Oxidase, monoamine

Toxicity to aquatic algae and cyanobacteria

Link to relevant study record(s)

Reference

Endpoint:

toxicity to aquatic algae and cyanobacteria

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
The widespread use of enzymes has been followed by investigations relevant for ecotoxicity. Investigations are mainly performed to establish knowledge on short-term aquatic toxicity and on the rate of biodegradability of the enzyme. Algae growth inhibition tends to be the most sensitive aquatic endpoint reported for enzyme preparations in the literature with EC50 concentrations ranging from 99 to >1,000 mg/L [2]. The published data support that enzyme preparations are not highly inhibitory to the growth of aquatic algae and non-proteolytic enzymes, such as monoamine oxidase, should not be classified as harmful or toxic to the environment [1].

Interpretation of test results is complicated due to the fact that enzyme preparations are mixtures. It should be noted that enzymes are produced through a fermentation process where micronutrients which are important to the growth of the bacteria and fungal species producing the enzymes are the same nutrients that are likely to impact the growth of algae. This raises complications in the interpretation of the results and calls into question the applicability of an algal growth inhibition study design for testing enzyme preparations which are likely to contain similar micronutrients that are in the growth media for the algal controls.

[1] Enzymes REACH Consortium (2010). Data waiving argumentation for technical enzymes.
[2] HERA Human and environmental risk assessment on ingredients of household cleaning products - alpha-amylases, cellulases and lipases. 2005.

Description of key information

The widespread use of enzymes has been followed by investigations relevant for ecotoxicity. Investigations are mainly performed to establish knowledge on short-term aquatic toxicity and on the rate of biodegradability of the enzyme. Algae growth inhibition tends to be the most sensitive aquatic endpoint reported for enzyme preparations  in the literature with EC50 concentrations ranging from 99 to >1,000 mg/L [2].  The published data support that enzyme preparations are not highly inhibitory to the growth of aquatic algae and non-proteolytic enzymes, such as monoamine oxidase, should not be classified as harmful or toxic to the environment [1].  

 

Interpretation of test results is complicated due to the fact that enzyme preparations are mixtures.   It should be noted that enzymes are produced through a fermentation process where micronutrients which are important to the growth of the bacteria and fungal species producing the enzymes are the same nutrients that are likely to impact the growth of algae.  This raises complications in the interpretation of the results and calls into question the applicability of an algal growth inhibition study design for testing enzyme preparations which are likely to contain similar micronutrients that are in the growth media for the algal controls.  

 

The most sensitive EC50 algae toxicity value of 99 mg aep/L for lipases was used for the PNEC derivations.

 

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

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

Key value for chemical safety assessment

EC50 for freshwater algae:

99 mg/L