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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
bis(2-ethylhexyl) fumarate
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
bis(2-ethylhexyl) fumarate
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).