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Density

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Endpoint:
relative density
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
Key result
Type:
relative density
Density:
ca. 1.342 kg/m³
Temp.:
20.1 °C
Remarks on result:
other:
Remarks:
Standard deviation of 0.0038
Conclusions:
Data on target substance not available. Thus, read-across has been applied using data from source substance (S2).
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 relative density for S2 (MI3) was performed using DSC in accordance to OECD guideline 109 (1995) and EC Directive 92/69/EEC Methods A3. The relative density of MI3 (dried) was determined to be 1.342.± 0.0038 kg/m3at 20.1oC. Therefore, the same conclusion for the target substance (Insulin human methyl ester) applies justified by the read-across hypothesis.
Executive summary:

Data on target substance not available. Thus, read-across has been applied using data from source substance (S2).

 

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 the relative density of MI3 (dried) was determined to be 1.342.± 0.0038 kg/m3at 20.1oC

The determination of the relative density for S2 (MI3) was performed using DSC in accordance to OECD guideline 109 (1995) and EC Directive 92/69/EEC Methods A3. The relative density of MI3 (dried) was determined to be 1.342.± 0.0038 kg/m3at 20.1oC. Therefore, the same conclusion for the target substance (Insulin human methyl ester) applies justified by the read-across hypothesis.

Endpoint:
relative density
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 109 (Density of Liquids and Solids)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.3 (Relative Density)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
air comparison pycnometer (for solids)
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
Dynamic viscosity of test material:
NA
Key result
Type:
relative density
Density:
ca. 1.342 kg/m³
Temp.:
20.1 °C
Remarks on result:
other:
Remarks:
a Standard deviation of 0.0038

The calibration showed that the cell volume was within acceptable limits. The test temperature was 20.1°C. The sample cell volume was 37.9654 cm3. The expansion cell volume was 74.4377 cm3. The weight of MI3 (dried) 9.5727 g. The mean density was 1.342 kg/m3, with a standard deviation of 0.0038.

Conclusions:
The density of MI3 (dried) was determined by a gas comparison pyknometer method. The procedure conformed with EC Directive 92/69/EEC Method A3, and OECD Guideline 109 (1995). The relative density [D420] (dimensionless) of MI3 (dried) was determined to be 1.342 (σ,n-1 0.004).
Executive summary:

The density of MI3 (dried) was determined by a gas comparison pyknometer method. The procedure conformed with EC Directive 92/69/EEC Method A3, and OECD Guideline 109 (1995). The relative density [D420] (dimensionless) of MI3 (dried) was determined to be 1.342 (σ(n-1) 0.004). The Relative Density as a D420value was calculated by dividing the density value (in g/mL) of MI3 (dried) by the value of the density of water at 4°C.

Description of key information

Data on target substance not available. Thus, read-across has been applied using data from source substance (S2).

 

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 the relative density of MI3 (dried) was determined to be 1.342.± 0.0038 kg/m3at 20.1oC

Key value for chemical safety assessment

Relative density at 20C:
1.342

Additional information

The determination of the relative density for S2 (MI3) was performed using DSC in accordance to OECD guideline 109 (1995) and EC Directive 92/69/EEC Methods A3. The relative density of MI3 (dried) was determined to be 1.342.± 0.0038 kg/m3at 20.1oC. Therefore, the same conclusion for the target substance (Insulin human methyl ester) applies justified by the read-across hypothesis.