Teflubenzuron

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.006 µg/L

Assessment factor:

10

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0 µg/L

Assessment factor:

100

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

100 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

0.001 mg/kg sediment dw

Assessment factor:

100

Extrapolation method:

assessment factor

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0 mg/kg sediment dw

Assessment factor:

1 000

Extrapolation method:

assessment factor

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

0.004 mg/kg soil dw

Assessment factor:

50

Extrapolation method:

assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

0.67 mg/kg bw

Assessment factor:

3 000

Additional information

The PNEC derivation acc. to EPM was justified as follows:

 

PNEC freshwater sediment: 0.0162 µg/kg dw

K_(susp-water) = 652.45

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

 

PNEC_freshwater sediment= (K_(susp-water)/ RHO_(susp)) * PNEC_freshwater * 1000

 

PNEC marine water sediment: 0.00112 µg/kg dw

K_(susp-water) = 652.45

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

 

PNEC_marine sediment = (K_(susp-water)/ RHO_(susp)) * PNEC_marinewater * 1000

Conclusion on classification

a.s. = active substance = Teflubenzuron

Conclusion on classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

Classification related information

Biodegradability: not readily biodegradable (1% biodegradation after 28 days, OECD 301B)

Biodegradation half-life in freshwater:  29.6 days at 12 °C (entire system)

Half-life for hydrolysis: DT50 = 8.7 days at a temperature of 25 °C and a pH of 9

Log Pow: 4.98 at 20 °C

 

Aquatic acute toxicity

- Aquatic invertebrates: EC50 (48 h) = 0.0028 mg a.s./L (mean measured, Daphnia magna, OECD 202)

- Algae: ErC50 (96 h) ≥ 0.02 mg a.s./L (nominal, Desmodesmus subspicatus, EU Method C.3)

- Fish: LC50 (96 h) > 0.0065 mg a.s./L. (arithm. mean measured, L. macrochirus, OECD 203)

 

Aquatic chronic toxicity

- Algae: NOEC (96 h) >= 0.02 mg a.s./L (nominal, Desmodesmus subspicatus, EU Method C.3)

- Aquatic invertebrates: key values for freshwater and marine species are available

Freshwater: NOEC (21 d) = 0.062 µg a.s./L (nominal concentration, Daphnia magna, OECD 211)

Marine water: NOEC (27 d) = 0.043 µg a.s./L (mean measured, Mysidopsis bahia, EPA 540/9-82-024 ASTM Standard E1191-90)

- Fish: NOEC (28 d) > 0.0186 mg a.s./L (arithm. mean measured, Oncorhynchus mykiss, OECD 215)

 

Conclusion

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Teflubenzuron is not rapidly degraded. The substance was found to be not readily biodegradable. Further, the DT50 for biodegradation in the freshwater phase was determined to be 29.6 days at 12 °C. The DT50 for hydrolysis was measured to be 8.7 days at a temperature of 25 °C and a pH of 9. Following worst case assumption the substance is considered to be not rapidly degraded from aquatic compartments in accordance with the criteria given in section 4.1.2.9.5 in Annex I to Regulation (EC) No 1272/2008 (CLP). The most sensitive short-term test for the aquatic compartment was to aquatic invertebrates with Daphnia magna. The test revealed an EC50 (48 h) of 0.0028 mg a.s./L (mean measured). For the same species the lowest freshwater long-term result was determined: NOEC (21 d) = 0.062 µg a.s./L (nominal concentration, Daphnia magna, OECD 211). For marine species, Mysidopsis bahia was most sensitive with a NOEC (27 d) of 0.043 µg a.s./L (mean measured concentrations). The log Pow was determined to be 4.98. Based on these results, Teflubenzuron is classified for aquatic short-term (acute) toxicity, Category 1 (H400, Very toxic to aquatic life; M = 100) and for aquatic long-term (chronic) toxicity Category 1 (H410, very toxic to aquatic life with long-lasting effects; M = 1000) according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) 2020/1182.