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Diss Factsheets
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EC number: 944-550-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Flammability
Administrative data
Link to relevant study record(s)
- 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 DesB30 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 DesB30) applies justified by the read-across hypothesis - Executive summary:
Data on the insulin DesB30 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 DesB30) 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.
Referenceopen allclose all
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 50 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
- 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 DesB30) applies, justified by the read-across hypothesis
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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