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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
Study period:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because there was no GLP statement provided, and limited data on methods were reported, but the study seemed to be well-conducted.

Data source

Reference
Reference Type:
publication
Title:
Use of the local lymph node assay for the estimation of relative contact allergenic potency
Author:
Basketter, DA, Blaikie, L, Dearman, RJ, Kimber, I, Ryan, CA, Gerberick, GF, Harvey, P, Evans, P, White, IR, and Rycroft, RJG
Year:
2000
Bibliographic source:
Contact Dermatitis, 42, 344-348

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
no
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): hexane

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Statistics:
Results were given in terms of the EC3 value, the concentration of the substance which is expected to cause a 3-fold increase in proliferative activity. EC3 values were determined based on results of previous LLNA tests for the test substance.

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: EC3 > 100%

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Concentrations of up to 100% of test substance are not expected to be sensitizing.
Executive summary:

This study was done to determine the concentration of hexane that would be expected to cause sensitization in humans. Results of previous LLNA experiments were used to calculate the EC3 value, the concentration at which the test substance would produce a 3 -fold increase in the proliferative activity of lymph nodes in the LLNA test. The 3 -fold increase is considered a positive response for sensitization in the LLNA test. The EC3 value for hexane was determined to be > 100% concentration. The test substance is therefore not sensitizing.