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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

Not P:

  • Dioctyl fumarate is inherently biodegradable (48.8 % in 28 days)

Not B:

  • Although DOF has a high log Pow value (7.9), dioctyl fumarate does not show bioaccumulation; in a bioaccumulation study with fish the BCF was 243.

Not T:

  • NOEC (fish) = 0.3 mg/L (> 0.01 mg/L)
  • Bacterial reverse mutation test (Ames test), OECD 471: not mutagenic. In vitro chromosome aberration test, OECD 472: not clastogenic. In vitro mammalian cell gene mutation test, OECD 476: not mutagenic
  • The repeated dose toxicity (90-day) study showed a NOEAL (oral, rat) of > 1000 mg/kg bw/day, and there was no indication of reproduction toxic effects (extra histopathology on reproductive organs).