Oxidase, monoamine

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
The results of aquatic toxicity tests that have been conducted on enzyme preparations by others demonstrate that they are not appreciably toxic to aquatic organisms including fish. For example, HERA [1] conducted a risk assessment on three very different classes of enzymes (enzyme preparations of alpha amylase, cellulase and lipase) commonly found in household products. EC50 values for fish ranged from greater than 300 to greater than 1,000 mg/L.

In 2002, an extensive review on enzymes was published entitled Collection of Information on Enzymes [2]. The review was supported by the Directorate General Environment of the European Commission and conducted by the Austrian Federal Environment Agency. Based on the studies reviewed, the report concluded that “enzymes seem unlikely to be dangerous to the aquatic environment due to their ready biodegradability and the low effects on aquatic life”. Although the database and number of enzymes reviewed were limited, the pattern of toxicity was clear and the authors were able to reach the above conclusion based on the studies reviewed. Investigations into ecotoxicity are mainly performed to establish knowledge on short-term aquatic toxicity and on the rate of biodegradability of the enzyme. Non-proteolytic enzymes, such as monoamine oxidase, should not be classified as harmful or toxic to the environment [3].

[1] HERA Human and environmental risk assessment on ingredients of household cleaning products - alpha-amylases, cellulases and lipases. 2005.
[2] Aberer W, Hahn M, Klade M, Seebacher U, Spök A, Wallner K, Witzani H (2002): Collection of information on enzymes. Final report. European Communities, ISBN 92-894-4218-2
[3] Enzymes REACH Consortium (2010). Data waiving argumentation for technical enzymes.

Description of key information

The results of aquatic toxicity tests that have been conducted on enzyme preparations by others demonstrate that they are not appreciably toxic to aquatic organisms including fish.  For example, HERA [1] conducted a risk assessment on three very different classes of enzymes (enzyme preparations of alpha amylase, cellulase and lipase) commonly found in household products.  EC50 values for fish ranged from greater than 300 to greater than 1,000 mg/L.

 

In 2002, an extensive review on enzymes was published entitled Collection of Information on Enzymes [2].  The review was supported by the Directorate General Environment of the European Commission and conducted by the Austrian Federal Environment Agency.  Based on the studies reviewed, the report concluded that “enzymes seem unlikely to be dangerous to the aquatic environment due to their ready biodegradability and the low effects on aquatic life”. Although the database and number of enzymes reviewed were limited, the pattern of toxicity was clear and the authors were able to reach the above conclusion based on the studies reviewed. Investigations into ecotoxicity are mainly performed to establish knowledge on short-term aquatic toxicity and on the rate of biodegradability of the enzyme. Non-proteolytic enzymes, such as monoamine oxidase, should not be classified as harmful or toxic to the environment [3].

 

The most sensitive EC50 fish toxicity value of greater than 300 mg aep/L for cellulase was used for the PNEC derivations.

 

[1] HERA Human and environmental risk assessment on ingredients of household cleaning products - alpha-amylases, cellulases and lipases. 2005.

[2] Aberer W, Hahn M, Klade M, Seebacher U, Spök A, Wallner K, Witzani H (2002): Collection of information on enzymes. Final report. European Communities, ISBN 92-894-4218-2

[3] Enzymes REACH Consortium (2010). Data waiving argumentation for technical enzymes.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

EC50

Remarks:

mg active enzyme protein/L

Effect concentration:

> 300 mg/L