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. 2021 Dec 1;113(20):1484-1511.
doi: 10.1002/bdr2.1963. Epub 2021 Oct 23.

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

John M DeSesso  1   2 , Stephen B Harris  3 , Anthony R Scialli  4 , Amy Lavin Williams  1
Affiliations

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

John M DeSesso et al. Birth Defects Res. .

Abstract

Introduction: Quaternary ammonium compounds (QUATs) are commonly found in cleaning products, disinfectants, hand sanitizers, and personal care products. They have been used for >50 years 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.

Methods: A 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 Review of titles and abstracts found eight relevant studies, including two dissertation chapters; to these, 10 unpublished, guideline-compliant developmental and reproductive toxicity (DART) studies of QUATs (alkyldimethylbenzylammonium chloride [ADBAC] and dialkyldimethylammonium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.

Results: Six 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 mg QUATs/kg/day (mice), but these results were inconsistent. The reliable studies tested exposures ≥100 mg/kg/day (rats) with no effects.

Conclusions: The available weight of evidence indicates no adverse DART effects after QUATs exposures at anticipated concentrations and normal use.

Keywords: ADBAC; BAC; DDAC; NTDs; QAC; benzalkonium chloride; development; neural tube defects; reproduction.

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FIGURE 1
PRISMA 2020 flow diagram to describe culling of literature (Page et al., 2021)
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References

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