Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

DINP is not persistent (P) or very persistent (vP) based on standard test guideline results.

DINP is not bioaccumulative (B) or very bioaccumulative (vB) based on results from a fish dietary lab study, a food-web field study, and a calculated bioconcentration (BCF) factor.

The low water solubility and high Kowof DINP prevent conducting an aqueous exposure BCF study. However, there are sufficient data available fromstudies to conduct a weight-of-evidence assessment ofthe potential of DINP to bioconcentrate. A fish dietary bioaccumulation study demonstrated that DINP exhibited limited bioaccumulation based on a lipid normalized biomagnification factor (BMF or concentration ratio in tissue to that in diet) of <0.1 and rapid subsequent depuration with a tissue elimination half-life of <1 day (ExxonMobil Biomedical Sciences, Inc., 2002). Study results showed that lipid equivalent concentrations of DINP significantly declined with increasing trophic level and demonstrated a food-web magnification factor (FWMF) or trophic magnification factor (TMF) of 0.46(Mackintoshet al., 2004).

DINP is not toxic (T) based on results from chronic aquatic toxicity studies that show no effects at levels equal to or even exceeding its maximum water solubility and mammalian toxicity studies that support not classifying DINP as carcinogenic, mutagenic, toxic for reproduction, or assigning classifications of T, R48 or Xn, R48.