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EC number: 282-025-9 | CAS number: 84082-79-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Salvia officinalis, Labiatae.
- 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: non mutagenic (OECD 471, GLP, K, rel. 1).
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:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine and tryptophan
- 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:
- S9 fraction, microsome fraction prepared from Sprague Dawley rat liver homogenate, is provided by MOLTOXTM
- Test concentrations with justification for top dose:
- Test for Mutagenicity (Experiment 1) – Plate Incorporation Method:
Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2uvrA (with and without S9 mix): 50, 150, 500, 1500 and 5000 μg/plate
Test for Mutagenicity (Experiment 2) – Pre-Incubation Method:
Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2uvrA (with S9 mix): 50, 150, 500, 1500 and 5000 μg/plate - Vehicle / solvent:
- paraffin oil.
The item is soluble. An extemporaneous stock solution for each assay was prepared at 50 mg/mL in paraffin oil (not soluble in water, NaCl 0.15M). - Negative solvent / vehicle controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- 9-aminoacridine
- sodium azide
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: cis-Platinum (II) Diammine Dichloride, 2-Nitrofluorene and 2-Anthramine
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM:
Strains of Salmonella typhimurium and Escherichia coli are purchased from MOLTOX
METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 37 °C for 30 minutes (with shaking)
- Exposure duration: Plates were incubated at 37 °C ± 3 °C for approximately 48-72 hours
NUMBER OF REPLICATIONS: Triplicate plates per dose level.
DETERMINATION OF CYTOTOXICITY
- Method: The plates were viewed microscopically for evidence of thinning (toxicity) - Rationale for test conditions:
- The maximum dose level of the test item in the first experiment was selected as the maximum recommended dose level of 5000 μg/plate.
- Evaluation criteria:
- Ensure that the criteria of validity of the study are well respected namely
There should be a mimimum of four non-toxic test item dose levels
the bacteriostatic activity of the highest concentration tested shall be equal to or less than 75 %.
The spontaneous reversion rate of the absolute negative control shall comply with the historical values of the laboratory,
the spontaneous reversion rate of the solvent shall not be statistically different from absolute negative control,
the mean number of revertant colonies obtained for each strain and the corresponding positive control, with and/or without metabolic activation shall comply with the historical values of the laboratory.
Negative and positive values should not show significant difference with the historical values of the laboratory (± 2 standard deviations). - Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- STERILITY CONTROLS:
absence of any bacterial growth in the presence of the various concentrations of the test item.
absence of any bacterial growth in the presence of "S9-mix".
BACTERIOSTATIC ACTIVITY CONTROL:
neither original solution nor dilutions on TA100 have bacteriostatic effect. The test item is tested at these doses (5 000, 1 500, 500, 150 and 50 μg/plate).
MUTATION ASSAY
All controls (positive and negative with and without metabolic activation) showed the expected response when compared with the corresponding historical values obtained in the laboratory .
In the presence of the test item stock solution and dilutions (5 000, 1 500, 500, 150 and 50 μg/plate) without and with metabolic activation (direct and indirect incorporation methods) we measure no increase in the number of revertant colonies at least two-fold that of spontaneous revertant colonies for TA 98, TA 100 and Escherichia coli WP2(uvrA-) (pKM 101), and three-fold for TA 1535 and TA 1537 in the presence of the test item stock solution and dilutions (5 000, 1 500, 500, 150 and 50 μg/plate).
The test item (code as) GQP021117 not show any excessive toxic effect and precipitate formation in any strain at all doses studied.
Results are confirmed in an independent experiment. - Conclusions:
- Under the test condition, test substance is not mutagenic with and without metabolic activation in S. typhimurium (strains TA1535, TA1537, TA98 and TA100) and E.coli WP2 uvrA.
- Executive summary:
Solutions obtained from the test item have been tested for their capacity to induce reverse mutation in four Salmonella typhimurium strains and one Escherichia coli WP2(uvr A¯)(pKM101) strain. This study was performed in the absence and presence of metabolic activation. Two independent assays (plate incorporation and pre-incubation methods) were carried out
For assay n° 1, plate incorporation method, various concentrations of the test item were put in contact with the strains in the absence and presence of a metabolic activation system (S9-mix 10% (v/v)).
For assay n° 2,pre-incubation method, various concentrations of the test item were put in contact with the strains in the absence of metabolic activation and with pre-incubation in the presence of metabolic activation system (S9-mix 10% (v/v)).
For both assays, negative and positive controls were carried out in parallel. Positive controls induced a significant increase in the number of revertant colonies compared to negative controls. There is no significant difference between the number of spontaneous reversions in negative and vehicle controls, the number of reversions obtained in the positive controls (without and with metabolic activation), and the mean of corresponding experimental “historical” values obtained in the laboratory. The vehicle control plates gave counts of revertant colonies within the normal and historical range.
These results validate the two tests.
There is no evidence of any increase in the number of revertant colonies in the presence of the various concentration of the test item (5 000, 1 500, 500, 150 and 50 μg/plate), without and with metabolic activation in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and in Escherichia coli WP2(uvrA¯) (pKM 101).The test item (code as) GQP021117 not show any excessive toxic effect and precipitate formation in any strain at all doses studied.
Doses (5 000, 1 500, 500, 150 and 50 μg/plate) performed from solutions of the test item , do not induce any mutagenic change in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and in Escherichia coli WP2(uvrA-) (pKM 101) without, or with metabolic activation, according to the OECD Guidelines n°471.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Summary of genotoxicity test
Test n° |
Test / Guideline Reliability |
Focus |
Strains tested |
Metabolic activation |
Test concentration |
Statement |
1
Savineau 2018 |
Ames Test (OECD 471) K, rel. 1 |
Gene mutation |
TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA |
-S9 +S9 |
Up to cytotoxic or highest recommended concentration |
-S9 : non mutagenic +S9 : non mutagenic |
Justification for classification or non-classification
Harmonized classification:
The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the available information, no classification is proposed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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