Registration Dossier

Diss Factsheets

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 and fulfiling the 10-day window criterion under GLP conditions in an OECD 301F biodegradation screening study performed under conservative test conditions.

CONCLUSION - FOLROSIA 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 = 2.7 and 2.8, and, thus, does not meet the B / vB screening criteria (LogPow > 4.5).

CONCLUSION - FOLROSIA 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) = 63 mg/L; ErC10 (72 hr) = 30 mg/L; NOErC (72 hr) = 9.3 mg/L; NOEbC (72 hr) = 2.8 mg/L.

Acute Daphnia (OECD 202) - EC50 (48 hr) = 42 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 - FOLROSIA is NOT T.

SUMMARY - FOLROSIA is NOT P, NOT B, NOT T.

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