Insulin Aspart Precursor

Flash point

Link to relevant study record(s)

Reference

Reference 1

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 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 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. There is no reason to believe that whether the two amino acids chains in S1 and S3 are linked together as in T and S2, this would have any significant influence on the physical-chemical properties of the substances.

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 aspart precurser (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.

Reference 2

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 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.

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 Aspart Precursor) applies justified by the read-across hypothesis