Systematic assessment of quaternary ammonium compounds for the potential to elicit developmental and reproductive effects.

Abstract

INTRODUCTION\nQuaternary ammonium compounds (QUATs) are commonly found in cleaning products, disinfectants, hand sanitizers, and personal care products. They have been used for >50\u2009years and are considered safe when used according to directions. Recent papers report reduced fertility and neural tube defects in rodents after low-level exposures. To determine if QUATs interfere with mammalian reproduction and development, we conducted a methodical assessment of all available data.\n\n\nMETHODS\nA systematic literature search identified 789 potential articles. Review of titles and abstracts found eight relevant studies, including two dissertation chapters; to these, 10 unpublished, guideline-compliant developmental and reproductive toxicity (DART) studies of QUATs (alkyldimethylbenzylammonium chloride [ADBAC] and dialkyldimethylammonium chloride [DDAC]) were added. ToxRTool was utilized to evaluate all 18 studies for data quality.\n\n\nRESULTS\nSix studies were scored as reliable without restriction ; four studies were considered reliable with restriction (mainly due to small rabbit group sizes). No test article-related, adverse DART endpoints were reported in these studies. ToxRTool scored the remaining eight studies as not reliable. The unreliable studies failed to fully describe methods and/or endpoints, did not quantify (and in some cases, did not verify) exposures, utilized non-standard test methods, reported endpoints incorrectly, and assessed endpoints at inappropriate times. Some (not all) unreliable studies reported adverse effects after 7.5\xa0mg QUATs/kg/day (mice), but these results were inconsistent. The reliable studies tested exposures ≥100\u2009mg/kg/day (rats) with no effects.\n\n\nCONCLUSIONS\nThe available weight of evidence indicates no adverse DART effects after QUATs exposures at anticipated concentrations and normal use.