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Toxicological information

Skin sensitisation

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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The protocoll used was the basis of the OECD Guideline 429 LLNA. However, it is a probably a non-GLP study with minor deviations to the OECD Guideline

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Structure activity relationships in skin sensitization using the murine local lymph node assay
Author:
J. Ashby, D.A. Basketter, D. Paton, I. Kimber
Year:
1995
Bibliographic source:
Toxicology, 103, 177-194
Reference Type:
secondary source
Title:
ICCVAM Evaluation of the Murine Local Lymph Node Assay
Author:
Karen E. Haneke, Raymond R. Tice, Bonnie L. Carson, Barry H. Margolin and William S. Stokes
Year:
2001
Bibliographic source:
Regulatory Toxicology and Pharmacology 34, 274-286

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
minor
Principles of method if other than guideline:
Method was according to Kimber and Basketter 1992
GLP compliance:
not specified
Remarks:
probably non-GLP
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Nonanoyl chloride, no further data

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no details given

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
5, 10, 25 %
No. of animals per dose:
not reported
Details on study design:
RANGE FINDING TESTS:
no details reported


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: a stimulation index ≥ 3, together with consideration of dose-response


TREATMENT PREPARATION AND ADMINISTRATION:
Groups of mice are exposed daily, for 3 consecutive days, to various concentrations of the test chemical or to the relevant vehicle alone, on the dorsum of both ears. Subsequently on 5 days following the initiation of exposure, mice are injected intravenously with [3H]thymidine and activity measured as a function of isotope incorporation in draining auricular lymph nodes (Kimber and Basketter, 1992).
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Concentration 5, 10, 25 Stimulation Index 12.7, 19.4, 20.9
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: not reported

Applicant's summary and conclusion

Executive summary:

Groups of mice are exposed daily, for 3 consecutive days, to various concentrations of the test chemical or to the relevant vehicle alone, on the dorsum of both ears. On day 5 following the initiation of exposure, mice are injected intravenously with [3H]thymidine and activity measured as a function of isotope incorporation in draining auricular lymph nodes (Kimber and Basketter, 1992). A stimulation index ≥ 3, together was observed in all concentration. Therfore nonanoylchlorid is regarded as sensitizing in the LLNA.

Due to the sturctural similarity the same result is expected for 2 -Ethyl-hexanoyl-chloride.