Department of Toxicology, Faculty of Pharmacy, Ankara University, Tandoğan, 06100, Ankara, Turkey.
Department of Toxicology, Faculty of Pharmacy, Hacettepe University, Sıhhiye, 06100, Ankara, Turkey.
Arch Toxicol. 2018 Oct;92(10):3051-3059. doi: 10.1007/s00204-018-2296-7. Epub 2018 Aug 25.
Boric acid and sodium borates are currently classified in the EU-CLP regulation as "toxic to reproduction" under "Category 1B", with hazard statement of H360FD. However, so far field studies on male reproduction in China and in Turkey could not confirm such boron-associated toxic effects. As validation by another independent study is still required, the present study has investigated possible boron-associated effects on male reproduction in workers (n = 212) under different boron exposure conditions. The mean daily boron exposure (DBE) and blood boron concentration of workers in the extreme exposure group (n = 98) were 47.17 ± 17.47 (7.95-106.8) mg B/day and 570.6 ± 160.1 (402.6-1100) ng B/g blood, respectively. Nevertheless, boron-associated adverse effects on semen parameters, as well as on FSH, LH and total testosterone levels were not seen, even within the extreme exposure group. With this study, a total body of evidence has accumulated that allows to conclude that male reproductive effects are not relevant to humans, under any feasible and realistic conditions of exposure to inorganic boron compounds.
硼酸和硼酸钠目前在欧盟 CLP 法规中被归类为“生殖毒性”，属于“类别 1B”，危害说明为 H360FD。然而，迄今为止，中国和土耳其的男性生殖系统领域研究未能证实硼相关的毒性作用。由于仍需要另一项独立研究进行验证，本研究调查了在不同硼暴露条件下，工人（n=212）中硼对男性生殖系统可能产生的影响。极端暴露组（n=98）工人的平均日硼暴露（DBE）和血硼浓度分别为 47.17±17.47（7.95-106.8）mg B/天和 570.6±160.1（402.6-1100）ng B/g 血液。然而，即使在极端暴露组中，也未观察到硼对精液参数以及 FSH、LH 和总睾酮水平的不良影响。通过这项研究，积累了大量证据，可以得出结论，在任何可行和现实的接触无机硼化合物的情况下，硼对男性生殖系统的影响与人类无关。
