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Diss Factsheets
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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
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 daphnids. 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 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 [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. 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. Non-proteolytic enzymes, such as ω-Transaminase, should not be classified as harmful or toxic to the environment [3].
There are several mitigating factors which indicate that both aquatic toxicity due to the presence of enzymes is unlikely to occur and that any observed toxicity could be the result of physical effects due to the complex composition of enzyme preparations which are classified at UVCB substances (Unknown or Variable Composition).
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. Previous use of daphnids for testing complex mixtures such as leachates have resulted in the need to modify the testing protocol to buffer for pH and other physical factors in the test material media. Round robin studies had to be performed to adapt the test protocol and still the results have been the subject of interpretation and misinterpretation. The acute toxicity with daphnids is not a good test model for enzyme preparations.
[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
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.