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EC number: 947-951-6 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Genetic toxicity in vitro (OECD TG 471, Ames): Not mutagenic
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:
- 01 Feb 2018 - 28 Mar 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 8 May 2017
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Trinova Biochem
- Suitability of cells: according to Dr. Bruce N. AMES
- Methods for maintenance in cell culture if applicable: Test strains were kept as lyophilisate pellets at 4°C. The lyophilisates of the test strains were used to inoculate the overnight cultures. Overnight cultures were grown in a water bath for 15 h at 37°C in Oxoid 2 nutrient broth.
- The final cell density was approximately 10^8 - 10^9 cells/mL.
MEDIA USED
- Type and identity of media: Oxoid 2 nutrient broth
- Properly maintained: Yes, regularly checked for genetic identity of the strains, their sensitivity to UV-radiation and crystal violet and their resistance to ampicillin and tetracycline. - Additional strain / cell type characteristics:
- other: All: permeability to macromolecules TA98,100,1535,1537: no DNA excision repair TA98,100,102: R-factor plasmid TA102: plasmid, carrier of tetracycline resistance TA98,100,102: resistance to Ampicillin TA1535, TA1537: non-resistance to Ampicillin
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Preliminary cytotoxicity test: 10 to 100 000 µg/plate and 0.2 mL undiluted test item/plate
Signs of cytotoxicity were observed from 1000µg/plate (scarce background lawn), ad was therefore chosen as top dose in the main experiment.
Main study: 3.16, 10, 31.6, 100, 316 and 1000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethanol
- Justification for choice of solvent/vehicle: well-known and compatible vehicle - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) or preincubation
- Cell density at seeding (if applicable): density was approximately 10^8 - 10^9 cells/mL.
DURATION
- Preincubation period: 20 min at 37°C
- Exposure duration: 48 h
DETERMINATION OF CYTOTOXICITY
- Method: scarce background lawn and/or reduction of the number of revertants by more than 50% - Rationale for test conditions:
- According to OECD TG 471
- Evaluation criteria:
- The results of the negative and positive control cultures should be within the range of the historical data
The range of spontaneous reversion frequencies per plate is based on Kirkland (1990):
TA98: 20 - 60
TA100: 100 - 200
TA102: 240 - 320
TA1535: 10 - 35
TA1537: 3 - 20
Where concurrent negative or positive control data fall outside the range, they may be acceptable and considered for the inclusion into the historical control distribution as long as these data are not extreme outliers.
A test item is considered to show a positive response if
- the number of revertants is significantly increased compared to the solvent control to at least 2-fold of the solvent control for TA98, TA100, TA1535 and TA1537 and 1.5-fold of the solvent control for TA102 in both independent experiments.
- a concentration-related increase over the range tested in the number of the revertants per plate is observed.
- biological relevance of the results should be considered first.
Positive results from the bacterial reverse mutation test indicate that a substance induces point mutations by base substitutions or frameshifts in the genome of Salmonella typhimurium.
A test item for which the results do not meet the above mentioned criteria is considered as non-mutagenic in the AMES test. - Statistics:
- U-test according to MANN and WHITNEY and Spearman's rank correlation coefficient where applicable.
