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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Toxicological evaluation - Tetramethylthiruam monosulfide
Author:
BG Chemie
Year:
1996
Bibliographic source:
BG Chemie. Volume 10. page 91
Reference Type:
publication
Title:
Allergens in rubber products
Author:
Kantoh H., Ishihara M, Itoh M and Hosono K.
Year:
1985
Bibliographic source:
HIFU 27 501-509

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The skin sensitizing properties of tetramethylthiuram monosulfide were tested in guinea-pigs in an occlusive epicutaneous test.
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
An old and reliable study for skin sensitisation endpoint is available on the registered substance. The Registrant decided to use this study and to not perform a new study on animals.

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetramethylthiuram monosulphide
EC Number:
202-605-7
EC Name:
Tetramethylthiuram monosulphide
Cas Number:
97-74-5
Molecular formula:
C6H12N2S3
IUPAC Name:
N,N-dimethyl[(dimethylcarbamothioyl)sulfanyl]carbothioamide
Details on test material:
no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
104 mg/ml (5M)
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
10.4 or 104 mg/ml (0.5 or 5M)
No. of animals per dose:
12 animals per group
Details on study design:
no data
Challenge controls:
no data
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
5M + 0.5M
No. with + reactions:
3
Total no. in group:
12
Clinical observations:
(25%)
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
5M + 5 M
No. with + reactions:
9
Total no. in group:
12
Clinical observations:
(75%)

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
In this study, TMTM was sensitizing in 3 of 12 animals in the 0.5 M group and 9 of 10 animals in the 0.5 M group.
Executive summary:

The skin sensitising properties of TMTM were tested in guinea-pigs in an occlusive epicutaneous test. A single application of a 0.5M TMTM suspension in vaseline (=104 mg/ml) was used for induction, while the challenge treatment consisted of 0.05M (=10.4 mg/ml) or 0.5 M suspensions. The skin reactions were evaluated 72h after the beginning of the challenge treatment. TMTM was sensitizing in 3 of 12 animals in the 0.5 M group and 9 of 10 animals in the 0.5 M group.

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