Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.01 µg/L
Assessment factor:
10
PNEC freshwater (intermittent releases):
5.53 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.101 µg/L
Assessment factor:
100
PNEC marine water (intermittent releases):
0.553 µg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
3.83 mg/L
Assessment factor:
100

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
2.226 µg/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:
3.848 µg/kg soil dw

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

The following available data on the test item has been used to conclude on the classification for aquatic toxicity:


 


Fish


Short-term


Japanese guideline study (GLP), Oryzias latipes (Himedaka), 96 h, semi-static, LC50 (96h) = 5.7 mg/L (time-weighted mean)


EU Method C.1 (GLP), Danio rerio (Zebra fish), 96 h, semi-static, LC50 (96h) = 6.5 mg/L (geometric mean)


Long-term


OECD 210 (GLP), Danio rerio, 36 d, flow-through, NOEC = 0.0101 mg/L


 


Aquatic invertebrates


Short-term


Japanese guideline study (GLP), Daphnia magna, 48 h, static: EC50 (48h) = 15 mg/L (geometric mean)


Long-term


OECD 211 (GLP), Daphnia magna, 21 d, semi-static, NOEC >= 2.281 mg/L


 


Aquatic algae


Japanese guideline study (GLP), Pseudokirchneriella subcapitata, growth rate, ErC50 (72h) = 0.553 mg/L (initial mean), NOErC (72h) = 0.202 mg/L


 


Microorganisms


ISO8192 (OECD 209), EC50(3h) = 383 mg/L nominal 


 


Biodegradation


EU Method C.4-D, readily biodegradable


 


Based on the results of the available studies the most sensitive endpoint for chronic toxicity was determined to be the 36 d NOEC for the effect parameter hatchability with a value of 0.0101 mg test item/L (long-term study with the freshwater fish Danio rerio according to OECD 210 (Nierzedska, 2022)). The NOEC for the effect parameter post-hatch survival was determined to be 0.0358 mg/L and the NOEC for the effect parameters fresh-weight, dry-weight and length were determined to be higher than or equal to 0.623 mg/L, respectively. The most sensitive endpoint for acute aquatic toxicity was established as the ErC50 (72h) = 0.553 mg/L of the algae toxicity study.


 


With these findings the registered substance is classified as acutely hazardous to the aquatic environment Category 1; H400 "Very toxic to aquatic life" and chronic hazardous to the aquatic environment Category 2; H411 "Toxic to aquatic life with long lasting effects" according to Regulation (EC) No 1272/2008.