Abstract
The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) has evaluated the data for zinc diamyldithiocarbamate [15337-18-5] to derive an occupational exposure limit value (maximum concentration at the workplace, MAK value) considering all toxicological end points. Relevant studies were identified from a literature search and also unpublished study reports were used. Zinc diamyldithiocarbamate does not lead to specific systemic toxicity, presumably due to low levels of uptake. Irritating effects induced by zinc diamyldithiocarbamate are only minimal, thus an oral study can be used to derive a maximum concentration at the workplace (MAK value). A combined study investigating reproductive toxicity and repeated dose toxicity that was carried out with rats according to OECD Test Guideline 422 determined a NOAEL of 85 mg/kg body weight and day after oral administration. This dose has been scaled to a MAK value of 10 mg/m(3) I (inhalable fraction). Exposure to the inhalable fraction results in gastrointestinal exposure via mucociliary clearance, reducing peak concentrations. Therefore, the substance has been assigned to Peak Limitation Category II with an excursion factor of 8. Similar to the findings after exposure to white mineral oil, inhalation of the aerosol of the poorly water-soluble zinc diamyldithiocarbamate may lead to lung overload, inflammatory reactions and microgranulomas. To prevent these overload effects, a MAK value of 5 mg/m(3) has been derived for the respirable fraction in analogy to white mineral oil and Peak Limitation Category II with an excursion factor of 4 has been set. There are no prenatal teratogenicity studies with zinc diamyldithiocarbamate. Therefore, zinc diamyldithiocarbamate has been assigned to Pregnancy Risk Group D. The substance is not genotoxic in vitro; there are no in vivo data. No carcinogenicity studies have been carried out. There is no evidence that zinc diamyldithiocarbamate has sensitizing potential. Skin contact is not expected to contribute significantly to systemic toxicity.