Insulin Aspart Precursor

Explosiveness

Link to relevant study record(s)

Reference

Reference 1

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 aspart precurser. 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 Aspart Precursor) applies justified by the read-across hypothesis

Executive summary:

No data was available for insulin aspart precurser. 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 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 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 Aspart Precursor) applies justified by the read-across hypothesis.

Reference 2

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 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 meltingpoint, boiling point, flammability, self-ignition, and explosion were identical.

Key value for chemical safety assessment

Explosiveness:

non explosive

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 Aspart Precursor) applies justified by the read-across hypothesis