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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP certificate

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
acc. to 2004/73/EC
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibutyl methylenedithiodi(acetate)
EC Number:
238-289-2
EC Name:
Dibutyl methylenedithiodi(acetate)
Cas Number:
14338-82-0
Molecular formula:
C13H24O4S2
IUPAC Name:
butyl 2-({[(2-butoxy-2-oxoethyl)sulfanyl]methyl}sulfanyl)acetate
Test material form:
other: liquid
Details on test material:
Lot#: 20704
Assay GC-FID: 96.9 area%

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/CaBkl and CBA/CaOlaHsd
Sex:
female
Details on test animals and environmental conditions:
animals were house individually housed in PP cages with softwood woodflakes.
Acclimatisation period of 5 days
Free access to tap water and food (certified rat and mouse Diet) throuout the study
Temperature between 19 and 25°C, humidity between 30 and 70% rel.
Light cycle 12/12 h
Air exchange appr. 15 / h

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25 and 50% in vehicle, 100%
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
Sensitivity and reliability of the test was assessed by use of alpha-hexylcinammaldehyd which is known for a positive reaction in CBA mice. (Safepharm Study 0039/0944)

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: S.I < 1.45 for concentrated test material, conclusion: no stimulation
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Remarks:
Test mat conc dpm dpm/Node Stimulation index Result %v/v in vehicle 0 (vehicle) 6268.52 783.57 n.a. n.a. 25 6661.75 832.72 1.06 negative 50 9112.35 1139.04 1.45 negative 100 8885.62 1110.70 1.42 negative

Any other information on results incl. tables

The test item was assayed at three concentrations of 25, 50 and 100%.  

Each female mousewas treated by  topical application with the selected solution to entire dorsal surface  of each ear once daily over three consecutive days. Five days after the first topical application treatment all mice were  injected intravenous with 3H-methyl thymidine. 
Approximately 5 hours after 3H-methyl thymidine injection all mice were  sacrificed and the draining auricular lymph nodes were 
excised, in order  to prepare single cell suspension of the lymph node cells.

The 3 H-methyl thymidine-incorporation was measured in a Beckman LS6500 counter and  expressed as the number  of disintegrations per minute (DPM).  Determination of radioactivity was performed individually for each animal. The proliferation response of lymph node cells was calculated as the  ratio of 3H-methyl thymidine incorporation into lymph nodecells of test  group animals relative to that recorded for control group animals. A  stimulation index, ratio of test substance/vehiclecontrol, was  calculated for each concentration.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was considered to be a non-sensitizer under the conditions of the test.