Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

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

PERSISTENCY:

The chemical substance has been demonstrated to be READILY Biodegradable (80% biodegradation by Day 28) and fulfiling the 10-day window criterion (29% biodegradation on Day 5, 71% on Day 15) under GLP conditions in an OECD 301F biodegradation screening study performed under conservative test conditions.

CONCLUSION - FOLIONE is NOT P /vP.

BIOACCUMULATION:

The n-Octanol/Water Partition Coefficient of the chemical substance has been determined in an OECD 117 study, under GLP, to have a LogPow = 3.0, and, thus, does not meet the B / vB screening criteria (LogPow > 4.5).

CONCLUSION - FOLIONE is NOT B / vB.

TOXICITY:

The toxicity of the chemical substance has been tested against the two trophic levels prescribed for testing under Annex VII - Algal Inhibition (OECD 201) and Acute Daphnia Toxicity (OECD 202) under GLP.

Algal Inhibition (OECD 201) - ErC50 (72 hr) = 0.79 mg/L; ErC10 (72 hr) = 0.20 mg/L; NOErC (72 hr) = 0.063 mg/L; NOEbC (72 hr) = 0.012 mg/L.

Acute Daphnia (OECD 202) - EC50 (48 hr) = 0.62 mg/L

The chemical substance does not fulfill any of the criteria for T (EC50 < = 0.1 mg/L; NOEC < = 0.01 mg/L)

CONCLUSION - FOLIONE is NOT T.

SUMMARY - FOLIONE is NOT P, NOT B, NOT T