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EC number: 616-968-8 | CAS number: 8015-92-7
- 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
Anthemis nobilis, ext., (Chamomile oil) was tested in a guideline (OECD 471)- and GLP-compliant bacterial reverse mutation assay. The substance was tested at up to 5 mg/plate using a plate incorporation method, with Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli strain WP2uvrA (pKM101), with and without a rat liver -derived metabolic activation fraction. The test material was not mutagenic under the conditions of this assay (Mee, 2017).
No mammalian cell in vitro genotoxicity data were identified, or are needed.
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:
- 19 Jan 2017 - 27 Mar 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)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Berjé Incorporated, 700 Blair Road, Carteret NJ 07008, USA.
- Lot/batch No.of test material: R-92286
- Expiration date of the lot/batch: 14 September 2018.
- Purity test date: 14 September 2016.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (cool, away from heat and sources of ignition) - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- E. coli WP2uvrA (pKM101)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254/rat liver-derived (S9)
- Test concentrations with justification for top dose:
- Test 1: 0, 1.6, 5, 16, 50, 160, 500, 1600 and 5000 ug/plate
Test 2: 0, 5, 16, 50, 160, 500, 1600 and 5000 ug/plate.
Highest tested concentration is guideline limit dose. - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-Aminoanthracene; potassium dichromate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Incubation period: 3 days
NUMBER OF REPLICATIONS: All tests (solvent controls, test item and positive controls) were carried out in triplicate
- OTHER: The number of revertant colonies was scored using a Sorcerer Colony Counter, except in cases where the mean incidence of revertant colonies on the solvent control plates was 20 or less (typically with strains TA1535 and TA1537). - Evaluation criteria:
- A test item was considered to be mutagenic if the following criteria were satisfied:
1. For TA1535 or TA1537, the mean number of revertant colonies of one or more doses of the test item, with or without metabolic activation was equal to or greater than 2 times the concurrent solvent control mean value and the relevant historical mean value; for any other strain, the mean number of revertant colonies was equal to or greater than 2 times the concurrent solvent control mean value in the presence of one or more doses of the test item, with or without metabolic activation.
2. There was a dose-related increase in the number of revertant colonies.
3. Any increase was reproducible. - 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 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 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:
- E. coli WP2 uvr A pKM 101
- 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
- Remarks on result:
- other: Mutagenicity Test 1
- Conclusions:
- Anthemis nobilis, ext., (Chamomile oil) was not mutagenic in an OECD guideline- and GLP-compliant bacterial reverse mutation assay using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli strain WP2uvrA (pKM101) when tested at up to cytotoxic and precipitating concentrations, with and without metabolic activation.
- Executive summary:
Anthemis nobilis, ext., (Chamomile oil) was tested in a guideline (OECD 471)- and GLP-compliant bacterial reverse mutation assay. The substance was tested at up to 5 mg/plate using a plate incorporation method, with Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli strain WP2uvrA (pKM101), with and without a rat liver -derived metabolic activation fraction. The test material was not mutagenic under the conditions of this assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
No in vivo genotoxicity data were identified, or are needed.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the results of the available and reliable in vitro bacterial reverse mutation assay (Mee, 2017), Anthemis nobilis ext., does not warrant classification for genotoxicity, according to EU CLP criteria (EC 1272/2008).
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