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Ten concentrations ranging from 10 µg Ginger CO2-se extract to 0.2 mL undiluted test item/per plate were tested. Pronounced to complete cytotoxicity (scarce background lawn and/or reduction of the number of revertants by more than 50%) was noted starting at a concentration of 1000 μg Ginger CO2-se extract/plate in both experiments.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data:
TA98
-S9: 158.8 (sd 26.2) min102 - max293
+S9: 157.6 (sd 26.9) min104 - max291
TA100
-S9: 954 (sd 102.1) min701 - max1365
+S9: 949.5 (sd 104.3) min703 - max1238
TA102
-S9: 1020.7 (sd 90.8) min756 - max1263
+S9: 1015.0 (sd 95.1) min759 - max1311
TA1535
-S9: 144.5 (sd 44.7) min62 - max406
+S9:144.5 (sd 47.4) min67 - max404
TA1537
-S9:75.0 (sd 26.9) min28 - max185
+S9:75.9 (sd 26.4) min31 - max184
- Negative (solvent/vehicle) historical control data:
TA98
-S9: 30.2 (sd 5.6) min20 - max49
+S9: 31.9 (sd 5.9) min20 - max49
TA100
-S9: 145.9 (sd 19.6) min95 - max200
+S9: 145.1 (sd 19.9) min100 - max209
TA102
-S9: 278.1 (sd 16.9) min245 - max323
+S9: 279.0 (sd 17.5) min203 - max324
TA1535
-S9: 19.7 (sd 4.4) min10 - max34
+S9:19.9 (sd 4.6) min10 - max36
TA1537
-S9: 6.7 (sd 1.8) min2 - max10
+S9:6.7 (sd 1.8) min2 - max10
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: [complete, e.g. CBPI or RI in the case of the cytokinesis-block method; RICC, RPD or PI when cytokinesis block is not used]
- Other observations when applicable: [complete, e.g. confluency, apoptosis, necrosis, metaphase counting, frequency of binucleated cells] - Conclusions:
- Based on the results of the in vitro gene mutation study in bacteria for Ginger CO2-SE extract, the test substance does not need to be classified for mutagenicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
The potential of Ginger CO2 -SE extract to induce gene mutations was examined in a OECD TG 471 study, under GLP. Ginger CO2 -SE extract was examined in 5 Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in two independent experiments, without and with metabolic activation. The first experiment was carried out as a plate incorporation test and the second as a preincubation test. Ginger CO2 -SE extract was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA100. Ten concentrations ranging from 10 to 100 000 µg Ginger CO2 -SE extract/plate in ethanol and 0.2 mL undiluted test item/plate were tested. Due to pronounced cytotoxicity at the concentration of 3160 µg Ginger CO2 -SE extract/plate, and cytotoxicity at the concentration of 1000 µg/plate, 1000 µg Ginger CO2 -SE extract per plate were chosen as top concentration for the main study.
Main study: Six concentrations ranging from 3.16 to 1000 µg Ginger CO2 -SE extract/plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation. Cytotoxicity (reduction of the number of revertants by more than 50% and/or scarce background lawn) was noted in all experiments without and with metabolic activation at the top concentration of 1000 µg Ginger CO2-se extract/plate in all test strains. No increase in revertant colony numbers as compared with control counts was observed for Ginger CO2 -SE extract under any condition.
The positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.
Under the present test conditions, Ginger CO2 -SE extract tested up to a concentration of 1000 µg/plate that led to cytotoxicity, caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The potential of Ginger CO2-se extract to induce gene mutations was examined in a OECD TG 471 study, under GLP. Ginger CO2 -SE extract was examined in 5 Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in two independent experiments, without and with metabolic activation. The first experiment was carried out as a plate incorporation test and the second as a preincubation test. Ginger CO2 -SE extract was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA100. Ten concentrations ranging from 10 to 100 000 µg Ginger CO2 -SE extract/plate in ethanol and 0.2 mL undiluted test item/plate were tested. Due to pronounced cytotoxicity at the concentration of 3160 µg Ginger CO2 -SE extract/plate, and cytotoxicity at the concentration of 1000 µg/plate, 1000 µg Ginger CO2 -SE extract per plate were chosen as top concentration for the main study.
Main study: Six concentrations ranging from 3.16 to 1000 µg Ginger CO2 -SE extract/plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation. Cytotoxicity (reduction of the number of revertants by more than 50% and/or scarce background lawn) was noted in all experiments without and with metabolic activation at the top concentration of 1000 µg Ginger CO2 -SE extract/plate in all test strains. No increase in revertant colony numbers as compared with control counts was observed for Ginger CO2-se extract under any condition.
The positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.
Under the present test conditions, Ginger CO2 -SE extract tested up to a concentration of 1000 µg/plate that led to cytotoxicity, caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
Justification for classification or non-classification
Based on the results of the in vitro gene mutation study in bacteria for Ginger CO2 -SE extract, the test substance does not need to be classified for mutagenicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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