Insulin Human Methyl Ester

Auto flammability

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

relative self-ignition temperature (solids)

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

Relative self-ignition temperature:

> 400 °C

Remarks on result:

no self ignition observed under the test conditions

Remarks:

No self-ignition was observed below 400°C

Conclusions:

Autoflammability of insulin human methyl ester was based on read across to MI3 (S2). Determination of the auto flammability (self-ignition) of MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A16. No relative self-ignition was observed when heating MI3 to 400 ºC, the highest temperature tested.  However, a small exothermic event was observed at 200ºC, possible releated to a thermal transition or decomposition of the MI3. Therefore, the same conclusion for the target substance (Insulin human methyl ester) applies, justified by the read-across hypothesis.

Executive summary:

Autoflammability of insulin human methyl ester was based on read across to MI3 (S2). Determination of the auto flammability (self-ignition) of MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A16. No relative self-ignition was observed when heating MI3 to 400 ºC, the highest temperature tested.  However, a small exothermic event was observed at 200ºC, possible releated to a thermal transition or decomposition of the MI3. Therefore, the same conclusion for the target substance (Insulin human methyl ester) applies, justified by the read-across hypothesis.

Reference 2

Endpoint:

relative self-ignition temperature (solids)

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.16 (Relative Self-Ignition Temperature for Solids)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL (MI3 dried)
- 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 by Sponsor)

Key result

Relative self-ignition temperature:

> 400 °C

Remarks on result:

no self ignition observed under the test conditions

Remarks:

No self-ignition was observed below 400°C

Before heating, the MI3 was a cream powder. There was small exothermic event at approximately 200°C, possible related to a thermal transition or decomposition of the MI3. There was not observed any exotherm sufficient to cause auto flammabillity (self-ignition). After heating, an expanded black residue approximately double its original volume was present in the petri at the bottom of the furnace.

Conclusions:

Determination of the auto flammability (self-ignition) of MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A16. No relative self-ignition was observed when heating MI3 to 400 ºC, the highest temperature tested.

Executive summary:

Determination of the auto flammability (self-ignition) of MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A16. No relative self-ignition was observed when heating MI3 to 400 ºC, the highest temperature tested.  However, a small exothermic event was observed at 200ºC, possible releated to a thermal transition or decomposition of the MI3.

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.

Additional information

Determination of the auto flammability (self-ignition) of MI3 (S2) was performed in accordance to EC Directive 92/69/EEC Methods A16. No relative self-ignition was observed when heating MI3 to 400 ºC, the highest temperature tested thus, no potential for self-ignition.

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