Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
other: ethanol/water 70/30
Concentration:
5 % , 10 %, 20 %
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value. In this study Stimulation Indices of 0.64, 1.23 and 1.10 were determined with the test item at concentrations of 5, 10, and 20% in ethanol:deionised water (70+30).
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Remarks:
Test item concentration % (w/v) Group Measurement DPM Calculation conc. DPM-BGa) number of lymph nodes DPM per lymph nodeb) 0 BG I 20 --- --- --- 0 BG II 23 --- --- --- 0 1 3727 3706 8 463.2 5 2 2395 2374 8 296.7 10 3 4576 4555 8 569.3 20 4 4108 4087 8 510.8

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information not classified