Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
4.47 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.447 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:
191.316 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
19.132 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:
38.032 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

The PNEC derivation was as follows justified:


PNEC freshwater sediment:


K_(susp-water) = 10700


RHO_(susp) = 1150


Conversion factor (wwt -> dwt): 4.6


PNEC_freshwater sediment


= (K_(susp-water) / RHO_(susp)) * PNEC_water * 1000


= (10700/1150) * 0.00447 * 1000


= 41.59 mg/kg wwt


= 191.316 mg/kg dw


 


PNEC marine water sediment:


K_(susp-water) = 1.25


RHO_(susp) = 1150


Conversion factor (wwt -> dwt): 4.6


PNEC_marine water sediment


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


= (10700/1150) * 0.000447 * 1000


= 4.159 mg/kg wwt


= 19.1316 mg/kg dw


 


PNEC soil:


K_(soil-water) = 12800


RHO_(soil) = 1700


Conversion factor (wwt -> dwt): 1.13


PNEC_soil


= (K_(soil-water) / RHO_(soil)) * PNEC_freshwater * 1000


= (12800/1700) * 0.00447 * 1000


= 33.6565 mg/kg wwt


= 38.0318 mg/kg dw

Conclusion on classification

Acute aquatic toxicity:


96 h, LC50 (Danio rerio): >100 mg/L (nominal concentration)


48 h, EC50 (Daphnia magna): >100 mg/L (nominal concentration)


72 h, ErC50 (Pseudokirchneriella subcapitata): >100 mg/L (nominal concentration)


 


Aquatic chronic toxicity:


72 h, ErC10 (Pseudokirchneriella subcapitata): >100 mg/L (nominal concentration)


21 d, NOEC (Daphnia magna): 44.7 µg/L (time weighted average measured concentration)


35 d, NOEC (Danio rerio): to be determined


Biodegradation: readily biodegradable: 65 % after 28 days (% degradation O2 consumption, OECD 301 D)


Partition coefficient: log Kow = >6.5 at 20 °C (estimated: 13 at 25 °C)


 


Classification according to CLP


The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The test substance was found to be readily biodegradable under the test conditions. In all aquatic tests the test item showed no toxic effect on the tested species. The determined (L)EC50 and EC10 for fish, Daphnia magna and green algae were >100 mg/L (nominal). The 21 d NOEC to Daphnia magna was determined to be 44.7 µg/L (TWA measured concentration). Based on these results, the substance is not classified for short-term (acute) aquatic toxicity nor classified for long-term (chronic) aquatic toxicity according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) 2020/1182.