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Physical & Chemical properties

Explosiveness

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Endpoint:
explosiveness, other
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
Parameter:
other: Differential Scanning Calorimetry
Remarks on result:
not thermal sensitive if heated under defined confinement
Interpretation of results:
GHS criteria not met
Conclusions:
No data was available for insulin human methyl ester. The explosiveness was determined based on read across to MI3 (S2). Determination of the explosive properties MI3 (source substance) was performed in accordance to EC Directive 92/69/EEC Methods A14. It is concluded that the potential for explosion is unlikely to be present based on the following three observations/results. (1) The oxygen balance was considered to be outside the region of potential concern. There are no potential auxoplose/plosophore groups present in MI3 and no thermal events was observed in the thermogram (I.e. no decomposition exotherms). Consequently, the same conclusion for the target substance (Insulin human methyl ester) applies, justified by the read-across hypothesis
Executive summary:

No data was available for insulin human methyl ester. The explosiveness was determined based on read across to MI3 (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 meltingpoint, boiling point, flammability, self-ignition, and explosion were identical.

Determination of the explosive properties MI3 (source substance) was performed in accordance to EC Directive 92/69/EEC Methods A14. It is concluded that the potential for explosion is unlikely to be present based on the following three observations/results. (1) The oxygen balance was considered to be outside the region of potential concern. There are no potential auxoplose/plosophore groups present in MI3 and no thermal events was observed in the thermogram (I.e. no decomposition exotherms). Consequently, the same conclusion for the target substance (Insulin human methyl ester) applies justified by the read-across hypothesis.

Endpoint:
explosiveness, other
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:
EU Method A.14 (Explosive properties)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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
Parameter:
other: Differential Scanning Calorimetry
Remarks on result:
not thermal sensitive if heated under defined confinement
Conclusions:
Determination of the explosive properties MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A14. MI3 is considered not to be explosive (the potential for explosion is unlikely to be present)
Executive summary:

Determination of the explosive properties MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A14. It is concluded that the potential for explosion is unlikely to be present based on the following three observations/results. (1) The oxygen balance was considered to be outside the region of potential concern. There are no potential auxoplose/plosophore groups present in MI3 and no thermal events was observed in the thermogram (I.e. no decomposition exotherms).

Description of key information

Data on target substance not available. Thus, read-across has been applied using data from source substances (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 meltingpoint, boiling point, flammability, self-ignition, and explosion were identical.

Key value for chemical safety assessment

Explosiveness:
non explosive

Additional information

Justification for classification or non-classification

Determination of the explosive properties MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A14. It is concluded that the potential for explosion is unlikely to be present based on the following three observations/results. (1) The oxygen balance was considered to be outside the region of potential concern. There are no potential auxoplose/plosophore groups present in MI3 and no thermal events was observed in the thermogram (I.e. no decomposition exotherms). Consequently, the same conclusion for the target substance (Insulin human methyl ester) applies justified by the read-across hypothesis