Registration Dossier

Administrative data

Description of key information

Zinc bis(diethyldithiocarbamate) (ZDEC) is included in Annex I of EU Directive 67/548/EEC as irritating to skin, eyes and respiratory tract (Xi, R36/37/38). Available studies on eye irritation confirm this classification. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Zinc bis(diethyldithiocarbamate) (ZDEC) is included in Annex I of EU Directive 67/548/EEC as irritating to skin, eyes and respiratory tract. Therefore the performance of additional skin and eye irritation studies is not required in accordance with Column 2 of REACH Annex VII. The available studies on eye irritation, although predating GLP and OECD guidelines and having some restrictions in design and reporting, generally confirm this conclusion. The study of Pharmacology Research, Inc., 1977, reported the conjunctivae becoming severely inflammated (average score 3 at 24 + 48 + 72 hours observation timepoints) and moderately swollen (average chemosis score 1 at 24 + 48 + 72 hours observation timepoints). Areas of corneal opacity became visible at 72 hours and persisted through 7 days observation period (average scores 1-2). Similar findings were reported in the study of TNO, 1976b. 24 hours after the test substance has been brought into the eyes, slight corneal damage and slight iritis were observed in 4 out of 6 rabbits. Moderate or severe conjunctivae damage was observed in all rabbits. In the course of the 7 days observation period these eye lesions recovered partly.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Zinc bis(diethyldithiocarbamate) (ZDEC) is included in Annex I of EU Directive 67/548/EEC as skin, eye and respiratory tract irritant (Xi, R36/37/38). In accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, it should be classified as Category 2, H315 (causes skin irritation), H319 (causes serious eye irritation) and STOT - single exposure, Category 3, H335 (may cause respiratory irritation).