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EC number: 294-955-2 | CAS number: 91771-62-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cyperus scariosus, Cyperaceae.
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test (similair to OECD 471): non-mutagenic with or without metabolic activation
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 03 2012- May 06 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- The Ames microplate assays are modified fluctuation tests using 384-well plates (48 wells per sample, per dose).
The modified microplate test, Ames MPF PENTA I, in brief is as follows:
1. Pre-growth of tester strains overnight in Oxoid broth.
2. A 90 minute incubation in Exposure Medium with limiting histidine/tryptophan in the presence of test sample and S9 if employed.
3. Distribution and plating of cells in a medium which selects for revertants. This medium is free of histidine/tryptophan and contains a pH indicator dye that turns
from purple to yellow upon colony growth.
4. Incubation of the microtiter plates for 48 hours at 37C to allow growth of revertant colonies.
5. Scoring of microtiter plates for positive (yellow) wells, data entry, and evaluation of mutational potential. - GLP compliance:
- no
- Remarks:
- The assays reported in this document were performed according to Xenometrix’ Quality Assurance SOP’s.
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- Absense of S9: 50, 15.8, 5, 1.58, 0.5, 0.158 ppm. Cytotoxicity is used for justification for top dose.
Presense of S9: 2000, 633, 200, 63.3, 20, 6.3 ppm
- Vehicle / solvent:
- ethanol
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- other: 2-nitrofluorone, N-aminocytidine, 2-aminoantracene
- Evaluation criteria:
- The following criteria were used to evaluate the results: fold increase over the solvent control baseline, dose-dependency and the Student’s t-test. The fold increase of revertants relative to the solvent control was determined by dividing the mean number of positive wells at each dose by that of the solvent control baseline. The solvent control baseline was derived from the mean number of positive wells in the solvent control plus 1 standard deviation. If the baseline was below 1, it was set to 1. There were 3 solvent control replicates for each test condition (e.g. TA98 without S9, TA98 with S9 etc.). A fold increase equal to or greater than 2 times the baseline level (red-dotted line in graphs below) is rated as possibly positive in the assay. Multiple responses of greater than 2-fold the baseline level with a doseresponse will lead to the test compound being classified as a clear positive. A test compound is classified negative where no response greater than 2 times the baseline is recorded. Student’s t-test (unpaired, one-sided) has been used to determine significance at the a = 0.05 level. Although statistical analysis has been applied to all data collected, increases in revertant yields are not classified as positive if less than 2.0-fold over the baseline value, and if no dose-response is observed.
- Statistics:
- Student's t-test
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- 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
- Conclusions:
- Cyperus scariosus, ext. showed no increases of greater than 2-fold the baseline in any strain and under any conditions at the non-cytotoxic concentraions. According to the Ames MPF PENTA I data, Cyperus scariosus, ext. is negative for mutational activity.
Reference
In the main assay with all strains, in the absence of S9, there was visible and statistically significant cytotoxicity of test item in TA100 and TA1537 at the highest concentration (50 ppm). With S9, no sign of cytotoxicity in strains TA98 and EC Combo was observed. Indications of cytotoxic effect between 200 and 2000 ppm were observed in the other strains: in TA100 and TA1535, the three highest doses resulted in zero positive wells and in TA1537 in a decrease of the positive wells as compared to the solvent control. However, no increase in the intensity of the color of the medium was observed at these concentrations.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The objective of the study was to determine the potential of Cyperus scariosus, ext. and/or its metabolites to induce reverse mutations at the histidine locus in several strains of Salmonella typhimurium (S. typhimurium; TA98, TA100, TA1535, and TA1537), and at the tryptophan locus of Escherichia coli (E. coli) strain WP2uvrA in the presence or absence of an exogenous mammalian metabolic activation system (S9). The method used was Ames MPF PENTA I assay.
For the pre-screen assay, the test item was tested up to concentrations of 40 000 ppm in the strain TA100. The concentrations chosen were all cytotoxic when tested in the absence of S9, whereas with S9, no clear toxic effect observable.
In the second assay, the test item was tested in absence of S9 up to concentrations of 50 ppm and in the presence of S9 up to concentrations of 2000 ppm.
There was no increase the number of revertants greater than two-fold the baseline in any strains and under any condition at the non-cytotoxic doses. According to the criteria to evaluated MPR PENTA I data, test sample Cyperus scariosus, ext. is negative at the concentrations tested.
Justification for classification or non-classification
Based on the results of in vitro bacterial gene mutation study, no classification is proposed for genotoxicity according to the criteria of CLP regulation 1272/2008.
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