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Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
boiling point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 103 (Boiling Point)
GLP compliance:
no
Type of method:
differential scanning calorimetry
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch Number S5690
- Expiration date of the lot/batch: Not specified
- Purity test date: Not applicable


Key result
Decomposition:
yes
Decomp. temp.:
ca. 116 °C

The DSC plot for the substance is attached as Plot 1 below.

Conclusions:
Three mildly exothermic events were observed with onset temperatures of 116.7°C, 210.0°C and 237.7°C, the normalized energy outputs being 27.6, 8.4 and 7.7 J/g respectively. This profile is indicative of gradual sample decomposition.
Executive summary:

The boiling point and thermal staibity of Escherichia Coli dehalogenase powder was evaluated by Differential Scanning Calorimetry. Three mildly exothermic events were observed with onset temperatures of 116.7°C, 210.0°C and 237.7°C, the normalized energy outputs being 27.6, 8.4 and 7.7 J/g respectively. This profile is indicative of gradual sample decomposition. No thermal event that could be attributed to melting or boiling points was observed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
GLP compliance:
no
Type of method:
differential scanning calorimetry

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:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: S5690
- Expiration date of the lot/batch: Not specified
- Purity test date: Not specified

Results and discussion

Melting / freezing point
Key result
Decomposition:
yes
Remarks:
Three mildly exothermic events were observed with onset temperatures of 116.7°C, 210.8°C and 237.7°C, the normalized energy outputs being 27.6, 8.4 and 7.7 J/g respectively. This profile is indicative of gradual sample decomposition.
Remarks on result:
not determinable

Any other information on results incl. tables

Please refer to Plot 1 attached to end point 4.3 Boiling Point.

Applicant's summary and conclusion

Conclusions:
Three mildly exothermic events were observed with onset temperatures of 116.7°C, 210.0°C and 237.7°C, the normalized energy outputs being 27.6, 8.4 and 7.7 J/g respectively. This profile is indicative of gradual sample decomposition, no exothermic event that could be attributed to melting was observed.
Executive summary:

The melting point and thermal stability of Escherichia Coli dehalogenase powder was evaluated by Differential Scanning Calorimetry. Three mildly exothermic events were observed with onset temperatures of 116.7°C, 210.8°C and 237.7°C, the normalized energy outputs being 27.6, 8.4 and 7.7 J/g respectively. This profile is indicative of gradual sample decomposition. No thermal event that could be attributed to melting or boiling point was observed.