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EC number: 500-099-5 | CAS number: 37625-56-2
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-standard investigation; performed at a reputable laboratory and reported in detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
- Objective of study:
- absorption
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study investigated the absorption of CAPA 3050 in vitro in a rat gut sac model
- GLP compliance:
- no
Test material
- Reference substance name:
- CAPA 3050
- IUPAC Name:
- CAPA 3050
- Reference substance name:
- ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol
- EC Number:
- 500-099-5
- EC Name:
- ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol
- Cas Number:
- 37625-56-2
- Molecular formula:
- (C6H14O3)x.C6H10O2 (x=0-6)
- IUPAC Name:
- 2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol
- Reference substance name:
- 2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1, 3-propanediol
- IUPAC Name:
- 2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1, 3-propanediol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): CAPA 3050
- Substance type: Oligomer
- Physical state: Liquid
- Analytical purity: 100%
- Lot/batch No.: WCB000999
- Expiration date of the lot/batch: 23th August 2015
- Stability under test conditions: Stable for the duration of the study
- Storage condition of test material: Ambient
Constituent 1
Constituent 2
Constituent 3
- Radiolabelling:
- no
Test animals
- Species:
- other: not relevant
Administration / exposure
- Route of administration:
- other: In vitro
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Gut (small intestine) sacs were prepated from male Han Wistar rats. The everted gut sacs were placed in a flask of 10 mL FeSSIF (Fed State Simulated Intestinal Fluid) medium containing 10 mM of CAPA 3050 at 37°C. The sacs from one rat were incubated in triplicate at 37°C for 1 hour. After 1 hour the individual sacs were removed, washed with running water and blotted dry.
- Duration and frequency of treatment / exposure:
- One hour incubation
Doses / concentrations
- Remarks:
- Doses / Concentrations:10 mM
- No. of animals per sex per dose / concentration:
- The sacs from one rat were incubated in triplicate at 37°C for 1 hour.
- Control animals:
- no
- Positive control reference chemical:
- Not required
- Details on study design:
- The everted intestinal sacs were prepared by gently everting a freshly excised (male Han Wistar) rat proximal small intestine over a glass stirring rod, rinsing with TC-199 media and filling the everted intestine withoxygenated FeSSIF medium at 37°C and dividing it into sacs approximately 2.5 cm in length using braided suture silk. Each sac was placed in a flask of 10mL FeSSIF medium containing 10mM of CAPA 3050 at 37°C. The sacs from one rat were incubated in triplicate at 37°C for 1 hour. After 1 hour the individual sacs were removed, washed with running water and blotted dry. The sacs were cut open and the serosal fluid drained into small tubes. Each tube was weighed before and after collection of the serosal fluid to accurately calculate the volume of medium collected from inside the sac.
- Details on dosing and sampling:
- The contents of each sac and a sample of the external medium after incubation (400µL) were blown down to complete dryness under nitrogen at 90°C. 200µL of N,N-bis-trimethylsilyl-trifluoroacetamide (BSTFA) was added to each sample followed by 800 µL of pyridine and capped. The samples were then sonicated in a sonicating water bath for approximately 10 seconds to ensure mixing and reconstitution. The samples were then heated at 105°C for 30 minutes. A 150µL aliquot of the reconstituted sample was removed and placed in a crimp-top vial for analysis by Gas Chromatography Flame Ionisation Detection (GC-FID) to determine the concentration of the CAPA 3050 in each sample and compared against analytical standards.
- Statistics:
- Not required
Results and discussion
- Preliminary studies:
- The results of the study showed a different peak distribution in the serosal and external media compared to the standard. For Component 1 (TMP), the peaks in the serosal and external fluid were higher than the standard. For Component 2, the serosal fluid peak was slightly higher than the standard and the external fluid peak was comparable to the standard. For Component 3, the serosal peak was markedly lower than the external medium concentration. Components 4-8 were not detected in the serosal medium. Concentrations in the external medium were lower than the standard.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Although the study was not designed to assess metabolism, the change in peak profile is consistent with some hydrolysis of the CAPA 3050 oligomers to produce TMP [Component 1]
Any other information on results incl. tables
Summary of results
Component |
Mean peak area |
|||
Standard |
External medium |
Serosal medium |
||
#1 |
TMP |
6742 |
10304 |
10601 |
#2 |
TMP + 1eCL |
13256 |
13289 |
14725 |
#3 |
TMP + 2eCL |
17515 |
15116 |
2749 |
#4 |
TMP + 3eCL |
20634 |
6595 |
37 |
#5 |
TMP + 4eCL |
8968 |
2486 |
- |
#6 |
TMP + 5eCL |
2952 |
307 |
- |
#7 |
TMP + 6eCL |
- |
- |
- |
#8 |
TMP + 7eCL |
- |
- |
- |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
- Executive summary:
The aim of this study was to determine the rat small intestinal absorption potential of CAPA 3050 using an in vitro everted gut sac model. From the results it can be concluded that the lower molecular weight components of CAPA 3050 (TMP > TMP+1ECL > TMP+2ECL > TMP+3ECL) were absorbed into the serosal fluid. This would imply a negative correlation between the molecular weight of the components of CAPA 3050 and the rat small intestinal absorption potential. It was also noted that the concentrations of components 4 to 6 were greatly reduced in the external medium after the 60 minute incubation at 37°C when compared to the 10 mM standard. The reasons for this drop in concentration are unclear, but it has been suggested that a possible reason could be hydrolysis of the higher molecular weight components of CAPA 3050 and conversion to TMP. Another possible reason could be the low water solubility of the higher molecular weight components.
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