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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study is classified as reliable with restrictions because it is based on a read across approach, but it is an acceptable well-documented publication which meets basic scientific principles and follows a protocol comparable to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay).

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
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
no
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
N-hexane
EC Number:
203-777-6
EC Name:
N-hexane
Cas Number:
110-54-3
Molecular formula:
C6H14
IUPAC Name:
hexane
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 sensitising.
Executive summary:

This study was done to determine the concentration of hexane that would be expected to cause sensitisation 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 sensitisation in the LLNA test. The EC3 value for hexane was determined to be > 100% concentration. The test substance is therefore not sensitising.