Registration Dossier
Registration Dossier
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EC number: 828-365-9 | CAS number: 113573-69-6
Flammability
Administrative data
Link to relevant study record(s)
Description of key information
Cellulase was freeze-dried and tested for flammability. The test showed that cellulase is not flammable.
Most of the enzymes are produced by fermentation, typically in solution. After the fermentation, enzymes are recovered as enzyme concentrate in a liquid form and further formulated as liquid products or granules.
The substance in contact with water is not considered to be highly flammable according to Regulation (EC) No 440/2008.
Based on this data, other enzymes are also expected to be Non-flammable (Not Classified).
Key value for chemical safety assessment
- Flammability:
- not classified
Additional information
Enzymes are globular proteins produced by fermentation i.e. typically in solution. After the fermentation, enzymes are recovered as enzyme concentrate in a liquid form and further formulated as liquid products or granules. The production process is described in Section 1.2 of IUCLID in more details. Decades of experience in production, handling and use of enzymes show that the substance does not react with water (e.g. the substance is manufactured with water or/and washed with water). The substance is soluble (see Section 4.8 of IUCLID) and stable in water. Therefore, the substance in contact with water is not considered to be highly flammable according to Regulation (EC) No 440/2008. Under REACH, enzymes are defined as enzyme concentrate, dry matter (1). As dry matter, proteins in general are not considered to be highly flammable according to Regulation (EC) No 440/2008. This is supported by the chemical structure of the proteins. Proteins contain reactive groups such as hydroxyl, carboxylic acid, amines, thiols groups etc. During combustion, carboxylic acid groups may go through decarboxylation and hydroxyl groups may be released as water vapor (3). The carboxylic acid may also promote char formation (2, 3). Proteins also contain nitrogen and sulfur which form a disulfide bond helping in contributing to its non-inherent flammability (2, 3). These properties have in fact led to the use of proteins as flame retardants (2, 3). Additionally, several proteins have already been tested using recognized method under REACH and CLP (e.g. UN Test N.1) and found not to be highly flammable according to Regulation (EC) No 440/2008, e.g. Protein hydrolyzates, rice bran (EC number: 305-224-5), Protein hydrolyzates, animal (EC number: 309-203-1), Insulin DesB30 (EC number: 944-550-8).
References: 1. Guidance for identification and naming of substances under REACH and CLP, Version 2.1.
2. https://onlinelibrary.wiley.com/doi/full/10.1002/fam.2386
3. https://patents.google.com/patent/WO2000029662A1/en Based on above weight of evidence, a study for flammability is deemed unnecessary.
Justification for classification or non-classification
Not classified
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.
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