Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.148 mg/L
Assessment factor:
1 000
PNEC freshwater (intermittent releases):
1.48 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.015 mg/L
Assessment factor:
10 000

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
250 mg/kg soil dw
Assessment factor:
10

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Aquatic environment classification

Biofert Plusz proved to be readily biodegradable.

The lowest acute EC/LC50 value in aquatic tests is the EC50 of 148 mg dry matter/L based on geometric mean measured concentrations for the green algal species Desmodesmus subspicatus.

Due to its ready biodegradability and low log Pow (main component L-Threonine) the substance is not to be classified as dangerous/hazardous for the environment according to Directive 67/548/EEC and according to the Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP Regulation):

Lowest reliable L(EC)50 value:                 148 mg dry matter/L (algae)

Ready biodegradable                                yes

log Pow                                                     < 3 (main component)

Special concern:                                       no

 

According to 67/548/EEC Annex 1:      not classified

 

According to GHS:

Hazardous to the environment      not classified, no hazard statement

                                                      Reason for classification:    L(E)C50: > 100 mg/L; readily biodegradable, log Pow<4 (main component)

Hazardous to the atmospheric environment:

(Hazardous to the ozone layer: This includes substances which are listed in Annex I to Regulation (EC) No 2037/2000 of the European Parliament and of the Council of substances that deplete the ozone layer (1) and its subsequent amendments):
Biofert Plusz is not listed in Annex I of (EC) No 2037/2000.

 

M-Factor:                                       No

Labelling:                                        No Signal word and Pictogram for environmental hazards