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EC number: 202-075-7 | CAS number: 91-53-2
- 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
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- Water solubility
- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
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- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- 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
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
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- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Peer-reviewed assessment report (attached in section 13)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- not applicable
- GLP compliance:
- yes
- Remarks:
- self-certified to US EPA regulations [40 CFR Part 160]; and OECD regulations [ENV/MC/CHEM (98) 17]
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethoxyquin
- EC Number:
- 202-075-7
- EC Name:
- Ethoxyquin
- Cas Number:
- 91-53-2
- Molecular formula:
- C14H19NO
- IUPAC Name:
- ethoxyquin
- Details on test material:
- Chemical name
IUPAC: 6-ethoxy-2,2,4-trimethyl-1,2-dihydroquinoline
CAS: 6-ethoxy-1,2-dihydro-2,2,4-trimethylquinoline
Constituent 1
Method
- Target gene:
- histidine locus (Salmonella strains)
tryptophan locus (Escherichia coli tester strain WP2uvrA)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix that was obtained from Aroclor-induced rat livers.
- Test concentrations with justification for top dose:
- 10.0, 33.3, 100, 333, 1,000, 2,000, and 5,000 µg/plate (±S9, Salmonella strains)
33.3, 100, 333, 1,000, 3,330 and 5,000 µg/plate (±S9, Escherichia coli tester strain WP2uvrA) - Vehicle / solvent:
- - Vehicle/solvent used.
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- The doses tested in the mutagenicity assay were selected based on the results of a dose range finding study using tester strains TA100 and WP2uvrA and ten doses of test article ranging from 6.67 to 5,000 µg/plate one plate per dose, both in the presence and absence of S9 mix that was obtained from Aroclor-induced rat livers.
The tester strains used in the mutagenicity assay were Salmonella typhimurium test strains TA98, TA100, TA1535, and TA1537 and Escherichia coli tester strain WP2uvrA. The assay was conducted in both the presence and absence of S9 mix along with concurrent vehicle and positive controls using three plates per dose. The doses tested in the mutagenicity assay with all Salmonella tester strains in both the presence and absence of S9 mix were 10.0, 33.3, 100, 333, 1,000, 2,000, and 5,000 µg/plate. The doses tested in the mutagenicity assay with tester strain WP2uvrA in both the presence and absence of S9 mix were 33.3, 100, 333, 1,000, 3,330 and 5,000 µg/plate. The results of the initial mutagenicity assay were confirmed in an independent experiment.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Positive controls validity:
- valid
Any other information on results incl. tables
The test article did not cause an increase in the mean number of revertants per plate with any of the tester strains either in the presence or absence of microsomal enzymes (S9). The positive control substances gave the expected increase in mutant frequencies.
Applicant's summary and conclusion
- Conclusions:
- As information was provided via a peer-reviewed assessment report, it can be considered as sufficiently reliable to assess the potential of ethoxyquin for the induction of gene mutations in bacteria. Under the conditions of this study, ethoxyquin proved negative in a reverse mutation assay (Ames test) in different tester strains of Salmonella typhimurium and Escherichia coli.
- Executive summary:
In a reverse gene mutation assay in bacteria (OECD 471), Salmonella typhimuriumtest strains TA98, TA100, TA1535, and TA1537 and Escherichia coli tester strain WP2uvrA were exposed to ethoxyquin at concentrations of 10.0, 33.3, 100, 333, 1,000, 2,000, and 5,000 µg/plate resp. 33.3, 100, 333, 1,000, 3,330 and 5,000 µg/plate in the presence and absence of mammalian metabolic activation (Aroclor-induced rat liver S9).
Ethoxyquin was tested up to the limit concentration 5000 µg/plate. The positive controls induced the appropriate responses in the corresponding strains.There was no evidence or a concentration related positive response of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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