Is Boric Acid Toxic to Reproduction in Humans? Assessment of the Animal Reproductive Toxicity Data and Epidemiological Study Results
2016
Boric acid and sodium borates are classified as toxic to reproduction in the CLP Regulation
under “Category 1B” with the hazard statement of “H360FD”. This classification is based on the reprotoxic
effects of boric acid and sodium borates in animal experiments at high doses. However, boron mediated reprotoxic
effects have not been proven in epidemiological studies so far. The epidemiological study performed in Bandirma
boric acid production plant is the most comprehensive published study in this field with 204 voluntarily participated male
workers. Sperm quality parameters (sperm morphology, concentration and motility parameters), FSH, LH and testosterone
levels were determined in all participated employees as the reproductive toxicity biomarkers of males. However, boron
mediated unfavorable effects on reproduction in male workers have not been determined even in the workers under very
high daily boron exposure (0.21 mg B/kg-bw/day) conditions. The NOAEL for rat reproductive toxicity is equivalent to a
blood boron level of 2020 ng/g. This level is higher than the mean blood boron concentration (223.89 ± 69.49 ng/g) of the
high exposure group workers in Bandirma boric acid production plant (Turkey) by a factor of 9. Accordingly, classifying
boric acid and sodium borates under “Category 1B” as “presumed reproductive human toxicant in the CLP regulation
seems scientifically not reasonable. The results of the epidemiological studies (including the study performed in China)
support for a down-classification of boric acid from the category 1B, H360FD to category 2, H361d, (suspected of damaging
the unborn child).
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