Dibutyl methylenedithiodi(acetate)

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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

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)

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

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)

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)

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Migrated from Short description of key information:
MBTester is a non sensitizing agent.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Justification for selection of respiratory sensitisation endpoint:
No data

Justification for classification or non-classification

On the basis of the test result no classification is necessary.