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Description of key information

A skin sensitisation test (EU Method B6, GLP compliant) was performed and the substance was considered to be not sensitising to the skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Guideline study performed in compliance with GLP, available as unpublished report, no restrictions, fully adequate for assessment.
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
84/448/EEC, Annex V, B.6
GLP compliance:
yes
Type of study:
split adjuvant test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
25% (w/w) in milli-RO water Concentration of test material and vehicle used for each challenge:
50%, 25%, 5% and 0% (w/w)
Concentration / amount:
Concentration of test material and vehicle used at induction: 25% (w/w) in milli-RO water Concentration of test material and vehicle used for each challenge: 50%, 25%, 5% and 0% (w/w)
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction:
None

Evidence of sensitisation of each challenge concentration:
None

Other observations:
Red spots (signs of irritation were observed in 3 test
animals at concentrations 50% (24 and 48 hrs), 25% (48 hrs)

and 0% (48 hrs) respectively and in one control animal (48

hrs). No signs of systemic toxicity were observed in any of
the animals during the study period.

Interpretation of results:
GHS criteria not met
Conclusions:
The results indicate a sensitization rate of 0%. It is therefore improbable that the test substance has sensitizing properties.
Applying the general Classification and labelling requirements for dangerous substances as laid down in Annex VI of the EEC Council Directive 67/548/EEC, the test substance need not be labelled as a skin sensitizer.
Executive summary:

Tetrabenzylthiuram disulfide (TBzTD) was tested in the Split Adjuvant Test to determine its sensitizing potential.

Adult female guinea pigs (Dunkin-Hartley strain) were induced by epicutaneous applications of the test substance, 25% (w/w) in Milli-RO water. After being challenged with a series of test substance concentrations (50%, 25% and 5%) in Milli-RO water, no positive response (grade 2 or more) was observed to the concentrations tested in any of the animals.

These results indicate a sensitization rate of 0%. It is therefore improbable that the test substance has sensitizing properties.

Applying the general classification and labelling requirements for dangerous test substance as laid down in Annex VI of the EEC

Council Directive 67/548/EEC the test substance need not be labelled as a skin sensitizer.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Tetrabenzylthiuram disulfide (TBzTD) was tested in the Split Adjuvant Test (EU Method B6 and GLP) to determine its sensitizing potential. Twenty adult female guinea pigs (Dunkin-Hartley strain) were induced by epicutaneous applications of the test substance, 25% (w/w) in Milli-RO water. After being challenged with a series of test substance concentrations (50%, 25% and 5%) in Milli-RO water, no positive response (grade 2 or more) was observed to the concentrations tested in any of the animals. These results indicate a sensitization rate of 0%. It is therefore improbable that the test substance has sensitizing properties.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of skin sensitisation test, the substance does not need to be classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

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