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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 February 2018 to ****
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

1
Chemical structure
Reference substance name:
Reaction mass of tris(dipentyldithiocarbamato-S,S')antimony and [bis(2-ethylhexyl)dithiocarbamato-S,S']bis(dipentyldithiocarbamato-S,S')antimony and bis[bis(2-ethylhexyl)dithiocarbamato-S,S'](dipentyldithiocarbamato-S,S')antimony and tris[bis(2-ethylhexyl)dithiocarbamato-S,S']antimony
EC Number:
948-063-1
IUPAC Name:
Reaction mass of tris(dipentyldithiocarbamato-S,S')antimony and [bis(2-ethylhexyl)dithiocarbamato-S,S']bis(dipentyldithiocarbamato-S,S')antimony and bis[bis(2-ethylhexyl)dithiocarbamato-S,S'](dipentyldithiocarbamato-S,S')antimony and tris[bis(2-ethylhexyl)dithiocarbamato-S,S']antimony
Test material form:
liquid: viscous
Specific details on test material used for the study:
-Purity: >99%
-Description: Clean amber viscous liquid
-Storage: Room temperature in the dark

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
The animals were housed in suspended solid floor polypropylene cages with stainless steel mesh lids and furnished with softwood flakes bedding (Datesand Ltd., Cheshire, UK).

Free access to tap water and food (2014C Teklad Certified Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.

The temperature and relative humidity were set to achieve limits of 19 to 25 C and 30 to 70%, respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darknes

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
Preliminary results indicate test item was a viscous liquid that was too viscous to dose as undiluted. The maximum feasible dose was the test item at concentration of 50% v/v in acetone/olive oil 4:1. Test concentrations of 50%, 25% or 10% v/v in acetone/olive oil 4:1 were selected for the study.
No. of animals per dose:
5
Details on study design:
The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per animal and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
The test item will be regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non sensitizer".
Statistics:
Data was processed to give group mean values for disintegrations per minute and standard deviations where appropriate.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
1.28
Test group / Remarks:
10% Concentration (% v/v) in acetone/olive oil 4:1
Key result
Parameter:
SI
Value:
1.45
Test group / Remarks:
25% Concentration (% v/v) in acetone/olive oil 4:1
Key result
Parameter:
SI
Value:
2.66
Test group / Remarks:
50% Concentration (% v/v) in acetone/olive oil 4:1

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was considered to be a non-sensitizer under the conditions of the test.
Executive summary:

The test item is not a skin sensitizer according to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures and the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS).