Registration Dossier
Registration Dossier
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EC number: 232-808-6 | CAS number: 9026-00-0
Flammability
Administrative data
- Endpoint:
- flammable solids
- Remarks:
- The study is performed on dried test material, see justification.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1/2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Under REACH, enzymes are UVCB substances and their composition is described as "an enzyme concentrate, dry matter (excluding water by calculation)". The ECHA guidance on substance identification, section 4.3.2.3. states that "The enzyme protein together with the other constituents deriving from the fermentation or extraction process, but excluding any water, which may be separated without affecting the stability of the enzyme protein or changing its composition, should be regarded as the substance for identification purposes."
However, enzymes are manufactured and recovered in liquid form (water solutions) and further formulated as liquid products or sometimes also as dried granules. For this substance, only the aqueous solution form is applicable.
After consulting the ECHA Helpdesk on which form of the substance should the flammability be determined/waived, it was decided to test the dried sample created for the identification of this enzyme substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- UN Manual of Tests and Criteria: Test N.1 (Test method for readily combustible solids)
- Version / remarks:
- Screening study UN MTC 33.2.1.4.3.1 , 6th revised edition, 2015
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Active enzyme protein of sterol esterase (EC no. 232-808-6, CAS no. 9026-00-0, EC name: Esterase, cholesterol, Enzyme Class no. 3.1.1.13)
- Molecular formula:
- Not applicable. See remarks.
- IUPAC Name:
- Active enzyme protein of sterol esterase (EC no. 232-808-6, CAS no. 9026-00-0, EC name: Esterase, cholesterol, Enzyme Class no. 3.1.1.13)
- Reference substance name:
- Proteins as constituents of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Proteins as constituents of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Carbohydrates as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Carbohydrates as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- liquid
- Details on test material:
- - substance type: UVCB
- Physical state: liquid; dried form for certain tests
- Lot/batch No.: batch P190023B
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
- Specific details on test material used for the study:
- Dried sample was used for the flammability test.
Results and discussion
Flammable solids
- Key result
- Test procedure:
- burning rate test with wetted zone
- Burning time:
- ca. 0 min
- Moisture (wt %):
- 4.9
- Remarks on result:
- other: Brief ignition, but no combustion propagation along 200 mm of the train within the 2-minute test period
Any other information on results incl. tables
The tests were performed at 22 degr. C / 975 hPa.
Median particle size 25 µm was determined by sieve analysis according to
DIN 66165 part 1 and 2.
Fractions with a particle size in sample: 94 % w/w < 53 µm, 71 % w/w <
32 µm, 33 % w/w < 20 µm.
Applicant's summary and conclusion
- Interpretation of results:
- not classified based on GHS criteria
- Conclusions:
- Not readily combustible solid of Division 4.1.
- Executive summary:
The burning rate of the dried test substance was tested according to Division 4.1, UN Test N.1 in an external laboratory.
Brief ignition, but no combustion propagation along 200 mm of the train within the 2 -minute test period was observed. In conclusion, even the dried form of the test substance is not "readily combustible solid" of UN Division 4.1.
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