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)
Rationale for reliability incl. deficiencies:
other: GLP study according to EU/OECD-guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
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:
acetone/olive oil (4:1 v/v)
Concentration:
50, 25 and 10 % (w/v) in AOO
No. of animals per dose:
twenty-five female CBA/J Rj mice were allocated to five groups of five animals each
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: The stimulation index values were 1.87, 2.98 and 3.11 at concentrations of 50, 25 and 10 % (w/v), respectively.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see table

Any other information on results incl. tables

 Test Group Name  Animal No  DPM  Stimulation Index
 Negative control (AOO)  1  386.5  1.00
   2  276.5  
   3  321.5  
   4  529.5  
   5  325.5  
 50 % (w/v) in AOO  347.5  1.87
   7  950.5  
   8  1335.5  
   9  521.5  
   10  280.5  
 25 % (w/v) in AOO  11  1626.5  2.98
  12  382.5  
   13  1482.5  
   14  1292.5  
   15  706.5  
 10 % (w/v) in AOO  16  1933.5  3.11
   17  1319.5  
   18 1143.5   
   19  674.5  
   20  650.5  
 Positive control (25 % HCA) in AOO  21  1833.5  15.74
   22  3812.5  
   23  9031.5  
   24  11063.5  
   25  3205.5  

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, under the conditions of the present assay the test item was shown to have a weak sensitization potential (sensitizer) in the Local Lymph Node Assay.