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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviwed journal

Data source

Reference
Reference Type:
publication
Title:
Structure activity relationships in skin sensitization using the murine local lymph node assay
Author:
J. Ashby et. al.
Year:
1995
Bibliographic source:
Toxicology 103 (1995)

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
The skin sensitizing potential of the test chemical was assessed by using the Mouse Local Lymph node Assay.
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
IUPAC name: 1-bromohexane
Mol. formula: C6H13Br
Molecular Weight: 165.073 gm/mol
Smiles: C(CCC)CCBr
InChI: 1S/C6H13Br/c1-2-3-4-5-6-7/h2-6H2,1H3

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (LLNA)

Vehicle:
other: AOO (Acetone/olive oil, 80/20 v/v)
Concentration:
5%, 10% and 25%
No. of animals per dose:
No data available
Details on study design:
No data available
Positive control substance(s):
not specified
Statistics:
No data available

Results and discussion

Positive control results:
No data available

In vivo (LLNA)

Resultsopen allclose all
Parameter:
other: T/C ratio
Value:
1.2
Test group / Remarks:
Concentration 5%
Remarks on result:
other: Not sensitizing
Parameter:
other: T/C ratio
Value:
1.4
Test group / Remarks:
Concentration 10%
Remarks on result:
other: Not sensitizing
Parameter:
other: T/C ratio
Value:
2.1
Test group / Remarks:
Concentration 25%
Remarks on result:
other: Not sensitizing
Cellular proliferation data / Observations:
No data available

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
The values for Stimulation Indices at various test concentrations were 1.2, 1.4 and 2.1 which are below 3, hence EC3 value couldnot be calculated. Therefore, the given test chemical was considered to be not sensitizing to skin of mice.
Executive summary:

The dermal sensitization potential of the given test chemical was evaluated in a mouse local lymphnode assay (LLNA). Groups mice were exposed topically on the dorsum of both ears to 5%, 10% and 25% of the test material or to an equal volume of relevant vehicle only. Treatment was performed daily for 3 consecutive days. Five days after the initiation of exposure, all mice were injected intravenously with [H3] thymidine and activity measured as a function of isotope incorporation in draining auricular lymph nodes. The approach to estimation of the relative skin sensitization potential was based on the mathematical estimation of the concentration of chemical necessary to obtain a threshold positive response (SI = 3); this is termed as the EC3 value. A substance was classified as a skin sensitizer if it induced a threefold or greater increase in local lymph node proliferative activity at one or more test concentrations when compared with concurrent vehicle-treated controls (SI≥3). The values for Stimulation Indices at various test concentrations were 1.2, 1.4 and 2.1 which are below 3, hence EC3 value couldnot be calculated. Therefore, the given test chemical was considered to be not sensitizing to skin of mice.