Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2010
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2008
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Version / remarks:
2003
Principles of method if other than guideline:
In this modified LLNA study the index of lymph node weight and cell-count were used as relevant endpoints and the ear swelling measured (index of the ear weight) was used as an additional parameter to assess the irritant potential of the test item. The validity of this modified LLNA had been shown in an interlaboratory validation study:

Ehling G, Hecht M, Heusener A, Huesler J, Gamer AO, van Loveren H, Maurer Th, Riecke K, Ullmann L, Ulrich P, Vandebriel R and Vohr H-W, An European inter-laboratory validation of alternative endpoints of the murine local lymph node assay: 1st round, Toxicology 212, 60-68, 2005A
Ehling G Hecht M, Heusener A, Huesler J, Gamer AO, van Loveren H, Maurer Th, Riecke K, Ullmann L, Ulrich P, Vandebriel R and Vohr H-W, An European inter-laboratory validation of alternative endpoints of the murine local lymph node assay: 2nd round, Toxicology 212, 69-79, 2005B
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
other: cell count index
Value:
1.32
Test group / Remarks:
test substance (0.5%)
Parameter:
other: cell count index
Value:
2.24
Test group / Remarks:
test substance (5%)
Parameter:
other: cell count index
Value:
1.72
Test group / Remarks:
test substance (50%)
Parameter:
SI
Test group / Remarks:
test substance (0.5%)
Remarks on result:
not measured/tested
Parameter:
SI
Test group / Remarks:
test substance (5%)
Remarks on result:
not measured/tested
Parameter:
SI
Test group / Remarks:
test substance (50%)
Remarks on result:
not measured/tested

Applicant's summary and conclusion