Peculiarities of toxic effects produced by diisononyl phthalate and regulation over it in polymer materials and medical products
V.A. Hrynchak, S.I. Sychik
Scientific Practical Centre of Hygiene, 8 Akademicheskaya Str., Minsk, 220012, Belarus
We chose diisononyl phthalate as our experimental research object; this compound is an isononyl ester of phthalic acid based on n-butene (CAS No. 28553-12-0).
Our research goal was to establish peculiarities and regularities related to toxic effects produced by diisononyl phthalate on experimental animals’ bodies and give scientific substantiation for fixing its permissible quantities that could migrate from polymer materials and medical products.
We accomplished our research applying a set of toxicological, physiological, hematologic, biochemical, immunologic, cy-togenetic, morphological, organoleptic, sanitary-chemical, and statistical techniques. We were the first to establish peculiarities of toxic impacts exerted by diisononyl phthalate after intragastric introduction into white rates. Those impacts were dose-dependent toxic effects produced both on a whole body and specific organs and systems with typical disorders in functional and morphological parameters, cell differentiation, and an increase in number of cells with changes in their genetic apparatus.
We revealed that overall toxic effects as well as specific damaging ones produced by diisononyl phthalate on the endocrine and reproductive systems in experimental animals’ bodies became apparent via functional disorders in the thyroid gland and gonads, embryogenesis, and offspring post-natal development. A chronic experiment allowed us to determine quantitative regularities and how toxic effects produced by diisononyl phthalate manifested themselves; so we were able to determine limiting parameters and a biological marker as well as fix a threshold of its hazardous impacts on a body, and substantiate fixing permissible quantities that could migrate from polymer materials and medical products. Our experiment results gave grounds for creating a hygienic standard for diisononyl phthalate that provided hygienic assessment and safe distribution of materials and medical products made of polymers that contained the compound.
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