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Toxicological information

Skin sensitisation

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Administrative data

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Guideline study performed in compliance with GLP, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
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.

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrakis(phenylmethyl)thioperoxydi(carbothioamide)
EC Number:
404-310-0
EC Name:
Tetrakis(phenylmethyl)thioperoxydi(carbothioamide)
Cas Number:
10591-85-2
Molecular formula:
C30H28N2S4
IUPAC Name:
tetrakis(phenylmethyl)thioperoxydi(carbothioamide)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Induction
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)
Challenge
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.

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