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Flash point

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Endpoint:
flash point of flammable liquids
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because decomposition occurred during the melting point study
Justification for type of information:
The molecular structure of the 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 vapour pressure determined for S2 is extremely low but consistent to what would be expected, as a single amino acid on its own has a very low vapour pressure (below 0.4 Pa) and thus, a protein of more than 50 amino acids would have an even much lower vapour pressure. Based on these data and the marginal differences in composition between the target and the source chemicals a read-across approach for physical –chemical properties using data on S1, S2 and S3 is considered scientifically justified.
Key result
Remarks on result:
not determinable, other reason:
Remarks:
The flash point of MI3 was not tested experimentally. MI3 is a proteinaceous material, which is solid at room temperature. It has negligible vapour pressure and consequently will not emit flammable vapours. This is further confirmed by the fact that no melting or boiling points could be determined.
Conclusions:
No melting or boiling points could be determined based on read across to MI3 (S2).
Executive summary:

The flash point of Insulin human methyl ester (T) was determined by read across to MI3. MI3 is a proteinaceous material, which is solid at room temperature. It has negligible vapour pressure and consequently will not emit flammable vapours. This is further confirmed by the fact that no melting or boiling points could be determined.

Endpoint:
flash point of flammable liquids
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because decomposition occurred during the melting point study

Description of key information

Data on target substance not available. Data is waived based on 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 melting point, boiling point, flammability, self-ignition, and explosion were identical.

Key value for chemical safety assessment

Additional information

The flash point of MI3 was not tested experimentally because of decomposition during determination of the melting point. MI3 (S2) and Insulin Aspart (S1) are proteinaceous materials, which are solid at room temperature. They have negligible vapour pressure and consequently will not emit flammable vapours. This is further confirmed by the fact that no melting or boiling points could be determined.

Therefore, the same conclusion for the target substance (Insulin human methyl ester) applies, justified by the read-across hypothesis