CDX-403

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of 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 daphnids. For example, HERA (HERA, 2005. Human and Environmental Risk Assessment on ingredients of household cleaning products) 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 daphnids ranged from 450 to greater than 1,000 mg/L.

In 2002, an extensive review on enzymes was published entitled Collection of Information on Enzymes. 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(Collection of information on enzymes, European Commission, 2002).

The use of aquatic toxicity studies with daphnids in general are problematic for testing with large complex macromolecules like enzymes. This is particularly true for the testing of enzyme preparations which are mixtures and not pure substances. Daphnids are very sensitive to osmotic stress and other physical factors in their environment quite unrelated to any toxicological properties of the substance in question. The acute toxicity with daphnids is not a good test model for enzyme preparations.