Registration Dossier
Registration Dossier
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EC number: 232-796-2 | CAS number: 9025-49-4
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 8.2 µg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 82 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.82 µg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
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:
- 1.1 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 aspergillopepsin I was assessed in daphnia, algae and fish. Data from similar enzymes i.e. subtilisin and sedolisin were used for the fish acute toxicity and algal growth inhibition, respectively.
The LC50 value derived from the fish acute toxicity test (8.2 mg aep/L) was used for PNEC derivation and the assessment factors 1000 and 10000 were applied for fresh and marine water, respectively.
The PNEC value for STP is based on actual measurements of enzyme concentration in STP connected to manufacturing site. Up to 65000 µg active enzyme protein were detected in STP connected to manufacturing site and since there was no negative impact observed, this concentration is the estimated PNEC value for STP.
PNEC values for sediment exposure have not been derived because the test enzyme is readily biodegradable, highly water soluble and has a very low potential for adsorption to sediments. Exposure of the sediment to toxicologically significant concentrations of the test substance is thus not expected.
As no soil ecotoxicity data are available for the test enzyme, the PNEC for soil is based on the PNEC for surface water using the equilibrium partitioning method. PNEC soil was estimated to 1.1 µg active enzyme protein/kg soil dw.
The test enzyme is not expected to cause any significant secondary poisoning as it is ready biodegradable and has no bioaccumulation potential. Furthermore, as the test enzyme is a protein it is expected to be degraded in the gastrointestinal tract. Thus, PNEC oral is not relevant.
Conclusion on classification
Not classified
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