Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.