Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
65.3 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
653 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
6.53 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Sediment (marine water)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
4.7 µg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Additional information

PNEC aqua, STP and soil were derived from the available studies. For freshwater, a complete set of short-term endpoints was generated, therefore the relevant assessment factor was applied to the lowest EC50 (EyC50 for green algae). The same holds for STP PNEC. For the soil compartment, various data were generated on different taxa in view of the main use of the substance, i.e. as fertilizer, which is for its nature applied directly to the soil or, in other cases, to the crop. The set of data was comprised of:

- plants end-points (vegetative vigour and seedling emergence)

- soil microflora (nitrification and carbon transformation)

- Non-target arthropods (Aphidius rhopalosiphi and Typholdromus pyri)

Even if not all the data requirements for the application factor extrapolation method were developed (soil-dwelling invertebrates are missing), this approach was anyway followed (by using an assessment factor of 1000) because the lowest EC50 used is considered to be sufficiently protective. In fact, all the tests were performed at the maximum field rates or at multiple values of these rates and for none of the tests any effect was observed. Therefore, the EC50 used for the PNEC calculation is indeed a NOEC and there evidence from the other results obtained (seedling emergence, soil microflora) that this figure could have been higher. Also, test on non-target arthopods (NTA) were conducted at rates 1.5 fold higher than the maximum application rates and the results show that Agifert solid K+ does not produce letal effects nor negative effects on reproduction. Even if tested NTA are not the standard species recommended for the PNECsoil calculation, they represents however terrestrial organisms that can be exposed to the substance especially when used as fertilizer. The tested NTA species are considered the most sensitive for testing plant protection products and the obtained results on the same also give an indication on the long-term effects of Algifert solid K+. In fact, according to the results on NTA, no significant effect on reproduction is expected at rates higher than the field applcation rates.

Conclusion on classification

No environmental classification needed as all the aquatic EC50 available (96h LC50 for fish, 48h IC50 for Daphnia, 72h ErC50 for green algae) are above > 100 mg/L.