Carbon black should not be classified as a human carcinogen based on rodent bioassay data

Numerous epidemiology studies have failed to adequately demonstrate an increased risk of lung cancer due to occupational exposure to carbon black (CB). CB is not carcinogenic to mice (oral, skin or inhalation), hamsters (inhalation or intratracheal), guinea pigs (inhalation), rabbits (skin or inhalation), primates (skin or inhalation) or rats (oral). Only studies conducted by inhalation and intratracheal administration in rats have shown significant increases in benign and malignant lung tumors and lesions described as benign cystic keratinizing squamous-cell (KSC) tumors. CB-induced lung tumor formation, including KSC lesions, occurs only in rats. An expert panel reviewing KSC lesions (induced in rats by TiO2 or p-aramid) concluded that KSC lesions are not seen in humans. Lung tumors in humans are primarily located in the bronchial airways, whereas in the rat they occur in the parenchyma and are alveolar in origin. This species-specific response (tumor formation and KSC lesions) by the rat to CB, not seen in any other laboratory species and which has not been reported in humans, strongly suggests that the results of the rat inhalation bioassay should not be considered directly relevant when assessing human risk. Therefore, CB should not be classified as carcinogenic to humans based on the rodent bioassay data.