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Flammability

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Endpoint:
flammable 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
Reason / purpose for cross-reference:
read-across source
Key result
Test procedure:
burning rate test: preliminary screening test
Remarks on result:
substance does not ignite and propagate combustion either by burning with flame or smouldering along 200 mm of the powder train within the 2 minutes test period
Interpretation of results:
not classified based on GHS criteria
Conclusions:
Data on the insulin human methyl ester was not available. Therefore the result is based on read across to S2 and S3.
Determination of the flammability of X14DesB30 and MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A10. X14DesB30 and MI3 did not ignite within 2 minutes, X14DesB30(S3) and MI3(S2) are therefore not classified as highly flammable.
Consequently, the same conclusion for the target substance (Insulin human methyl ester) applies justified by the read-across hypothesis
Executive summary:

Data on the insulin human methyl ester was not available. Therefore the result is based on read across to S2 and S3.

Determination of the flammability of X14DesB30 and MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A10. X14DesB30 and MI3 did not ignite within 2 minutes, X14DesB30(S3) and MI3(S2) are therefore not classified as highly flammable.

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

Endpoint:
flammable 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.10 (Flammability (Solids))
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
Test procedure:
burning rate test: preliminary screening test
Remarks:
A full preliminary test (train test) was performed
Burning time:
ca. 2 min
Moisture (wt %):
8.28
Remarks on result:
substance does not ignite and propagate combustion either by burning with flame or smouldering along 200 mm of the powder train within the 2 minutes test period
Interpretation of results:
not classified based on GHS criteria
Conclusions:
Determination of the flammability of MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A10. MI3 did not ignite within 2 minutes and is therefore not classified as highly flammable.
Executive summary:

Determination of the flammability of MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A10. MI3 did not ignite within 2 minutes, small amounts of orange sparks was observed when the flame was applied to the pile of MI3, which blackened and expanded to approximately double its original size. Therefore, MI3 is not classified as highly flammable. In addition the average moisture content was measured to 8.28 %W/W.  

Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003.05.12 -2003.10.24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.10 (Flammability (Solids))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL (X14desB30, dried)
- Appearance: cream powder
- Source and lot/batch No.of test material: QX14203119
- Expiration date of the lot/batch: June 2004
- Purity test date: 2003-06-18
- Purity: 75% w/w
 
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Frozen below - 10°C
Key result
Test procedure:
burning rate test: preliminary screening test
Moisture (wt %):
6.36
Remarks on result:
substance does not ignite and propagate combustion either by burning with flame or smouldering along 200 mm of the powder train within the 2 minutes test period
Conclusions:
Determination of the flammability of X14desB30 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A10. X14desB30 was not found to be classified as highly flammable.
Executive summary:

Determination of the flammability of X14desB30 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A10. The average moisture content was measured to 8.28 %W/W. X14desB30 did not ignite within 2 minutes (cone and train test), small amounts of orange sparks was observed when the flame was applied to X14desB30, which slightly expanded black solid. Therefore, X14desB30 is not classified as highly flammable.

Description of key information

Data on target substance not available. Thus, read-across has been applied using data from source substances (S2 and S3).

 

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

Flammability:
not classified

Additional information

Justification for classification or non-classification

Determination of the flammability of X14DesB30 and MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A10. X14DesB30 and MI3 did not ignite within 2 minutes, X14DesB30(S3) and MI3(S2) are therefore not classified as highly flammable.

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