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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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