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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
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-Difluoroethanamine
EC Number:
671-709-6
Cas Number:
430-67-1
Molecular formula:
C2H5F2N
IUPAC Name:
2,2-Difluoroethanamine

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
concentrations of 100 % (undiluted), 50 and 25 % (w/v) in DMF
No. of animals per dose:
five groups of five animals each
Details on study design:
the negative control group received DMF
the positive control group received 25% (w/v) α-Hexylcinnamaldehyde (HCA) in DMF
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: see table
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see table

Any other information on results incl. tables

 Test Group Name  Animal Number  DPM  Stimulation Index
 Negative control (DMF)  1  423.5 1.0 
 2 183.5   
   3  208.5  
   4  255.5  
   5  162.5  
   100% (undiluted)  6  119.5  0.6
   7  132.5  
   8  189.5  
   9  111.5  
   10  210.5  
  50% (w/v) in DMF  11  62.5  0.5
 12  53.5  
   13  135.5  
   14  294.5  

 

 15

 88.5

 

 25% (w/v) in DMF

 16

 161.5

 1.0

   17  186.5  
   18  217.5  
   19  359.5  
   20  350.5  
 Positive control (25% HCA in DMF)  21  2999.5  11.5
   22  3060.5  
   23  3006.5  
   24  2265.5  
   25  2796.5  

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, under the conditions of the present assay was shown to have no sensitization potential (non-sensitizer) in the Local Lymph Node Assay.