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EC number: 283-518-1 | CAS number: 84650-59-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Illicium verum, Illiciaceae.
- 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
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (E)-anethole
- EC Number:
- 224-052-0
- EC Name:
- (E)-anethole
- Cas Number:
- 4180-23-8
- Molecular formula:
- C10H12O
- IUPAC Name:
- 1-methoxy-4-prop-1-en-1-ylbenzene
- Reference substance name:
- 4-allylanisole
- EC Number:
- 205-427-8
- EC Name:
- 4-allylanisole
- Cas Number:
- 140-67-0
- Molecular formula:
- C10H12O
- IUPAC Name:
- 1-allyl-4-methoxybenzene
- Reference substance name:
- Caryophyllene
- EC Number:
- 201-746-1
- EC Name:
- Caryophyllene
- Cas Number:
- 87-44-5
- Molecular formula:
- C15H24
- IUPAC Name:
- 4,11,11-trimethyl-8-methylenebicyclo[7.2.0]undec-4-ene
- Reference substance name:
- 2,6-dimethyl-6-(4-methyl-3-pentenyl)bicyclo[3.1.1]hept-2-ene
- EC Number:
- 241-702-9
- EC Name:
- 2,6-dimethyl-6-(4-methyl-3-pentenyl)bicyclo[3.1.1]hept-2-ene
- Cas Number:
- 17699-05-7
- Molecular formula:
- C15H24
- IUPAC Name:
- 2,6-dimethyl-6-(4-methylpent-3-en-1-yl)bicyclo[3.1.1]hept-2-ene
- Test material form:
- liquid
Constituent 1
Constituent 2
1
Constituent 3
- Radiolabelling:
- no
Study design
- Details on sampling:
- Test item: Essential oil of Star Anise Oil (Illicium verum) (1)
Received on: 17/May/2018
Bioagri code: QUIM-0014/18
Analyzed Concentration of a.i. (Bioagri): 96.32% (m/m)
Analysis Certificate (CA): CA TH - 0461/17
Batch number: 18-02-10-1 (1)
Physical state: Light yellow clarified liquid or crystal (1)
Homogeneity data: Homogeneous sample (CA TH - 0461/17)
Manufacture Date: 10/Feb/2018 (1)
Validity Date: 09/Aug/2019 (1)
Manufacturer: Jinxi County Purong Essences MFG Co., Ltd (1)
Address: JiangXi Jinxi County Industrial Park Area C (1)
Source: (1) Information provided by the sponsor. - Buffers:
- pHs 4, 7, 9 and 10 sterilized buffers (buffer solution of pH 10 was used only for calibration of pHmeter);
Ultrapure water (sterilized);
Phosforic acid PA - Purity: 85%;
Acetonitrile HPLC grade - Purity: 99.9%;
Ethanol HPLC grade - Purity: 99.9%;
TSA - Tryptone Soya Agar;
SAB - Sabouraud Dextrose Agar.
Duration of testopen allclose all
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 3.48 other: μg/ml
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 4.7 other: μg/ml
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 3.58 other: μg/ml
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
Results and discussion
- Preliminary study:
- The concentrations of the test item in the solutions prepared for the preliminary test were determined by the HPLC/DAD method described in section 7.1. The analytical method was calibrated by a set of solutions prepared from the reference item. The representative chromatogram of the reference item is shown in Figure 2.
All sets of calibration data were prepared using the reference item at concentrations above and below the nominal concentration and showed excellent linear correlations between the active ingredient concentration and the peak area of the chromatograms. The correlation coefficient for the calibration curve was 0.99 (Figure 1). Thus, the HPLC/DAD method described in section 7.1. was suitable for this study.
Representative chromatograms of the buffers solutions without application of the test item are showed in Figure 3 for pH 4, Figure 4 for pH 7 and Figure 5 for pH 9.
The results of the initial concentration determination, and those performed after 5 days of incubation at 50 ± 0.5oC are presented in Table 5. Figure 6 show a graphic with the variation of temperature during the incubation period. The results of the preliminary test showed that the test item concentration decreased for all tested pH, indicating that the test item is unstable at pHs 4, 7 and 9. Figures 7 and 8 show the chromatograms obtained for pH 4, Figures 9 and 10 show the chromatograms obtained for pH 7, Figures 11 and 12 the chromatograms obtained for pH 9.
To confirm that the peaks observed in the initial and final chromatograms are due solely to the test item, purities were calculated. The results of the purity index calculation, performed by the software of the chromatography workstation, for pHs 4, 7 and 9 buffered solutions following 5 days of incubation returned values above 99%, indicating no co-elution. The results are shown in Figure 13 for pH 4, Figure 14 for pH 7 and Figure 15 for pH 9. - Transformation products:
- not measured
Total recovery of test substance (in %)open allclose all
- % Recovery:
- ca. 97.94
- St. dev.:
- 4.19
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- ca. 5 d
- % Recovery:
- ca. 97.94
- St. dev.:
- 4.19
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- ca. 5 d
- % Recovery:
- ca. 97.94
- St. dev.:
- 4.19
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- ca. 5 d
Dissipation DT50 of parent compoundopen allclose all
- Key result
- pH:
- 4
- Temp.:
- 50 °C
- Remarks on result:
- other: The test item in function of pH is considered unstable, therefore, a definitive test (Tier II) is required to determine the half-life of the test item.
- Key result
- pH:
- 7
- Temp.:
- 50 °C
- Remarks on result:
- other: The test item in function of pH is considered unstable, therefore, a definitive test (Tier II) is required to determine the half-life of the test item.
- Key result
- pH:
- 9
- Temp.:
- 50 °C
- Remarks on result:
- other: The test item in function of pH is considered unstable, therefore, a definitive test (Tier II) is required to determine the half-life of the test item.
- Details on results:
- According to the results of Tier I, the Essential oil of Star Anise Oil (Illicium verum) test item degraded more than 10% of the initial concentration at 50 ± 0.5°C at pHs 4, 7 and 9. The test item in function of pH is considered unstable, therefore, a definitive test (Tier II) is required to determine the half-life of the test item.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- According to the results of Tier I, the Essential oil of Star Anise Oil (Illicium verum) test item degraded more than 10% of the initial concentration at 50 ± 0.5°C at pHs 4, 7 and 9. The test item in function of pH is considered unstable, therefore, a definitive test (Tier II) is required to determine the half-life of the test item.
- Executive summary:
A study of the hydrolysis ofEssential oil of Star Anise Oil (Illicium verum)performed by Tier I, has been conducted at pHs 4, 7 and 9. In a preliminary test conducted at 50 ± 0.5oC, it was found that at pHs 4, 7 and 9,the test itemconcentration decrease more than 10% during an incubation period of 5 days, from the initial concentration. The test itemin function of pH is considered unstable for the pHs 4, 7 and 9 and a definitive test (Tier II) is required.
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