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EC number: 908-114-0 | 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March-June 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
- Objective of study:
- other: hydrolysis and degradation of geranylacetate extra in plasma, liver and gastrointestinal tract
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The hydrolysis and degradation of Geranyl acetate Extra in plasma, liver and gastrointestinal tract was investigated. To determine hydrolysis in either compartment, the test substance was incubated with plasma and liver-S9 fraction from rat as well as in gastric-juice simulant and intestinal-fluid simulant. After incubation, the proteins were precipitated and the amount of remaining substrate was analysed in the supernatant by GC/FID.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid
- Details on test material:
- CAS 105-87-3
- Radiolabelling:
- no
Test animals
- Species:
- other: not applicable; in vitro test
Administration / exposure
- Statistics:
For calculation of the hydrolysis (turn over), peak areas of the substrates of active incubation (AI) and heat deactivated control (HDC) were used. Buffer controls were used to calculate the substrate recovery of the HDC and t=0 control.
Calculation of the turn over in plasma, liver- S9 fraction and intestine-fluid simulant:
% turn-over = 100 * (peak area (HDC) – peak area (AI)) / peak area (HDC)
Calculation of the turn-over in gastric-juice simulant:
% turn-over = 100 * (peak area (t=0) – peak area (AI)) / peak area (t=0)
Results and discussion
Any other information on results incl. tables
Geranylacetate Extra hydrolyzed within 0.5h almost completely in rat plasma, liver S9 fraction of rats and intestinal- fluid simulant under the test conditions used. Hydrolysis was demonstrated by the decrease of Geranylacetate Extra as well as by the formation of its hydrolysis product Geraniol Extra. Although the recovery of Geranylacetate Extra was tentatively low in respective controls, the quantitative amount of Geraniol Extra formed was correlated to the nominal substrate concentration of Geranylacetate in incubates and proved a high metabolic turn over. It is assumed that the low recoveries of Geranylacetate in HDC controls are based on potential evaporation of the test substance. In t=0 controls, low recoveries are due to partial hydrolysis, since Geraniol Extra is generally already detectable
in these controls, proving that hydrolysis was faster than the stopping process after addition of the test substance to the system. In gastric fluid simulant, the degradation of Geranylacetate Extra was slower and was calculated to be about 50 % after an incubation period of 2h. The degradation of Geranylacetate Extra yielded maximum degradation rates of ≥211.8 [μmol/L*h], ≥2.7 [μM/g liver equivalent*h], ≥21.3 [μM/g pancreas lipase (15-35 U/mg)*h] and 93.2 [μmol/L*h] for rat plasma, liver S9 fraction of rats, intestinal fluid simulant containing 1 weight% pancreas lipase and gastric fluid simulant, respectively. These maximum degradation rates of Geranylacetate Extra were in the same order of magnitude than the maximum degradation rates determined for the applied positive control Benzyl benzoate and demonstrate a fast hydrolysis of Geranylacetate Extra in gastrointestinal tract, liver and plasma.
Applicant's summary and conclusion
- Conclusions:
- The current in vitro data demonstrate that Geranylacetate Extra is hydrolyzed within 0.5 h to Geraniol almost completely in rat plasma, liver S9 fraction of rats and intestinal- fluid simulant under the test conditions used. In gastric fluid simulant the degradation of Geranylacetate Extra was slower and was calculated to be about 50 % after an incubation period of 2 h. The degradation of Geranylacetate Extra yielded maximum degradation rates of ≥211.8 [μmol/L*h], ≥2.7 [μM/g liver equivalent*h], ≥21.3 [μM/g pancreas lipase (15-35 U/mg)*h] and 93.2 [μmol/L*h] for rat plasma, liver S9 fraction of rats, intestinal fluid simulant containing 1 weight% pancreas lipase and gastric fluid simulant, respectively. These maximum degradation rates of Geranylacetate Extra were in the same order of magnitude as the maximum degradation rates determined for the positive control Benzyl benzoate.
- Executive summary:
To determine hydrolysis in either compartment, the test substance was incubated in duplicates at a nominal concentration of 250 μM for 0.5, 1 and 2h at 37°C in plasma, liver S9 fraction of rats, gastric-juice simulant and intestinal-fluid simulant including pancreas lipase. After incubation, proteins in incubates were precipitated by the addition of one volume acetone and the amount of remaining
substrate was analysed in the supernatant by GC/FID. Heat deactivated controls (HDC, with the exception of gastric juice simulant) and controls, directly stopped after addition of test substance (t=0 control) served as control samples. A buffer control or medium (BC, test substance in the incubation buffer; MC, test substance in the incubation medium) was used for calculation of recoveries in the HDC and t=0 controls. Additionally recovery of controls was related to the target concentration of the test substance in the in vitro incubate (250 μM).
Positive controls were performed with Benzyl benzoate at a concentration of 250μM. In rat plasma and liver S9 fraction of rats, Benzyl benzoate was hydrolyzed after 0.5 h almost completely, resulting in a metabolic turnover of 97 and 99%, respectively. In the in vitro systems of gastrointestinal tract, hydrolysis was slower, yielding maximum metabolic turn over values of 43 and 51 % after 2h for intestine fluid simulant and gastric fluid simulant, respectively. The maximum degradation rates of Benzyl benzoate were ≥182.3 [μmol/L*h], ≥4.9 [μM/g liver equivalent*h], 27.6 [μM/g pancreas lipase (15-35 U/mg)*h] and 84.6 [μmol/L*h] for rat plasma, liver S9 fraction of rats, intestinal fluid simulant containing 1 weight% pancreas lipase and gastric fluid simulant, respectively. Based on these results, the validity of the applied in vitro systems as well as of the chosen incubation conditions was clearly demonstrated.
The current in vitro data demonstrate that Geranylacetate Extra is hydrolyzed within 0.5 h to Geraniol almost completely in rat plasma, liver S9 fraction of rats and intestinal- fluid simulant under the test conditions used. In gastric fluid simulant the degradation of Geranylacetate Extra was slower and was calculated to be about 50 % after an incubation period of 2 h. The degradation of Geranylacetate Extra yielded maximum degradation rates of ≥211.8 [μmol/L*h], ≥2.7 [μM/g liver equivalent*h], ≥21.3 [μM/g pancreas lipase (15-35 U/mg)*h] and 93.2 [μmol/L*h] for rat plasma, liver S9 fraction of rats, intestinal fluid simulant containing 1 weight% pancreas lipase and gastric fluid simulant, respectively.
These maximum degradation rates of Geranylacetate Extra were in the same order of magnitude as the maximum degradation rates determined for the positive control Benzyl benzoate.
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