Pigment Yellow 12, Pigment Yellow 13, Pigment Yellow 83
MAK Value Documentation – Translation of the German version from 2021
Andrea Hartwig1 (Chair of the Permanent Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area, Deutsche Forschungsgemeinschaft)MAK Commission2
1 Institute of Applied Biosciences, Department of Food Chemistry and Toxicology, Karlsruhe Institute of Technology (KIT), Adenauerring 20a, Building 50.41, 76131 Karlsruhe, Germany
2 Permanent Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area, Deutsche Forschungsgemeinschaft, Kennedyallee 40, 53175 Bonn, Germany
Abstract
The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) summarized and evaluated the data for Pigment Yellow 12 [6358-85-6], Pigment Yellow 13 [5102-83-0] and Pigment Yellow 83 [5567-15-7] to derive a 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 Relevant studies were identified from a literature search and also unpublished study reports were used. The pigments are mainly used as colourants in inks, cosmetics and industrial paints and varnishes. Depending on their intended use, the pigments are produced in different sizes with a d50 ranging from 15 to 250 nm. In technical applications, particles smaller than 100 nm are called nanoparticles. By definition, pigments are not soluble in application media. Pigment Yellow 12, 13 and 83 were found to be insoluble in the body and in phagolysosomal solution in vitro, which simulates the lung environment. The carcinogenic 3,3′-dichlorobenzidine was not released. Systemic toxicity was not observed in oral studies in rats and mice with exposure periods of up to 2 years. Therefore, these 3 pigments are insoluble and not bioavailable. If inhaled, insoluble particles can accumulate in the lung. In two 5-day inhalation studies of Pigment Yellow 83 and two 21-day inhalation studies of Pigment Yellow 13 in rats, local effects in the lungs were observed, which were similar to those observed after exposure to granular biopersistent dusts. No long-term inhalation toxicity studies have been carried out with the pigments. Long-term exposure to pigment concentrations which exceed the lung clearance capacity is assumed to result in particle-induced carcinogenic effects in the lungs. Therefore, in analogy to granular biopersistent dusts, Pigment Yellow 12, 13 and 83 have been classified in Carcinogen Category 4. A maximum concentration at the workplace (MAK value) has been established in analogy to that for granular biopersistent dusts taking into account the lower agglomerate density of particles below 100 nm. This results in a MAK value of 0.3 mg/m3 × (mass density of the pigment × 0.5). In analogy to granular biopersistent dusts, the pigments have been assigned to Peak Limitation Category II with an excursion factor of 8. No developmental toxicity studies are available for Pigment Yellow 12, 13 and 83. In analogy to granular biopersistent dusts, and based on the findings of two developmental toxicity studies with orally applied nanoparticles, titan dioxide and amorphous silica, which did not induce any effects on the foetus, Pigment Yellow 12, 13 and 83 have been assigned to Pregnancy Risk Group C. As the pigments are not soluble or bioavailable, genotoxicity and mutagenicity were not observed. The pigments are not sensitizing to the skin or airways and do not penetrate the skin in toxicologically relevant amounts.
