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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.46 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 to Vinasses, residue of fermentation, depotassified.

 

No toxic effects were observed in acute and chronic tests performed at a nominal concentration of 100 mg/L. 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 considered as readily biodegradable, a chronic exposure in the aquatic environment is of low relevance. 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 of low relevance. Furthermore, due to the lack of any toxicological or ecotoxicological effects, it can be assumed that there is no risk 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.