Registration Dossier
Registration Dossier
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EC number: 232-565-6 | CAS number: 9000-90-2
Categories
- Category name:
- Ecotoxicity of non proteolytic enzymes
Justifications and discussions
- Category definition:
- Non-proteolytic enzymes have a similar ectoxicity profile. An review of available dataindicates that alpha-amylase is worst case scenario within aquatic toxicity and aquatic toxicity data obtained with alpha-amylase hence cover data for non-proteolytic enzymes in general.
- Category description:
- Alpha-amylase showed the highest toxicty in this category and thus read-across to alpha-amylase is considered to ensure safety for enzymes within this category, where no data are available.
- Category rationale:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
[Please provide information for all of the points below. Should you wish to add supporting documents, please attach the document(s) in the field 'Reports', and indicate this in the appropriate point.]
1. CATEGORY HYPOTHESIS
Enzymes and other proteins are polymers built of different combinations of the 20 common amino acids. The sequence and length of the amino acids in the polymer differ between enzymes, and this determines the 3-dimensional structure, the activity and specificity of the enzyme. The physico-chemical characteristics of enzymes are mainly dependent on the amino acids building the enzyme. Since all enzymes are built up of a combination of the same 20 common amino acids, The eco-toxicity profile is assumed to be similar for non-proteolytic enzymes regarding the general low toxicity of enzymes. Non-proteolytic enzymes acitiity is specific to a certain substrate and in general of non to low toxicity towards aquatic organisms.
2. CATEGORY JUSTIFICATION
Aquatic toxicity data for a variety of non-proteolytic enzyme clasases are available among those for alpha-amylase, cellulase and cellulase and data show that non-proteolytic enzymes in general are non- or of low toxicity towards aquatic organisms. The worst case represented by alpha-amylases and thus data from amylases are judged to be representativ for non-proteolytic enzymes and read-across is fully applicable.
3. APPLICABILITY DOMAIN OF THE CATEGORY
Data are applicable to non-proteolytic enzymes.
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