Fenamiphos

PBT assessment

PBT assessment: overall result

Reference

Name:

Fenamiphos

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Reference substance:

Fenamiphos

PBT status:

the substance is not PBT / vPvB

Justification:

Considerations on P/vP properties

No study on ready biodegradability is available. For risk assessment purposes a conservative approach is taken and the test item is considered as not readily biodegradable (worst case). However, the metabolism of Fenamiphos was studied in two different water/sediment systems for a maximum of 100 days under aerobic conditions in the dark at 20 °C. The experiment was conducted in compliance with the GLP standards and in accordance with EC/SETAC test guidelines (please refer to IUCLID section 5.2.2). It was demonstrated that the substance is degraded and mineralised in aerobic water/sediment systems. The DT50 for freshwater sediment is expected to be 111 days. The DT50 for the freshwater phase is determined to be 7.9 days. Based on a study according to OECD TG 307 the DT50 (20 °C pF2/10kPa) of Fenamiphos was determined to be 0.71 days. The normalized geometric mean DT50 (20 °C pF2/10kPa) values of its metabolites are considered to be < 120 days. This conclusion is in full compliance with the EFSA Conclusion on the peer review of the pesticide risk assessment of the active substance Fenamiphos (European Food Safety Authority, 2019; EFSA Journal 2019;17(1):5557, 49 pp.).

 

Considerations on B/vB properties

The log Pow of the test item was determined to be 4.01 (please see IUCLID section 4.7) which is below screening threshold value for bioaccumulation potential of log Kow > 4.5. Furthermore, a dynamic 42-day study according to EPA 72-6 and EPA 40 CFR, Sec. 158.145 was conducted under GLP conditions to evaluate the bioconcentration of the 14C-radiolabelled test item by bluegill sunfish (Lepomis macrochirus). It was demonstrated that the substance is accumulated and excreted very rapidly by bluegill sunfish (Lepomis macrochirus) with a steady state mean bioconcentration factor (BCF) of 110 for whole fish (please refer to IUCLID section 5.3.1). This value is clearly below the criterium for bioaccumulative properties (B) of BCF <= 2000 given in REACH Annex XIII. It is hence concluded that the substance is neither vB nor B.

 

Consideration on T properties

The most critical toxicity effect value for aquatic species was determined for Daphnia magna. In a semi-static short-term test the lowest EC50 of the test item was determined as 1.06 µg a.i./L. This acute value is clearly below the screening criterion for T properties of 0.01 mg/L. The substance is therefore regarded as toxic (T) in accordance with the criteria given in REACH Annex XIII.

 

Conclusion on PBT/vPvB properties

The substance fulfils the criterion for T properties, but not for B/vB or P/vP. The substance is thus considered to be not PBT and not vPvB in accordance with the criteria laid down in Annex XIII of Regulation (EC) 1907/2006 (REACH).