected via the tail vein with 250 μl phosphate buffered saline containing 20 μC tritiated thymidine. Mice were killed 5 hours later and the draining lymph nodes excised and pooled for each experimental group. A single cell suspension of lymph node cells is prepared by mechanical disaggregation, washed twice in excess of PBS, then precipitated with 5% trichloroacetic acid at 4 ˚C for 18 hr. Pellets were resuspended in trichloroacetic acid and incorporation of tritiated thymidine was measured by β-scintillation counting.
Positive control substance(s):
not specified

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: For 50% solution: 1.2 For 100% test substance: 1.6

Applicant's summary and conclusion