Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
1.55 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:
1.85 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 data were obtained from short term toxicity studies in species representing three trophic levels (i.e. algae, crustacean and fish).

Fish:

No mortality in either the control or the test groups was noted throughout the exposure period, therefore the EC50 could not be calculated. Under the conditions of the test, the 96 hour LC50 value for Lipase, batch PPW 21180 with rainbow trout was > 262.3 mg enzyme concentrate dry matter/L equivalent to 37.4 mg active enzyme protein (aep)/L.

The 'no-observed effect concentration' for Lipase, batch PPW 21180 with rainbow trout was 54.8 mg enzyme concentrate dry matter/L, equivalent to 7.8 mg aep/L.

The results are based on the nominal concentrations - which are the lower values - as a worse case.

 Invertebrates:
Under the conditions of the test, Lipase, batch PPW 21180 was not found to be acutely toxic to Daphnia magna up to 262.3 mg enyzme concentrate dry matter/L (equivalent to 37.4 mg active enzyme protein/L) and thus no 48-hr EC50 value could be determined and must be over the highest tested concentration. NOEC was 262.3 mg enyzme concentrate dry matter/L (equivalent to 37.4 mg active enzyme protein/L). The results are based on the nominal concentrations - which are the lower values - as a worse case.

 Algae:
Lipase, batch PPW 21180 did not inhibit the growth of Selenastrum capricornutum, at any concentration under the conditions of this test. The ErC50 (0 – 72 hours) was > 262.3 mg enzyme concentrate dry matter/L (equivalent to 37.4 mg active enzyme protein/L).

The EbC50 (72 hours) was > 262.3 mg enzyme concentrate dry matter/L. The No-observed-effect concentration NOEC was 262.3 mg enzyme concentrate dry matter/L (equivalent to 37.4 mg active enzyme protein/L). The results are based on the nominal concentrations - which are the lower values - as a worse case.

Lipase, batch PPW3983 is inhibitory to the growth ofDesmodesmus subspicatus. NOEC was 38.1 mg enzyme concentrate dry matter/L (equivalent to 6.2 mg active enzyme protein/L). The 72h ErC50 is 94.2 mg enzyme concentrate dry matter/L (equivalent to 15.5 mg active enzyme protein/L) and the EbC50 is 92.3 mg enzyme concentrate dry matter/L.

Inhibition control carried out with non-proteolytic enzymesin the test of ready biodegradability showed no inhibition of the activated sludge inoculum at an enzyme concentration above the expected levels in inlet to sewage treatment plants (STPs). Monitoring of enzymes in the inlet to municipal STPs (in Denmark) resulted in concentrations of less than 2 µg active enzyme protein (aep)/L which are below the initial concentration used in tests for ready biodegradability, where no inhibitory effects were observed. It is concluded that a study on activated sludge respiration inhibition does not need to be conducted. Therefore, the test enzyme is not considered to be toxic to microorganisms.

The ErC50 for algae was 15.5 mg active enzyme protein/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 aep/L 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 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 enzyme 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 1.85 µg active enzyme protein/kg soil ww.

The 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

Based on the aquatic toxicity studies and the ready biodegradation of the enzyme, lipase is not classified.