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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
Auto flammability
Administrative data
Link to relevant study record(s)
- 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 DesB30 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 DesB30) applies, justified by the read-across hypothesis.
- Executive summary:
Autoflammability of insulin DesB30 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 DesB30) applies, justified by the read-across hypothesis.
- 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
- 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.
Referenceopen allclose all
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.
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 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
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 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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