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EC number: 254-409-6 | CAS number: 39300-88-4 Extractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerization products of these terpenes. Caesalpinia, Leguminosae.
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tara gum
- EC Number:
- 254-409-6
- EC Name:
- Tara gum
- Cas Number:
- 39300-88-4
- IUPAC Name:
- Oligosaccharides of Caesalpinia Spinosa extract
- Test material form:
- liquid
- Details on test material:
- Aqueous yellow liquid
Constituent 1
Method
- Target gene:
- histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- N/A
- Additional strain / cell type characteristics:
- not applicable
- Cytokinesis block (if used):
- N/A
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% S9: S9-mix from the livers of rats
- Test concentrations with justification for top dose:
- The solubility test showed no insolubility of the test item. Therefore, the maximal concentration retained was 5000 μg/plate.
According to OECD Guideline, 5 concentrations of test item have been studied with approximately halflog (i.e. approximately √10) interval. These doses (rounded to the higher value) used for the preliminary cytotoxicity test were therefore the following: 5000, 1600, 500, 160 and 50 μg/plate.
As the preliminary experiment revealed no cytotoxicity of the test item, this range of concentrations has been conserved for the Test 1.
According to the results obtained in the Test 1, the Study Director decided to maintain range of concentrations for Test 2.
Each test item dilution and each reference item are tested on 3 Petri plates. - Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: The test substance was soluble in water.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water or DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Remarks:
- without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9
- Details on test system and experimental conditions:
- Preliminary cytotoxicity study
The preliminary cytotoxicity study of the test item has been performed on the strain S. typhimurium TA100, in the same conditions as the Test 1.
Results obtained are part of the Test 1 results if no cytotoxicity is observed. The test item has been dissolved in the suitable solvent.
The applied protocol was the following one:
• In 3 hemolysis tubes, introduce:
o assay without metabolic activation:
0.5 ml sterile phosphate buffer 0.2 M, pH 7.4,
0.1 ml of the different test item concentrations,
2 ml of top agar,
0.1 ml of bacterial inoculum (TA100).
o assay with metabolic activation:
0.1 ml of the different test item concentrations,
2 ml of top agar,
0.1 ml of bacterial inoculum (TA100),
0.5 ml of S9-Mix.
• Mix and pour on the surface of the bottom agar previously distributed in Petri dishes.
• Incubate at 37 °C (± 1 °C) for 48 to 72 hours.
Test itself: Research of mutagenic activity
For at least 5 concentrations of the test item, a test without metabolic activation and a test with metabolic activation have been performed simultaneously as follow:
Test 1: direct method
• For each strain, in 3 hemolysis tubes, introduce:
o assay without metabolic activation:
0.5 ml sterile phosphate buffer 0.2 M, pH 7.4,
0.1 ml of the different test item concentrations,
2 ml of top agar
Test 2: method with pre-incubation
Pre-incubation method allows revealing more effectively mutagen activity of some compounds like
aliphatic nitrosamines, bivalent metals, aldehydes, azoic coloring agent.
The applied protocol was the following one:
• For each strain, in 3 hemolysis tubes, introduce:
o assay without metabolic activation:
0.5 ml sterile phosphate buffer 0.2 M, pH 7.4,
0.1 ml of the different test item concentrations,
0.1 ml of bacterial inoculum.
o assay with metabolic activation:
0.1 ml of the different test item concentrations,
0.1 ml of bacterial inoculum,
0.5 ml of S9-Mix.
• Incubate at 37°C (± 1°C) for 20 to 30 min.
• Add the 2 ml of top agar.
• Mix and pour on the surface of the bottom agar previously distributed in Petri dishes.
• Incubate at 37°C (± 1°C) for 48 to 72 hours.
0.1 ml of bacterial inoculum.
o assay with metabolic activation:
0.1 ml of the different test item concentrations,
2 ml of top agar,
0.1 ml of bacterial inoculum,
0.5 ml of S9-Mix.
• Mix and pour on the surface of the bottom agar previously distributed in Petri dishes.
• Incubate at 37°C (± 1°C) for 48 to 72 hours. - Rationale for test conditions:
- For each assay the following observations were performed and reported:
• Observation of the reagent mix before Petri plates pouring: reporting of any abnormal sign (precipitate, trouble, etc.),
• Petri plates observation and reporting of any cytotoxicity sign (bottom bacterial layer reduction). The cytotoxicity intensity on the bottom bacterial layer is evaluated qualitatively on each plate by naked eyes:
o total destruction of the bottom bacterial layer (the revertants development does not occurs in this case), this one is noted in tables of results as “A”.
o moderated destruction of the bottom bacterial layer. This one is noted in tables of results as “S”.
Acquisition and storage of raw data were managed by the following electronic system:
Reading of plates: Sorcerer, version 2.2.
Transfer and storage of raw data: Ames Study Manager, version 1.22. - Evaluation criteria:
- The test is considered valid if the following criteria are fulfilled:
The sterility tests are conform,
The mean negative controls are within the historical data,
The solvent used (negative control) must not show genotoxic nor cytotoxic activity,
The revertants rate obtained for the positive controls must be in agreement with the historical data,
The positive controls must show a revertants number equal at least to the double of the spontaneous rate of reversion for TA98, TA100 and TA102 (R ≥ 2) and the triple of the spontaneous rate of reversion for TA1535 and TA1537 (R ≥ 3),
No more than 5% of the plates of the test are lost through contamination or any other unforeseen event,
At least 3 concentrations are available for mutagenicity assessment.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA98, TA100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Revertant analysis tables show that:
No cytotoxic effect was observed,
No concentration of the test item showed ratio R higher or equal at least to the double of the spontaneous rate of reversion for TA98, TA100 and TA102 strains and to the triple of the spontaneous rate of reversion for TA1535 and TA1537 strains, with and without metabolic activation,
No dose response was observed, whatever the test system or conditions of the test.
In addition, no sign of precipitate was observed.
Applicant's summary and conclusion
- Conclusions:
- Based on the result of this study, the test item was found to be non mutagenic and non pro-mutagenic under the test conditions.
- Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100 and TA102) were exposed to test item at the following concentrations: 50, 160, 500, 1600 and 5000μg/plate.
Based on the result of this study, the test item was found to be non mutagenic and non pro-mutagenic under the test conditions.
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