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: current study according to OECD protocol and under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Norbornene
- Physical state: off-white solid
- Lot/batch No.: 119702
- Expiration date of the lot/batch: Feb. 2013
- date received: Oct, 1 2009
- Storage condition of test material: Fapprox. 4°C in the dark under Nitrogen

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
Source: Harlan Laboratories UK Ltd; Bicester, Oxon, UK
Age at start of study: 8-12 weeks
Weight at start of study: 15 - 23 g
Housing: individually in susended solid floor polypropylene cages
Diet and Water:ad libitum
temperature: 19 - 25°C
humidity: 30 - 70%
acclimitisation period: >= 5d

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
50%; 25%; 10% + control (vehicle)
No. of animals per dose:
4
Details on study design:
Range Finding Test:
compund solubility: soluble in acetone/olive oil 4:1 at 50% (w/w).
no signs of irritation or systemic toxicity at 50% (w/w) during observation period (day 1-6 post dose)

Main Study
Days 1-3: 25 µl of test solution were applied each day to the dorsal surface of each ear. The test material was applied with an automatic pipette and spread over the dorsal surface of the ear using the tip of the pipette. Each concentration group and the control group were treated in the same manner.
Days 4 and 5: no treatment
Day 6: All mice were injected with 250 µl phosphate buffered saline containing 3H-methyl thymidine, giving a total of 20 µCi to each mouse.
5 hours after application the animal were killed.
The lymph nodes of ech group were pooled for further treatment.
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 1 below for test substance. In a separate experiment for the positive controol, the stimulation index for 15%(v/v) of hexyl cinnamic aldehyde in acetone/olive oil 4:1 was determined. The S.I. was 3.70.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see table 1 below

Any other information on results incl. tables

Table 1

  concentration dpm  dpm/node S.I.  Result 
vehicle  (acetion/olive oil 4:1)  16706,59  2088,32  n.a.  n.a.  
10%   10183,23  1272,9  0,61  negative
 25%  8534,56  1066,81  0,51  negative
 50%  16334,21  2041,78  0,98  negative

dpm: disintegrations per minute

S.I: Stimulation Index

n.a. not applicable

clinical observations and mortality: There were no death and no signs of systemic toxicity noted in the test or control group animals during the test. Body weight changes of the test anmal between day 1 and 6 were comparable to those observed with the control group animals during the same period.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
the test-substance is a non-sensitizer under the conditions of the test.
Executive summary:

the test substance was applied in concentrations of 10, 25 and 50%. The observed S.I. were 0,61, 0,51 and 0,98 for each of the concentrations. The positive control showed an S.I. of 3.7. A S.I. of 3 is considered as the threshold for a positive response.

Conclusion: The test substance is non-sensitizing under test conditions.