Zinc bis(diethyldithiocarbamate)

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Predates GLP and OECD guidelines, minor restrictions, available as unpublished report

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

No method guideline specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Zinc bis(diethyldithiocarbamate)

EC Number:

238-270-9

EC Name:

Zinc bis(diethyldithiocarbamate)

Cas Number:

14324-55-1

Molecular formula:

C10H20N2S4Zn

IUPAC Name:

zinc bis(diethyldithiocarbamate)

Details on test material:

Name of test material (as cited in study report): Ethasan

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 50

Controls:

None

Route of administration:

dermal

Details on study design:

A series of fifteen alternate-day applications, 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 dimethylphthalate. This patch was placed on a predesignated site, covered, and sealed with overlapping strips of Blenderm tape. The patch was kept intact for twentyfour hours. At the end of 24 hours, the seal was broken and the patch removed. The skin sites were examined and gross 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 24 hours. The site was then re-examined to determine if any changes 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 48-hour rest period was permitted between removal and re-application of the test material.
After the fifteenth application, the participants were rested for two weeks before being challenged. The sites of contact used previously were challenged with the test material for 24 hours under occlusion. After removal of the patches, the sites were examined immediately and following at intervals of 24 and 48 hours.

Results and discussion

Results of examinations:

Skin changes accompanying application N°1 through 15:
Dose level 50%
No. with + reactions 1
Total no. in group 50
Clinical observations Slight erythema

Challenge
Dose level 50%
No. with + reactions 0
Total no. in group 50
Clinical observations None