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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
toxicity to non-target arthropods on inert substrate (NTA other than pollinators)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely
Justification for type of information:
This study does not need to be conducted. The enzyme has a very low Henry’s Law constant (<10-4) and a low octanol-water partition coefficient (<0). Therefore, exposure to agricultural soil via sludge application as well as via aerial deposition is very low. Exposure to soil may occur if waste water is discharged off via septic tank. According to the EUSES calculations, less than 0.01% of enzymes entering a STP will bind to sludge. As enzymes are degradable at both aerobic and anaerobic conditions, a high rate of inactivation and degradation of the enzyme in soil is expected. Assuming a degradation rate in soil at the same level as degradation rate in surface water, i.e. a half life of 5 hours, calculations show that the PEC for soil is approximately 25% below the PEC for the surface water. Thus enzymes applied to agricultural soils via sludge application do not present a risk to the soil compartment due to sludge application. Enzymes may potentially leach into the soil, if waste water is discharged to a septic tank. The chemical safety assessment based on the equilibrium partitioning method showed that the enzyme does not exhibit a risk to soil living organisms in this situation.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion