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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 it is an acceptable well-documented publication which meets basic scientific principles.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of 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: This study is classified as reliable with restrictions because it is an acceptable well-documented publication which meets basic scientific principles.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
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)
Species:
mouse
Strain:
not specified
Sex:
not specified
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.
Key result
Parameter:
EC3
Value:
> 3
Test group / Remarks:
Concentrations up to 100%
Remarks on result:
other: EC3 > 100%
Parameter:
SI
Test group / Remarks:
Test concentration 1
Remarks on result:
not measured/tested
Remarks:
The study report refers to 3 concentrations but does not provide specifics on the same. Results refer only to the single highest concentration which is reported as the EC3 value being >100%.
Parameter:
SI
Test group / Remarks:
Test concentration 2
Remarks on result:
not measured/tested
Remarks:
The study report refers to 3 concentrations but does not provide specifics on the same. Results refer only to the single highest concentration which is reported as the EC3 value being >100%.
Parameter:
SI
Test group / Remarks:
Test concentration 3
Remarks on result:
not measured/tested
Remarks:
The study report refers to 3 concentrations but does not provide specifics on the same. Results refer only to the single highest concentration which is reported as the EC3 value being >100%.
Interpretation of results:
other: Not sensitising
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.

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)

Resultsopen allclose all
Key result
Parameter:
EC3
Value:
> 3
Test group / Remarks:
Concentrations up to 100%
Remarks on result:
other: EC3 > 100%
Parameter:
SI
Test group / Remarks:
Test Concentration 1
Remarks on result:
not measured/tested
Remarks:
The study report refers to 3 concentrations but does not provide specifics on the same. Results refer only to the single highest concentration which is reported as the EC3 value being >100%.
Parameter:
SI
Test group / Remarks:
Test Concentration 2
Remarks on result:
not measured/tested
Remarks:
The study report refers to 3 concentrations but does not provide specifics on the same. Results refer only to the single highest concentration which is reported as the EC3 value being >100%.
Parameter:
SI
Test group / Remarks:
Test Concentration 3
Remarks on result:
not measured/tested
Remarks:
The study report refers to 3 concentrations but does not provide specifics on the same. Results refer only to the single highest concentration which is reported as the EC3 value being >100%.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitising
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.