Registration Dossier
Registration Dossier
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EC number: 242-833-4 | CAS number: 19139-31-2
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Not P and not vP based on: readily biodegradable
DIHEXYL FUMARATE undergoes 89 % biodegradation after 29 days (88 % after 28 days) in the test conditions. Biodegradation starts on day 1 and reaches 68 % at the end of the 10-day window (days 1 to 11).
Not B and not vB based on: BCF ≤ 2,000 L/kg
predicted BCFs:
CAESAR (VEGA) - 45 L/kg
KNN (VEGA) - 43 L/kg
MEYLAN (VEGA) - 214 L/kg
BCFBAF v3.01 (EPISuite) - 216 L/kg (predicted logKow:6.12)
BCFBAF v3.01 (EPISuite) - 815 L/kg (measured logKow:7.00)
Not T based on:
EC10 or NOEC ≥ 0.01 mg/L for marine / freshwater organisms (long-term toxicity)
Several studies conducted in fish, daphnia and algae identified no EC50 results at the maximum loading rate achievable in the studies. No long term studies were availalbe.
and substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008
The overall conclusion from the available mutagenicity studies suggests the material should not be classified. The 422 screening study identified NOAEL of 1000 mg/kg bw.
and no other evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008
The 422 screening study identified NOAEL of 1000 mg/kg bw. The acute studies identified LD50 values of > 5000mg/kg bw
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