Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

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

PERSISTENCY (P) :

The test item has been demonstrated to be READILY Biodegradable in two OECD 301F studies and, in addition, in a SEPA 301F screening study. The OECD 301F studies attained 66% and 72% biodegradation by Day 28, and the SEPA 301F study attained 74%.

GR-50 -3010 / POMELOL is NOT P.

BIOACCUMULATION (B) :

The test item has an n-Octanol / Water partition coefficient of 3.4 (OECD 117) which is significantly inferior to the screening criteria of Log Pow of 4.5.

In silico modelling (BCFBAF (v3.01), BCF Baseline Model (v02.09)) predict the bioconcentration potential of the test item to be largely inferior to trigger levels of concern, and, in most cases, is predicted to be below a BCF of 100 L/kg.

Rapid metabolic turnover of the test item was observed in an In vitro metabolism study performed with Rainbow Trout S9 liver cells. An In vitro to In vivo model applied to the metabolic rate data predicts a BCF of < 100 L/kg.

GR-50-3010 / POMELOL is NOT B.

TOXICITY (T) :

An OECD 201 (Algal Inhibition) and OECD 202 (Acute Daphnia) GLP study has been performed on the test item. A non-guideline, non-GLP fish gill-cell assay has been conducted on Rainbow Trout gill cells as a means of determining the acute cytotoxicity to fish and the findings applied to a regression to extrapolate to an LC50 value.

The experimental results determined for the three different trophic levels of freshwater organisms are presented, below :

Algal Inhibition (OECD 201) :

72hr EC50(growth)       10.8 mg/L

72hr EC10(growth)       5.0 mg/L

72hr EC50(yield)            6.1 mg/L

72hr EC10(yield)              2.5 mg/L

NOEC                              1.02 mg/L

Acute Daphnia (OECD 202) :

48hr EC50 = 6.4 mg/L

Fish Gill Cell Assay (Rainbow Trout) :

LC50 = 4.71 mg/L

The test item demonstrates moderate acute toxicity to freshwater organisms. All EC/LC50 are between 4.7 and 10.6 mg/L.

GR-50 -3010 / POMELOL is NOT T.