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Maximum permissible concentrations and negligible concentrations for phthalates (dibutylphthalate and di(2-ethylhexyl)phthlate), with emphasis on endocrine disruptive properties

Maximaal toelaatbare risiconiveaus en verwaarloosbare risiconiveaus voor ftalaten

Publiekssamenvatting

In dit rapport zijn maximaal toelaatbare risiconiveaus (MTRs) en verwaarloosbare risiconiveaus (VRs) afgeleid voor dibutylftalaat en di-ethylhexyl-ftalaat. Ftalaten worden vaak verdacht van endocriene verstoring. Gegevens over endocriene en reproductieve verstoring door ftalaten zijn verzameld van in vitro en in vivo testen. Met name de twee-generatie reproductie studies blijken gevoelig om endocrien verstorende effecten te signaleren. Geen enkele van de testen met uterien gewicht als eindpunt (vaak in combinatie met vaginale cornificatie gemeten) liet positieve resultaten zien. Op basis van de beschikbare data is geconcludeerd dat de MTRs die afgeleid zijn op basis van klassiek gebruikte eindpunten (overleving, groei en reproductie) voor de geteste verbindingen voldoende bescherming bieden tegen endocrien verstorende effecten.

Synopsis

This report presents maximal permissible concentrations (MPCs) and negligible concentrations (NCs) are derived for di-n-butylphthalate (DBP) and di(2-ethylhexyl)phthalate (DEHP). Phthalates are often mentioned as suspected endocrine disrupters. Data with endpoints related to the endocrine or reproductive system for in vitro as well as in vivo tests were collected. Especially the two-generation reproduction studies were found sensitive in detecting endocrine disruptive effects. None of the tests with uterine weight (often in combination with vaginal cornification) showed positive results. The most sensitive endpoints in the in vivo studies are converted to concentrations in the organic carbon exerting adverse effects. Based on the available data, the MPCs derived using classical endpoints (survival, growth and reproduction) are concluded to give sufficient protection against adverse endocrine disruptive effects.
 

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