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EC number: 283-298-7 | CAS number: 84604-20-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Silybum marianum, Compositae.
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Not specified
- Principles of method if other than guideline:
- The objective of this study was to evaluate the basal cytotoxicity of the test item, applied to mouse fibroblasts (Balb/c 3T3, clone A 31 and using the. Cytotoxicity is measured as the inhibition of the capacity to take up the vital dye, Neutral Red (NR). NR readily penetrates cell membranes by non-diffusion and accumulates in the cell lysosomes. Damage to the lysosomal membrane leads to irreversible lysosome fragility. Damage to lysosomes by a test item results in a decrease in the uptake and accumulation of NR, allowing the quantification by spectrophotometry of viable, damaged or dead cells. The NRU assay is performed in a dose-response format allowing the calculation of the concentration of the test item that reduces the neutral red uptake (NRU) by 50% (IC50), when applicable.
- GLP compliance:
- no
- Remarks:
- The study was stopped, no treatment of main test was performed and the GLP status was removed.
- Test type:
- other: 3T3 NRU Test
- Limit test:
- no
Test material
- Reference substance name:
- Silybum marianum, ext.
- EC Number:
- 283-298-7
- EC Name:
- Silybum marianum, ext.
- Cas Number:
- 84604-20-6
- Molecular formula:
- Not available - UVCB substance
- IUPAC Name:
- Extract of Chardon marie without support
- Test material form:
- liquid
- Details on test material:
- Name: Extract of Chardon marie without support
Batch/Lot number: VDO06205A
Appearance: Light yellow brown cloudy oil
Purity: Considered as 100%
Retest date: 13 July 2019
Storage conditions: Refrigerated
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personnel health and safety.
Name: Extract of Chardon marie without support
Batch/Lot number: ABT01059A
Appearance: Brown/orange turbid oil
Purity: Considered as 100%
Retest date: 19 July 2018
Storage conditions: Refrigerated
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personnel health and safety.
Reference: MPB-693061 / MPF-00024688
Batch number: VDO06126E
Provider: Pierre Fabre
Reference: GD 1508
Certificate of analysis: Yes
MSDS: Yes
Type: Raw material
Form: Liquid
Nature: Complex mixture
Colour: Yellowish
Storage conditions: Stored at room temperature
Requested test conditions: To be tested at 100 % (as is)
Sent quantity: 10 g
Expiry / Retest date: 27 November 2016
1
- Specific details on test material used for the study:
- No further details specified in the study report.
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Mouse fibroblasts (Balb/c 3T3, clone A 31) - no further details specified in the study report.
Administration / exposure
- Route of administration:
- other: Not applicable
- Vehicle:
- ethanol
- Details on oral exposure:
- Not applicable
- Doses:
- During the assay, eight concentrations of test item were tested using six replicates per concentration. These concentrations were spaced using a decimal geometric dilution factor of 10. Eight concentrations of the positive control were also applied to the cells in parallel.
- No. of animals per sex per dose:
- Not specified
- Control animals:
- yes
- Remarks:
- Positive control in parallel
- Details on study design:
- The objective of the study was to evaluate the basal cytotoxicity of the test item, applied to mouse fibroblasts (Balb/c 3T3, clone A 31 and using the 3T3 NRU test. Cytotoxicity is measured as the inhibition of the capacity to take up the vital dye, Neutral Red (NR). NR readily penetrates cell membranes by non-diffusion and accumulates in the cell lysosomes. Damage to the lysosomal membrane leads to irreversible lysosome fragility. Damage to lysosomes by a test item results in a decrease in the uptake and accumulation of NR, allowing the quantification by spectrophotometry of viable, damaged or dead cells.
A solubility assay was performed in order to evaluate the solubility of the test item among the vehicles DMEM0, DMSO or ethanol.
A solubility evaluation in DMEM0 containing 1% of vehicle was also performed once solution was achieved in a vehicle.
A preliminary test was performed prior to the main tests to determine the relevant concentration range at which cytotoxicity is obtained. During this assay, eight concentrations of test item were tested using six replicates per concentration. These concentrations were spaced using a decimal geometric dilution factor of 10. Eight concentrations of the positive control were also applied to the cells in parallel. - Statistics:
- Not specified
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- LD50
- Remarks on result:
- not determinable because of methodological limitations
- Mortality:
- Not specified
- Clinical signs:
- other: Not specified
- Gross pathology:
- Not specified
- Other findings:
- Solubility
The test item was found not soluble in culture medium at 2, 20 and 200 mg/mL, in DMSO at 20 and 200 mg/mL and in ethanol at 200 mg/mL.
A solution was reached once test item was prepared in ethanol at 20 mg/mL after at least 5 minutes of vortex. A solution was still obtained after a 100-fold dilution in culture medium. As a result, ethanol was the retained vehicle and the highest final tested concentration to be used in the preliminary test was 100 μg/mL.
Preliminary test
Due to test item limit of solubility and therefore the low tested concentration (i.e. 100 μg/mL in culture medium containing 0.5% ethanol), no cytotoxicity was reached at the end of this preliminary test. Since the aim of this study cannot be achieved (i.e. no IC50 and therefore no LD50 can be determined), it was agreed with the Sponsor to stop the study as it is. Indeed, solubility is a limitation to this type of assay.
Consequently this study was stopped, no treatment of main test was performed and the GLP status was removed.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the experimental conditions of the study, due to the test item limit of solubility (i.e. 100 μg/mL in DMEM0 containing 0.5% ethanol) and the fact that no cytotoxicity was achieved after the preliminary test, this study was stopped at this stage. It was not possible to derive any IC50 and therefore any LD50.
- Executive summary:
The objective of this study was to evaluate the basal cytotoxicity of the test item, applied to mouse fibroblasts (Balb/c 3T3, clone A 31 and using the 3T3 NRU test. Cytotoxicity is measured as the inhibition of the capacity to take up the vital dye, Neutral Red (NR). NR readily penetrates cell membranes by non-diffusion and accumulates in the cell lysosomes. Damage to the lysosomal membrane leads to irreversible lysosome fragility. Damage to lysosomes by a test item results in a decrease in the uptake and accumulation of NR, allowing the quantification by spectrophotometry of viable, damaged or dead cells. The NRU assay is performed in a dose-response format allowing the calculation of the concentration of the test item that reduces the neutral red uptake (NRU) by 50% (IC50), when applicable. The IC50 value could then be used in a linear regression equation to estimate the oral LD50 value in rats. However, and due to test item limit of solubility, the objective of this study cannot be achieved since no cytotoxicity was reached after the preliminary test.
Under the experimental conditions of this study, due to the test item limit of solubility (i.e. 100 μg/mL in DMEM0 containing 0.5% ethanol) and the fact that no cytotoxicity was achieved after the preliminary test, this study was stopped at this stage. It was not possible to derive any IC50 and therefore any LD50.
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