Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Valid aquatic toxicity tests for fish, aquatic invertebrates and algae are available for Vinasses, residue of fermentation and are read-across among the category members.

 

Acute values determined are >56 mg/L (EC50) and >58 mg/L (LC50) for Pseudokirchneriella subcapitata and Cyprinus carpio, respectively. NOECs determined in chronic studies are 23 and 42 mg/L for Daphnia magna and 56 mg/L for Pseudokirchneriella subcapitata. These results clearly indicate, that Vinasses, residue of fermentation are neither acute nor chronic toxic to aquatic organisms among all trophic levels. The lowest no observed effect concentration, obtained from results of a chronic test on Daphnia magna, was used for the derivation of PNECaquatic.

 

Furthermore, a respiration inhibition test on activated sludge, using the same test substance resulted in an EC50(3h) > 100 mg/L, underlining the absence of harmful effects on the aquatic environment.

 

Since the substance is readily biodegradable, a chronic exposure in the aquatic environment can be excluded. Together with the absence of any harmful or toxic effects on aquatic organisms, further testing on aquatic vertebrates is scientifically unjustified.

 

The same applies to the terrestrial environment. Due to the ready biodegradability, a chronic exposure of terrestrial organisms is excluded. The ready biodegradability implies good metabolization in microorganisms, and presumably vertebrates as well, which is underlined by the toxicokinetic assessment for the category members. Furthermore, due to the lack of any toxicological or ecotoxicological effects, it can be safely assumed that there is no risk from any of the category members for terrestrial organisms and no effects of secondary poisoning to predators, including birds. This assessment is underlined by the fact that Vinasses have been used as animal food for decades and also by their use as fertilizer. Therefore, no tests on terrestric organisms are provided and no PNECs derived.

Conclusion on classification

The available data on environmental toxicity of the substance are conclusive but not sufficient for classification according to the DSD (67/548/EEC) and CLP (1272/2008/EC) criteria.