Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.44 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.22 mg/L

Marine water

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

STP

Hazard assessment conclusion:
no emission to STP expected

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
33 mg/kg food
Assessment factor:
300

Additional information

PNECs are calculated for aquatic compartments, based on the available data on algae, daphnia and fish. Yet, these compartments are not relevant when we take into consideration the use of the substance, only as a fertiliser. The track records of this use (authorised in Italy on the base of a plant toxicity/efficiency study) are good for many years.

Conclusion on classification

The substance has shown harmful effects in a 48 hours test on Daphnia. As it is not readily biodegradable, we could consider, according to dir. 67/548, that a classification R52/53 would be relevant. But the chronic daphnia toxicity test results have shown that the NOEC for chronic toxic effects is 32 mg/L, above the cut-off limit of 1.0 mg/L, therefore, this combined risk phrase does not apply, nor R52 alone as aquatic ecosystems are not at stake.

The same set of information, plus the fact that no substance in the mixture has a logKow equal or higher than 4.0, leads to no classification for aquatic environment in the context of CLP classification system.