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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
This test 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.
GLP compliance:
no

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

Method

Type of population:
general
Subjects:
Patch testing of 50 human volunteers with TMTM 
Clinical history:
The criteria for qualifying were : general well-being, absence of any visible skin disease which might be confused whin skin reactions from the test material, willingness to cooperate, dependability and interlligence in following directions, reading, understanding, and signing an informed-consent statement.
Controls:
no
Route of administration:
dermal
Details on study design:
Size of patch = 3 cm x 3 cm.
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.
A lintine disc was moistened with the test material, prepared at 50% w/v in dimethylphtalate. This patch was placed on a predesignated site, covered, and sealed with overlapping strips of Blenderm tape. The patch was kept intact for twenty-four hours, the seal was broken and the patch removed. The skin sites were examined and changes, if present, were graded on a scale of 1 to 4. Absence of any visible skin changes was assigned a 0 value. After the patch was removed, the site was rested for 24h. The site was the re-examined to determine of any change had occurred since the previous examination. If the contact site manifested no change, the test material was re-applied to the same site. If significant irritation (2+ or greater) was observed, the investigator, at his discretion, had the option of either resting the individual or of applying the test material to a new site for the next contact period. This cycle was repeated in this manner on mondays, Wednesdays and Fridays. On weekends, a 48h rest period was permitted between removal and re-application of the test material.
After the fifteen application, the participants were rested for two weeks before being challenged. The sites of contact used previously were challenged with the test material for 24h under occlusion. After removal of the patches, the sites were examined immediately and following at intervals of 24h and 48h.

Results and discussion

Results of examinations:
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 capable of sensitizing 5 out of 50 individuals.

Applicant's summary and conclusion

Conclusions:
It was concluded that TMTM is a cumulative irritant and a sensitizing agent.
Executive summary:

This test 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 capable of sensitizing 5 out of 50 individuals.