Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. QA statement)
Remarks:
See certificate in report
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Reference substance name:
864970-33-2
Cas Number:
864970-33-2
IUPAC Name:
864970-33-2

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
other: ethanol/distilled water 7:3
Concentration:
3 groups: 25%; 10% and 5%
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: A stimulation index of less than 3 was recorded for thge three concentrations of the test material.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: See below loaded picture

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
The organic part of PACTT, 2 Na is not classified as sensitising for skin. As the mineral part of PACTT, 2 Na, Sodium Bromide, is not either classified as sensitising for skin (published general information on list number 231-599-9) , it can be concluded that the multi-constituent substance has not to be classified as sensitising for skin.