Registration Dossier

Diss Factsheets

Physical & Chemical properties

Boiling point

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
boiling point
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Remarks on result:
not determinable
Remarks:
A drop in baseline at approximately 250°C was assumed to be the start of decomposition, which would be a characteristic of a protein. It was not possible to determine the boiling point.
Conclusions:
Data on Insulin human methyl ester is not available. Thus, read-across has been applied using data from source substances (S2, S3).
As can be seen from the molecular structure. 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.
The determination of the boiling point for S2 (MI3) and S3 (X14desB30) was performed using DSC in accordance to OECD guideline 103 (1995) and EC Directive 92/69/EEC Methods A2. Boiling point was not determinede due to decomposition. Therefore, the same conclusion for the target substance (Insulin human methyl ester) applies, justified by the read-across hypothesis.
Executive summary:

Data on Insulin human methyl ester is 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 51 amino acids have at least 48 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.

The determination of the boiling point for S2 (MI3) and S3 (X14desB30) was performed using DSC in accordance to OECD guideline 103 (1995) and EC Directive 92/69/EEC Methods A2. Boiling point was not determinede due to decomposition. Therefore, the same conclusion for the target substance, Insulin human methyl ester, applies, justified by the read-across hypothesis.

Endpoint:
boiling 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 103 (Boiling Point)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.2 (Boiling 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
Decomposition:
yes
Decomp. temp.:
ca. 250 °C
Remarks on result:
not determinable
Remarks:
due to decomposition at 250°C , which is characteristic of a protein

A sudden decrease in the baseline and lower stability at approximately 250°C, which was assumed to be decomposition of the MI3 (dried), also characteristic of a protein.

 

Conclusions:
Determination of the melting temperature was performed in accordance to OECD guideline 103 (1995) and EC Directive 92/69/EEC Methods A2. The thermal behavior of MI3 (dried) was assessed by Differential Scanning Calorimetry. It was not possible to determine the boiling point.
Executive summary:

Determination of the melting temperature was performed in accordance to OECD guideline 103 (1995) and EC Directive 92/69/EEC Methods A2. The thermal behavior of MI3 (dried) was assessed by Differential Scanning Calorimetry. A drop in baseline at approximately 250°C was assumed to be the start of decomposition of MI3 (dried), which would be a characteristic of a protein.

It was not possible to determine the boiling point.

Endpoint:
boiling 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 103 (Boiling Point)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.2 (Boiling 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 (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
Key result
Decomposition:
yes
Decomp. temp.:
ca. 250 °C
Remarks on result:
not determinable
Remarks:
decomposition at approximately 250 degrees celcius

In both scans a sharp decrease in the baseline at approximately 250°C, which was assumed decomposition of the X14desB30 (dried), which is also the characteristic of a protein.

Conclusions:
Determination of the boiling point of X14desB30 was performed using DSC in accordance to OECD guideline 103 (1995). No boiling point was observed.
Executive summary:

Determination of the boiling point of X14desB30 was performed using DSC in accordance to OECD guideline 103 (1995) and EC Directive 92/69/EEC Methods A2. A sharp decrease in the baseline at approximately 250°C, which was assumed decomposition of the X14desB30 (dried), which is also the characteristic of a protein. No boiling point was observed.

Description of key information

Data on target substance is 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 51 amino acids have at least 48 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 boiling point could be determined due to decomposition.

Key value for chemical safety assessment

Additional information

The determination of the boiling point for S2 (MI3) and S3 (X14desB30) was performed using DSC in accordance to OECD guideline 103 (1995) and EC Directive 92/69/EEC Methods A2. Boiling point was not determinede due to decomposition. Therefore, the same conclusion for the target substance (Insulin human methyl ester) applies justified by the read-across hypothesis attached in section 13.