Tetramethylthiuram monosulphide

Sensitisation data (human)

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

Test material information

Constituent 1

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.