Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Subtilisin has been tested in aquatic species representing three trophic levels i.e. algae, crustacaens and fish. Both long- and shortterm toxicity studies were performed. All studies were conducted according to OECD guidelines and in compliance with GLP.

Daphnia magnawas found to be the most sensitive species for acute effects and fish for chronic effects.

The results from the aquatic studies are following:

Daphnia magnaimmobilisation test:

EC50 (48 hours): geom. mean for all studies: 586 µg active enzyme protein (aep)/L

(1)

EC50 (48 hours): 0.306 mg TOS/L (measured) or 170 µg aep/L

NOEC (48 hours): 0.066 mg TOS/L (measured)

(2)

EC50 (48 hours): 0.92 mg/L (nominal) or 90 µg aep/L

NOEC (48 hours): 0.56 mg/L (nominal)

(3)

EC50 (48 hours): 2.5 mg /L (nominal) or 620 µg aep/L

NOEC (48 hours): 1.8 mg/L (nominal)

(4)

EC50 (48 hours): 64 mg/L (nominal) or 12.4 mg aep/L

NOEC (48 hours): 32 mg/L (nominal)

Daphnia magnareproduction assay:

EC10 (21d): 0.145 mg aep/L (measured)

NOEC (21d): 0.324 mg aep/L (measured)

Long-term toxicity to fish:

EC10 : 0.017 mg aep/L (measured)

NOEC: 0.042 mg aep/L (measured)

Acute toxicity to fish:

LC50 (96 hours): 14.6 mg TOS/L (measured) or 8.2 mg aep/L

NOEC: 10 mg TOS/L (nominal)

Toxicity to aquatic algae:

ErC50 (72 hours): 1.48 mg TOS/L (measured) or 830 µg aep/L

NOEC (72 hours): 0.0728 mg TOS/L (measured) or 41 µg aep/L

Additional information