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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Invertebrates: Under the conditions of the test, Sedolisin, batch PPF38268 was found not to be toxic to Daphnia magna at a nominal concentration up to 119.2 mg enzyme concentrate dry matter/L (equivalent to 24.7 mg active enzyme protein/L) after 48h exposure. Thus, no 48h EC50 could be calculated and must be > 119.2 mg enzyme concentrate dry matter/L (> 24.7 mg active enzyme protein/L).


Subtilisin, batch PPA 4046 was used as a read-across and the 48-hour EC50 of the test substance for the immobilisation of Daphnia magna was nominal 60.4 mg enzyme concentrate dry matter/L corresponding to 12.4 mg active enzyme protein/L.


Algae: Under the conditions of the test, Sedolisin, batch PPF38268 was found not to be toxic to Daphnia magna at a nominal concentration up to 119.2 mg enzyme concentrate dry matter/L (24.7 mg aep/L) after 48h exposure. Thus, no 48h EC50 could be calculated and must be > 119.2 mg enzyme concentrate dry matter/L (equivalent to > 24.7 mg active enzyme protein/L).


Subtilisin was used as read-across: The EC50 was 9.8 mg enzyme concentrate dry matter/L (corresponding to 5.02 mg active enzyme protein/L). NOEC for the growth rate was 0.042 mg enzyme concentrate dry matter/L. 

Additional information

The Subtilisin EC50 will be used as worst-case scenario.