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Diss Factsheets
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EC number: 944-548-7 | 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
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read Across please refer to section "justification for type of information"
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 30 min
- Dose descriptor:
- EC10
- Effect conc.:
- > 500 mg/L
- Nominal / measured:
- nominal
- Key result
- Duration:
- 180 min
- Dose descriptor:
- EC10
- Effect conc.:
- > 500 mg/L
- Nominal / measured:
- nominal
- Key result
- Duration:
- 30 min
- Dose descriptor:
- EC50
- Effect conc.:
- > 500 mg/L
- Nominal / measured:
- nominal
- Key result
- Duration:
- 180 min
- Dose descriptor:
- EC50
- Effect conc.:
- > 500 mg/L
- Nominal / measured:
- nominal
- Conclusions:
- Insulin Aspart Ethyl Ester is predicted to have a toxicity to microorganisms with EC50 > 500 mg/L based on the results in the study with the source substance S2.
The microbial inhibition of Insulin Aspart Ethyl Ester is assumed to follow the same pattern as that of the source substance S2 (MI3) because of the high degree of structural similarity:
• Insulin Aspart Ethyl Ester and the source substance belong to the same chemical categories: human insulins, polypeptides and proteins
• Insulin Aspart Ethyl Ester and the source substance are both composed of polypeptide containing amino acids
The resulting EC50 values after 30 minutes and 180 minutes in the microbial inhibition study with the source substance S2 (MI3) were > 500 mg/L. - Executive summary:
The microbial inhibition of Insulin Aspart Ethyl Ester is assumed to be comparable to that of the source substance S2 (MI3) because of the high degree of structural similarity:
• Insulin Aspart Ethyl Ester and the source substance belong to the same chemical categories: human insulins, polypeptides and proteins
• Insulin Aspart Ethyl Ester and the source substance are composed of polypeptide containing amino acids
The resulting EC50 values after 30 minutes and 180 minutes in the microbial inhibition study with the source substance S2 (MI3) were > 500 mg/L. Insulin Aspart Ethyl Ester is predicted to have a toxicity to microorganisms with EC50 > 500 mg/L based on the results in the study with the source substance S2.
Furthermore, the biodegradation of the source substances: Human Insulin (S1), MI3 (S2) and X14DesB30 (S3) was studied following the OECD guideline no 301 (please refer to section 5.2.1 for details). During these studies a toxicity control was included (test concentration applied was 20 mg/L). No toxicity was observed towards microorganisms in these studies, indicating that Insulin Aspart Ethyl Ester does not inhibit microorganisms in the concentration range of 20 mg/L.
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000.08.09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
- Version / remarks:
- 1984
- Qualifier:
- according to guideline
- Guideline:
- ISO 8192 (Water quality - Test for inhibition of oxygen consumption by activated sludge for carbonaceous and ammonium oxidation)
- Version / remarks:
- 1995
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Batch no: QA204979
297 mg active ingredient/g purity 98.62% - Vehicle:
- no
- Details on test solutions:
- A stock solution of MI3 was prepared by weighing out 1,1764 g and adding deionised water up to 1000 mL.
- Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- Activated sludge collected from Nivå wastewater treatment plant, Denmark. This plant primarily receives domestic wastewater.
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 3 h
- Remarks on exposure duration:
- Recording was made after 30 minutes and 3 hours
- Post exposure observation period:
- not included
- Hardness:
- na
- Test temperature:
- 18.9-21.7°C
- pH:
- test mixtures: 7.5-8 (at the end of the test)
- Salinity:
- na
- Conductivity:
- na
- Nominal and measured concentrations:
- Test substance: 20; 50; 100; 200; 500 mg/L
Reference substance (3,5 dichlorphenol):1; 5; 25; 50; 100 mg/L - Reference substance (positive control):
- yes
- Remarks:
- 3,5-dichlorphenol
- Key result
- Duration:
- 30 min
- Dose descriptor:
- EC10
- Effect conc.:
- > 500 mg/L
- Nominal / measured:
- nominal
- Key result
- Duration:
- 180 min
- Dose descriptor:
- EC10
- Effect conc.:
- > 500 mg/L
- Nominal / measured:
- nominal
- Key result
- Duration:
- 30 min
- Dose descriptor:
- EC50
- Effect conc.:
- > 500 mg/L
- Nominal / measured:
- nominal
- Key result
- Duration:
- 180 min
- Dose descriptor:
- EC50
- Effect conc.:
- > 500 mg/L
- Nominal / measured:
- nominal
- Details on results:
- Test substance:
No inhibition was observed at the tested concentrations. The study indicated an EC50 value of > 500 mg/L. - Results with reference substance (positive control):
- EC10 (30min) <1 mg/L
EC10 (180min) = 5 (2-9) mg/L
EC50 (30min) <1 mg/L
EC50 (180min) = 5 (3-10) mg/L
EC50 values obtained in ring tests referred to in EN ISO standard are 5-30 mg/L - Validity criteria fulfilled:
- yes
- Conclusions:
- A study was conducted according to the OECD Guideline No 209: Activated sludge respiration inhibition test and EN ISO International standard 8192.
No inhibition was observed at the tested concentrations.
The study indicated that the resulting EC50 value of MI3 is > 500 mg/L after 30 minutes and after 180 minutes. - Executive summary:
A study was conducted according to the OECD Guideline No 209: Activated sludge respiration inhibition test and following EN ISO International standard 8192. No inhibition of respiration was observed at the tested concentrations.
The study indicated that the resulting EC50 value of MI3 after 30 minutes and 180 minutes is > 500 mg/L.
For the reference substance 3,5 dichlorphenol, EC10 and EC 50 were <1 mg/L (30 min) and 5 (3 -10) mg/L (180 min), respectively. EC50 values obtained in ring tests for the reference substance and referred to in EN ISO standard are 5-30 mg/L.
Referenceopen allclose all
Oxygen respiration rate of individual test mixtures was calculated applying linear regression.
EC-values for the reference substance were calculated applying the computer programme Toxedo
Description of key information
The microbial inhibition of Insulin Aspart Ethyl Ester is assumed to be comparable to that of the source substance S2 (MI3) because of the high degree of structural similarity:
• Insulin Aspart Ethyl Ester and the source substance belong to the same chemical categories: human insulins, polypeptides and proteins
• Insulin Aspart Ethyl Ester and the source substance are composed of polypeptide containing amino acids
The resulting EC50 values after 30 minutes and 180 minutes in the microbial inhibition study with the source substance S2 (MI3) were > 500 mg/L. Insulin Aspart Ethyl Ester is predicted to have a toxicity to microorganisms with EC50 > 500 mg/L based on the results in the study with the source substance S2.
Key value for chemical safety assessment
- EC50 for microorganisms:
- 500 mg/L
- EC10 or NOEC for microorganisms:
- 500 mg/L
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.