Registration Dossier
Registration Dossier
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EC number: 944-549-2 | CAS number: -
Melting point / freezing point
Administrative data
Link to relevant study record(s)
- Endpoint:
- melting point/freezing point
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Remarks on result:
- not determinable
- Remarks:
- no melting point could be determined. the observed broad endotherm in the range 192-205 °C, probably representing a thermal transition
- Conclusions:
The melting point of insulin aspart precurser was estimated based on read across to MI3 (S2) and X14DesB30 (S3). As can be seen from the molecular structure (see attached document in section 13) the target substance is a small protein consisting of 59 amino acids have at least 49 amino acids in common with the source substances (consisting of 50-53 amino acids) and having very identical amino acid sequences. Based on these structural similarities very similar physical chemical properties would be expected.
The determination of the melting point for S2 (MI3) and S3 (X14desB30) was performed using DSC in accordance to OECD guideline 102 (1995) and EC Directive 92/69/EEC Methods A1. The melting point was not determinede. The observed broad endotherm in the range 192-205 °C, probably representing a thermal transition rather than a melting point.
Therefore, the same conclusion for the target substance (Insulin Aspart Precursor).- Executive summary:
The melting point of insulin aspart precurser was estimated based on read across to MI3 (S2) and X14DesB30 (S3). As can be seen from the molecular structure (see attached document in section 13) the target substance is a small protein consisting of 59 amino acids have at least 49 amino acids in common with the source substances (consisting of 50-53 amino acids) and having very identical amino acid sequences. Based on these structural similarities very similar physical chemical properties would be expected.
The determination of the melting point for S2 (MI3) and S3 (X14desB30) was performed using DSC in accordance to OECD guideline 102 (1995) and EC Directive 92/69/EEC Methods A1. The melting point was not determinede. The observed broad endotherm in the range 192-205 °C, probably representing a thermal transition rather than a melting point.
Therefore, the same conclusion for the target substance (Insulin Aspart Precursor) applies, justified by the read-across hypothesis.
For further details, please refer to read across justification documennt in section 13
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003.06.30 - 2003.07.14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 102 (Melting point / Melting Range)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.1 (Melting / Freezing Temperature)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- differential scanning calorimetry
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL (MI3)
- Appearance: cream powder
- Source and lot/batch No.of test material: QC202426
- Expiration date of the lot/batch: June 2004
- Purity test date: 2003-06-18
- Purity: 84% w/w (stated ny Sponsor)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Frozen below - 10°C - Key result
- Remarks on result:
- not determinable
- Remarks:
- no melting point could be determined. the observed broad endotherm in the range 192-205 °C, probably representing a thermal transition
- Conclusions:
- Determination of the melting temperature was performed in accordance to OECD 102. It was not possible to determine the melting temperaure, since a small broad endotherm, considered to be a thermal transistion rather than melting, was observed between approximately 192 and 205°C.
- Executive summary:
Determination of the melting temperature was performed in accordance to OECD guideline 102 (1995) and EC Directive 92/69/EEC Methods A1 and A2. The thermal behavior of MI3 (dried) was assessed by Differential Scanning Calorimetry. It was not possible to determine the melting point. An endotherm onset nominally 193°C was generated, and because of its broad nature, was considered to be a thermal transition rather than a melting event.
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003.05.12 -2003.10.24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 102 (Melting point / Melting Range)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.1 (Melting / Freezing Temperature)
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- differential scanning calorimetry
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL (X14desB30, dried)
- Appearance: cream powder
- Source and lot/batch No.of test material: QX14203119
- Expiration date of the lot/batch: June 2004
- Purity test date: 2003-06-18
- Purity: 75% w/w
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Frozen below - 10°C - Key result
- Remarks on result:
- not determinable
- Remarks:
- The melting point could not be determined.
- Conclusions:
- The melting point of X14desB30 (dried) was assessed by Differential Scanning Calorimetry. The procedure conformed to the OECD Guideline 102 (1995). No melting point was determined.
- Executive summary:
The melting point of X14desB30 (dried) was assessed by Differential Scanning Calorimetry. The procedure conformed to the EC Directive 92/69/EEC Method A1 and OECD Guideline 102 (1995). An endotherm with an onset at nominally 185oC was generated, and because of its broad nature, was considered a thermal transition rather than a melting event.
No melting point was determined.
Referenceopen allclose all
The table below lists the thermal data . A small broad endothermic peak between nominally 192 and 205°C , considered to be a thermal transition rather than a melting point.
Parameter |
First Scan |
Second Scan |
Onset (°C) |
191.8 |
194.4 |
Peak (°C) |
199.3 |
200.8 |
Endset (°C) |
205.3 |
205.1 |
Enthalpy (J/g) |
-15.06 |
-7.15 |
The table below lists the thermal data. A small broad endothermic peak between nominally 186 and 198°C , considered to be a thermal transition rather than a melting point.
Parameter |
First Scan |
Second Scan |
Onset (°C) |
185.8 |
185.3 |
Peak (°C) |
193.1 |
192.8 |
Endset (°C) |
198.2 |
197.7 |
Enthalpy (J/g) |
-8.45 |
-8.40 |
Description of key information
Data on target substance not available. Thus, read-across has been applied using data from source substances (S2, S3).
As can be seen from the molecular structure (see attached document in section 13) the target substance is a small protein consisting of 59 amino acids have at least 49 amino acids in common with the source substances (consisting of 50-53 amino acids) and having very identical amino acid sequences. Based on these structural similarities very similar physical chemical properties would be expected. This is further documented by the results from physical chemical guideline testing for S2 and S3 where the test results found for melting point, boiling point, flammability, self-ignition, and explosion were identical.
Specifically, for S2 and S3 substances no melting point could be determined.
Key value for chemical safety assessment
Additional information
The determination of the melting point for S2 (MI3) and S3 (X14desB30) was performed using DSC in accordance to OECD guideline 102 (1995) and EC Directive 92/69/EEC Methods A1. The melting point was not determinede. The observed broad endotherm in the range 192-205 °C, probably representing a thermal transition rather than a melting point.
Therefore, the same conclusion for the target substance (Insulin Aspart Precursor) applies justified by the read-across hypothesis.
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