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EC number: 946-767-3 | 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
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:
- April 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- N/A
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Saccharides of mannose and galactose from Ceratonia Siliqua seed
- IUPAC Name:
- Saccharides of mannose and galactose from Ceratonia Siliqua seed
- Test material form:
- liquid
- Details on test material:
- Clear yellow
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
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% S9: S9 fraction from Aroclor induced rats (Moltox, USA)
- Test concentrations with justification for top dose:
- Main test : 5 μL, 1.5μL, 0.5 μL, 0.15μL and 0.05μL
Confirmation test: same concentrations of test item with adding of PBS with or without metabolic activation system mix (S9) - Vehicle / solvent:
- Water
Justification for choice of solvent/vehicle: The test substance was soluble in water.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Control cultures were trated with solvent
- Negative solvent / vehicle controls:
- no
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Remarks:
- Control cultures were treated with solvent
- Negative solvent / vehicle controls:
- no
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With S9
- Details on test system and experimental conditions:
- Solubility test: Solubility was assessed as precipiation in the final mixture under the actual test conditions. Observation of precipitation by naked eye indicates insolubilty.
Cytotoxicity test: A potential cytotoxicity effect of the test item that would interfere in the results was ruled out with the following test: 5 concentrations and a negative control of test item were tested in Salmonella typhimurium TA100. The test item was mixed with top agar containing 2.5 mM Histidine/Biotine. The solution was then added to a plate containing mineral agar and incubated at 37°C for 72hours.
Inhibition of growth by the test item suggests a cytotoxicity activity. A cytotoxicity effect a high concentrations only would require lower concentration of the test item in the main test.
Test performance: Cultures of bacteria were incubated overnight with nutrient broth up to an absorbance (60 nm) of approximately 1.2-1.4 OD. This OD indicates that bacteria are growing in the late exponential or early stationary phase of growth (approx. 10^9 bacteria/ml).
Plates were prepared with minimal agar medium . Medium was mixed and preheated to about 45°C and then poured into the plate and cooled at room temperature.
Each bacterial strain was tested by triplicate in the presence and absence of the metabolic system (S9). The bacterial suspension, the test item and PBS (-S9) or metabolic system mix (+S9) were mixed and tempered at about 37°C.
The suspension was mixed with top agar and poured over minimal agar medium plate. The to agar was allowed to solidify at room temperature before final incubation.
Plates were incubated at about 37°C for about 72 hours.
Two controls were included in the experiment:
- negative control: absolute negative control
- positives control: control mutagens were used for each strain and experimental conditions - Rationale for test conditions:
- Confirmation test:
An independant confirmation test was performed with the test item. After the bacterial suspension, the test item and PSB (-S9) or metabolic activation system mix (+S9) were mixed and the mixture was incubated at about 37°C for about 20 minutes. Thereafter, the study was performed in the same was as the first test (described behind) - Evaluation criteria:
- The number of colonies per plate was counted with an automatic colony counter. Data are presented in tables as the number of colonies present per plate (mean +/- standard deviation). The ratio R is calculated as follows: R = number of revertant colonies in the presence of the test item / Number of revertant colonies in the absence of the test item.
Several criteria are used for determining a positive result: a dose-response in the range tested and/or areproductible increase at one or more concentrations in the number of revertant colonies per plates in at least one strain with or without metabolic activation system.
Positive results from the bacterial reverse mutation test indicate taht a test induces point mutations or frame-shifts in the genome of the tested experimental system.
Historical negative (solvent/vehicle) and positive control values are represented in the final report. this table include rationR, maxima, mean values and standard deviations. The historical control values have at least an n of 50. The values are updated on regular intervals with data obtained throughout the performance of studies.
Results and discussion
Test results
- Key result
- 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:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The following conclusions can be inferred from the obtained results:
- no experiment with the test item showed rations (R) above 2.5 as compared to the negative control,either with or without S9 metabolic activation
- no dose response was observed in none of the tested bacterial strains.
Based on the results obtained in this study, the test item was found NON MUTAGENIC and NON PRO-MUTAGENIC under the test conditions.
Applicant's summary and conclusion
- Conclusions:
- The following conclusions can be inferred from the obtained results:
no experiment with the test item showed rations (R) above 2.5 as compared to the negative control,either with or without S9 metabolic activation
- no dose response was observed in none of the tested bacterial strains.
Based on the results obtained in this study, the test item was found NON MUTAGENIC and NON PRO-MUTAGENIC under the test conditions. - Executive summary:
The present bacterial reverse mutation test (AMES test) was performed in order to evaluate the mutagenic potential of the test item.The test was performed in accordance with OECD Guideline 471 for the Testing of Chemical (Bacterial Reverse Mutation Test, Adopted 21st, July 1997) and the Test Method B13/B14 Of Commission Directive 2000/32/EC.
Doses ranging from 5μl to 0.05μl per plate were tested. No cytotoxicity was observed at any dose.
Suspension of 5 amino-acid requiring strains of Salmonella typhimurim (TA98, TA100, TA102, TA1535, TA 1537) auxotroph for an amino acid, were exposed to the test item in the presence and in the absence of an exogenous metabolic activation system.
After incubation, revertant colonies due to point mutations were counted and compared to the number of spontaneous revertant colonies on solvant control plate (negative control). similarly, specific standard mutagens were tested and used as positive controls.
Based on the results obtained in this study, the test item was found NON MUTAGENIC and NON PROMUTAGENIC under the test conditions.
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