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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
5.2 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
52 µg/L

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
65 000 µg/L
Assessment factor:
1
Extrapolation method:
assessment factor

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:
PNEC soil
PNEC value:
0.62 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The aquatic toxicity of beta-mannosidase was based on a read-across from alpha-amylase as the two enzymes are similiar. In addition, since alpha-amylase has a high toxicity towards aquatic organisms, it has been chosen as a worst-case scenario.


The aquatic toxicity data for alpha-amylase were obtained from short term toxicity studies in species representing two trophic levels (i.e. algae and crustaceans). The most sensitive aquatic organism was the green alga Desmodesmus subspicatus and thus the ECr50 value of 5200 µg active enzyme protein (aep)/L detected in the algal growth inhibition assay was used for PNEC derivation and the assessment factors 1000 and 10000 were applied for fresh and marine water, respectively.

Conclusion on classification