Registration Dossier

Diss Factsheets

Physical & Chemical properties

Explosiveness

Currently viewing:

Administrative data

Endpoint:
explosiveness, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11/03/2021-23/03/2021
Reliability:
1 (reliable without restriction)
Justification for type of information:
Key study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.14 (Explosive properties)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Unknown 6
IUPAC Name:
Unknown 6
Constituent 2
Reference substance name:
Unknown 7
IUPAC Name:
Unknown 7
Constituent 3
Reference substance name:
Unknown 5
IUPAC Name:
Unknown 5
Constituent 4
Reference substance name:
Unknown 4
IUPAC Name:
Unknown 4
Constituent 5
Reference substance name:
Unknown 3
IUPAC Name:
Unknown 3
Constituent 6
Reference substance name:
Unknown 2
IUPAC Name:
Unknown 2
Constituent 7
Reference substance name:
Unknown 1
IUPAC Name:
Unknown 1
Test material form:
solid
Specific details on test material used for the study:
The material is composed of spray-dried cells of Escherichia coli BL21(DE3) expressing the dehalogenase enzyme. The Escherichia coli is grown in a fermenter on a nutrient medium mainly comprised of inorganic salts (including (NH4)SO2, K2HPO4, MgSO4 and FeSO4), yeast extract and glucose. In addition, SiO2 is added prior to spray drying. However, the final composition of the material is unknown due to the substance is to be registered as an UVCB (Unknown or Variable composition, Complex reaction products or Biological materials) and a definitive degree of purity cannot be determined.
Batch No.: 19111201045
Activity: 117 u/g Dehalogenase
Appearance: Beige/light brown solid
Storage conditions: Below -10 °C, dry

Results and discussion

Small-scale preliminary testsopen allclose all
Key result
Parameter:
other: Thermal stability
Remarks on result:
other: The test item showed multiple exothermal signals. Maximum energy release of 350 J/g and 251 J/g were recorded in two DSC-measurements.
Key result
Parameter:
sensitiveness to impact: impact energy (J)
Value:
40
Remarks on result:
negative (not further specified)
Key result
Parameter:
sensitiveness to friction: friction load (N)
Value:
360
Remarks on result:
negative (not further specified)
Key result
Parameter:
thermal sensitivity - Koenen test: diameter of the orifice plate
Value:
2
Remarks on result:
negative (not further specified)

Applicant's summary and conclusion

Interpretation of results:
other:
Conclusions:
The test showed only negative results.
The test item has no explosive properties in the sense of the European Commission Regulation (EC) No. 440/2008, method A.14.
Executive summary:

The test item contained inorganic substances and its composition was not completely known. Therefore, the main test on explosive properties according to European Commission Regulation (EC) No. 440/2008, method A.14. was performed. The test showed only negative results.


The test item had no explosive properties in the sense of the European Commission Regulation (EC) No. 440/2008, method A.14.