Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.11 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.05 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.11 mg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
9.97 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
22.09 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
2.21 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
2.57 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

- Short-term toxicity to fish: Key study. Study on the analogue substance naringin, according to OECD TG 302 / EU Method C.1 (GLP study). The 96h-EC50 of the test item in zebrafish was determined to be higher than 100 mg/L and the NOEC was 100 mg/L, both based on mortality. Based on the available information for the read-across approach, the target substance has a 96h-EC50 > 105.1 mg/L and a NOEC ≥ 105.1 mg/L.

- Short-term toxicity to aquatic invertebrates: Key study. Study on the analogue substance naringin, according to OECD TG 202 / EU Method C.2 (GLP study). The 48h-EC50 in Daphnids was determined to be higher than 100 mg/L and the 48hNOEC was determined to be 100 mg/L, both based on mobility. Based on the available information for the read-across approach, the target substance has a 48h-EC50 > 105.1 mg/L and a NOEC ≥ 105.1 mg/L in daphnia.

- Toxicity to aquatic algae and cyanobacteria: Key study. Study on the analogue substance naringin, according to OECD TG 201 / EU Method C.3 (GLP study). The 72h-EC50 of the test item in freshwater algae was determined to be > 100 mg/L, the overall NOEC was determined to be 100 mg/L and the overall LOEC > 100 mg/L, all based on growth rate. Based on the available information for the read-across approach, the target substance has a 72h-EC50 > 105.1 mg/L and a NOEC ≥ 105.1 mg/L in algae.

- Toxicity to microorganisms: Weight of evidence: Based on the read-across approach from two analogue substances, the target substance is not inhibitory to microorganisms at 99.7 mg/L.

Conclusion on classification

Based on available data (EC50 from the three trophic levels ≥ 105.1 mg/L, based on the read-across approach) and since the substance is readily biodegradable, with a Log Kow < 4, the test item is not classified for aquatic toxicity, according to CLP regulation (EC) No. 1272/2008.