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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.038 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
2.58 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:
5.14 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

Conclusion on classification

Short-term toxicity tests for fish, Daphnia and algae are available for the substance. In addition, two reliable EC10/NOEC values are available for long-term toxicity. The EC50 and LC50 value are between 1 and 10 mg/l, whereas the lowest EC10 is 1.9 mg/L for algae. As two reliable long-term toxicity endpoints are available chronic classification needs to be derived on both acute and chronic data and worst case should be taken. The substance is readily biodegradable, has a log Kow of 4.29 and acute data are between 1 -10 mg/L which would lead to classification as chronic 2 (H411). Based on chronic data Nebulone does not need to be classified. As the worst case needs to be taken Nebulone needs to be classified R51/53 according to Directive 67/548/EEC (DSD). The corresponding classification according to Regulation 1272/2008/EC (CLP) is H411 (Aquatic Chronic 2).