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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

A test on guinea pigs was performed and showed that TMTM is a skin sensitizer in guinea pigs.
A reliable patch test on humans showed also the potential of skin sensitisation of TMTM.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
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.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
104 mg/ml (5M)
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
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%)
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Sensitisation Test on animals - Section 7.4 of IUCLID

The skin sensitising properties of TMTM were tested in guinea-pigs in an occlusive epicutaneous test (BG Chemie 1996). A single application of a 0.5M TMTM suspension in vaseline (=104 mg/ml) was used for indution, 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. According these results, TMTM was considered to be skin sensitizer in guinea pigs.

Sensitisation Tests on humans - Section 7.10.4 of IUCLID

A test (Monsanto 1976) was performed to determine if the test material is capable of irritating the skin of humans under controlled test conditions; and, if so, to classify the test material as a primary irritant, fatiguing agent and/or sensitizer on the basis of the visible clinical response. A group of 50 individuals who qualified was selected from a local population (US). Sites on the upper area of each individual were designated for contact with the test material. A series of fifteen alternate-day application, each of 24 hours duration were scheduled to be carried out. Patch testing of 50 human volunteers with TMTM (50% w/v in dimethylphthalate for 15 alternate-day applications, each of  24 hours) produced one positive reaction on initial application, 7 positive reactions during the course of 15 serial applications, and 5 positive reactions on a subsequent rechallenge (two weeks after the last  application). 

Under the test conditions, TMTM tested at 50% w/v in dimethylphtalate was able of sensitizing 5 out of 50 individuals.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

TMTM is already classified in the Annexe VI of CLP as skin sensitizer : Skin Sens. 1, H 317 (May cause an allergic skin reaction).

Based on the available data, it is not possible to determine a subcategorisation.