the weight of scientific evidence does not support an association between formaldehyde exposure alone and histopathological changes in human nasal mucosa. Although several studies have found changes, these cannot be associated with formaldehyde exposure alone and are confounded by other air contaminants. Boysenet al.(1990) found no significant histopathology differences in nasal mucosa of 37 workers and 37 controls exposed to 0.5 ppm to over 2 ppm of formaldehyde. Mutagenicity In vitro, formaldehyde is able to induce gene mutations and chromosomal aberrations in mammalian cells without (and also in presence of) external metabolic activation. DNA-protein crosslinks are a sensitive measure of DNA interaction by formaldehyde. In vivo, the overall evidence of available studies supports the conclusion that the genotoxic effects after exposure via relevant routes are limited to those cells which are in direct contact with
Toxic starting from 21 mg aniline/kg bw/day. c) Carcinogenicity Aniline is currently classified as carcinogenic, category 3 and labelled with R40 "limitedevidence of a carcinogenic effect". Animal studies have shown an increase in tumors of the spleen in rats exposed to aniline hydrochloride. EPA calculated an oral cancer slope factor of 5.7 x 10-3 (mg/kg/d) -1 and an oral unit risk estimate of 1.6 × 10- 7 (µg/L)-1. d) Genotoxicity and mutagenicity Aniline did not induce unscheduled DNA repair in primary human or rat hepatocytes. In mice, aniline induced micronuclei in several studies, but only at very high dose levels in the toxic range. Negative results have been found in the analysis of sperm head anomalies and equivocal results in the dominant lethal test. e) Other toxic effects, e.g. immunotoxicity and local toxicity - No information available. f) Ecotoxicity Toxic to aquatic organisms
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