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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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.