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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.015 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.03 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.292 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Classification related key information

Not readily biodegradable: 1% (ThOD) in 28 days (OECD 301 D)

Inherently biodegradable: 84% (ThOD) in 28 days (OECD 302 C)

Log Kow = 2.72

Acute toxicity:

- to fish: LC50 (96h) = 6.7 mg/L for Danio rerio (OECD 203)

- to aquatic invertebrates: EC50 (48h) = 3.0 mg/L for Daphnia magna (OECD 202)

- to algae: ECr50 (72h) = 24 mg/L, for Desmodesmus subspicatus (OECD 201)

Chronic toxicity:

- to fish: NOEC (28d) = 0.15 mg/L for Oncorhynchus mykiss (OECD 204 and 215)

- to aquatic invertebrates: NOEC (21d) = 0.32 mg/L for Daphnia magna (OECD 211)

- to algae: NOEC (72h) = 3.2 mg/L for Desmodesmus subspicatus (OECD 201)

 

Classification justification according to CLP

Based on the data above, Preventol is considered not rapidly biodegradable. The acute aquatic toxicity EC/LC50 values are in the range from 1 to 10 mg/L for fish and invertebrates. Valid chronic toxicity data are available for fish, invertebrates and algae with the lowest NOEC for fish being 0.15 mg/L. Therefore, Preventol KMX needs to be classified and labelled as environmental hazard Chronic Cat. 2 according to the Regulation (EC) No. 1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2ndATP).

 

Classification justification according to DSD

Based on the data above, Preventol is considered to have a low potential for accumulation and is not rapidly degradable. The acute aquatic toxicity EC/LC50 values are in the range from 1 to 10 mg/L for fish and invertebrates. Therefore, Preventol KMX needs to be classified as environmental hazard R51/53 according to the Directive 67/548/EEC.