Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
In general, enzymes are of very low toxicity due to ready biodegradability and very low bioavailability. In traditional acute toxicity testing, mortality has been the endpoint. However, because enzymes show very low toxicity, extremely high doses that are far above human exposure levels typically have been applied. Therefore, acute toxicity studies are not considered to provide appropriate knowledge and are as such not a relevant test system for enzymes (1).

Additionally, enzyme preparations have a very long history of being used as processing aids in the production of foods, such as in the dairy, wine, brewing and distilling, starch, and baking industries. Also, enzymes are used in various other industries e.g. detergent, textile, paper, leather, fuel ethanol, and animal feed (2). The production organism used in the manufacture of monoamine oxidase has a long history of safe use.

Industrial enzymes have a remarkably good safety profile with a long history of safe manufacture and use, with only a few enzymes causing respiratory sensitization (3). Acute inhalation toxicity studies are designed to test for lethality, which is not relevant for enzymes and the real endpoint of concern, allergenicity, cannot be evaluated in these types of studies.

More than 30 studies on acute inhalation toxicity in rodents revealed that for the majority of enzymes, no harmful effect could be detected at concentrations up to the highest possible concentrations administer and equivalent to nuisance dust levels (3). Acute inhalation toxicity studies with lethality as the endpoint makes this animal test system inappropriate in relation to relevant exposure to enzymes by inhalation and therefore lacking any capacity to provide new and/or useful knowledge.

Based on the weight of evidence presented, further live animal testing to investigate the acute inhalation toxicity of monoamine oxidase (aka CDX-616) is scientifically unnecessary as there is sufficient information for deriving an adequate qualitative hazard assessment.

(1) Enzymes REACH Consortium (2010). Data waiving argumentation for technical enzymes.
(3) HERA 2007. HERA Human and environmental risk assessment on ingredients of household cleaning products – Subtilisins (Proteases). Edition 2.0

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion