Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: abstract or documentation insufficient for assessment or handbook

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Allergens in rubber products
Author:
Kantoh et al.,
Year:
1985
Bibliographic source:
HIFU (Skin Research), 27, 501-509 (1985)
Reference Type:
publication
Title:
Sensitisation by carbamate accelerators of rubber cure
Author:
Rudzki et al.,
Year:
1984
Bibliographic source:
Przeg: Derm., 121-125 (1984)
Reference Type:
publication
Title:
Sensitivity to some rubber additives
Author:
Rudzki, E. et al.
Year:
1976
Bibliographic source:
Contact Dermatitis 2, 24-27
Reference Type:
review article or handbook
Title:
Toxikologische Bewertung Zinkethylphenyl-dithiocarbamat Nr. 219
Author:
BG Chemie
Year:
1991
Bibliographic source:
Berufsgenossenschaft der chemischen Industrie, Toxikologische Bewertung, Ausgabe 05/91, Nr. 2019

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
Patch tests on patients with a contact dermatitis were conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc bis(N-ethyl-N-phenyldithiocarbamate)
EC Number:
238-677-1
EC Name:
Zinc bis(N-ethyl-N-phenyldithiocarbamate)
Cas Number:
14634-93-6
Molecular formula:
C18H20N2S4Zn
IUPAC Name:
zinc bis(N-ethyl-N-phenyldithiocarbamate)

Method

Type of population:
not specified
Subjects:
Patients with contact dermatitis.

Results and discussion

Results of examinations:
For the identification of allergens in rubber products a solution 1% zinc ethylphenyldithiocarbamate was examined in a patch test. Seventy-two hours after application on patients with a contact dermatitis caused by rubber, two out of 31 patients showed a positive reaction (Kantoh et al., 1985).

The sensitivity to some rubber additives was investigated by Rudzki et al. (1976). Within a group of 1203 patients only 0.08% reacted positive to zinc ethylphenyl dithiocarbamate.
In a further test the sensitising potential of zinc ethylphenyldithiocarbamate was tested on 2569 patients with an eczema. Hypersensitivity reactions to zinc ethylphenylcarbamate was found in less than 0.5% of the examined persons (Rudzki et al., 1984).

The BG Chemie (1991) concludes in their Toxicological Assessment that a potential skin sensitizing activity of zinc ethylphenyl dithiocarbamate in humans, based on the available experiences in rubber industry, seems to be relatively rare.

Applicant's summary and conclusion

Executive summary:

For the identification of allergens in rubber products a solution 1% zinc ethylphenyldithiocarbamate was examined in a patch test. Seventy-two hours after application on patients with a contact dermatitis caused by rubber, two out of 31 patients showed a positive reaction.

The sensitivity to some rubber additives was investigated by Rudzki et al. (1976). Within a group of 1203 patients only 0.08% reacted positive to zinc ethylphenyl dithiocarbamate.

In a further test for the examination of the sensitising potential of zinc ethylphenyldithiocarbamate was tested on 2569 patients with an eczema. Hypersensitivity reactions to zinc ethylphenylcarbamate was found in less than 0.5% of the examined persons (Rudzki et al.(1984).

The BG Chemie (1991) concludes in their Toxicological Assessment that a potential skin sensitizing activity of zinc ethylphenyl dithiocarbamate in humans, based on the available experiences in rubber industry, seems to be relatively rare.