Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.28 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.3 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.128 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
23.753 µg/kg sediment dw

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
46.61 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The aquatic ecotoxicological Chemical Safety Assessment bases on a long-term dataset on the two trophic levels (fish and algae), whereof the fish is the most sensitive (EC10 of 0.064 mg/L). The Equilibrium Partitioning Method (EPM) was applied to derive PNECs for sediment and soil. Considering the low mammalian toxicity in a chronic study no further experiment seems justified and the EPM-based PNECs can be used in the risk assessment.

Conclusion on classification

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


 


Classification related information


Biodegradation: readily biodegradable (86% degradation, 10-day window fulfilled, OECD TG 301-D)


Partition coefficient octanol-water: log Pow = 4.276 at 20 °C (OECD 107, shake flask method)


Bioconcentration: BCF = 861 L/kg (QSAR estimate)


 


Key information on aquatic short-term (acute) toxicity


Fish: LC50 (96 h) = 0.13 mg/L (mean measured, Pimephales promelas, OECD 203)


Invertebrates: EC50 (48 h) = 3.8 mg/L (nominal, Daphnia magna, OECD 202)


Algae: EC50 (72 h, growth rate) = 3 mg/L (initially measured, Pseudokirchneriella subcapitata, OECD 201)


 


Key information on long-term (chronic) aquatic toxicity


Fish: EC10 (28 d) = 0.064 mg/L (geom. mean measured, Pimephales promelas, OECD 210)


Algae: EC10 (72 h, growth rate) = 1.6 mg/L (initially measured, Pseudokirchneriella subcapitata, OECD 201)


 


Conclusion


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. However, the log Pow was determined to be > 4 and the BCF was estimated to be 861 L/kg. The most sensitive short-term test for the aquatic compartment was the toxicity test to fish (Pimephales promelas). The test revealed a LC50 (96 h) of 0.13 mg/L (mean measured). The lowest long-term result was obtained for the same species: EC10 (28 d) = 0.064 mg/L (geom. mean measured). In a growth inhibtion test with P. subcapitata a 72-hour EC10 (growth rate) of 1.6 mg/L (initially measured) was determined. Long-term results for aquatic invertebrates are not available. Based on the acute LC50 for fish the substance is classified as aquatic short-term (acute) toxicity Cat. 1 (H400, M = 1); based on the chronic EC10 for fish and the acute EC50 for aq. invertebrates the substance is classified aquatic long-term (chronic) toxicity Cat. 2 (H411) according to Regulation (EC) No 1272/2008 (CLP), as amended for the seventeenth time in Regulation (EU) 2021/849.