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EC number: 201-741-4 | CAS number: 87-39-8
- 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
Violuric acid was tested in the reverse mutation assay (Ames Test) using four Salmonella Typhimurium strains (TA1535, TA1537, TA98, TA100) and one Escherichia Coli strain (WP2uvrA). The test was performed in accordance with OECD test guideline 471 using the plate incorporation and pre-incubation methods at five dose levels, both with and without the addition of rat liver homogenate metabolising system (S9 in standard co-factors). The dose range was determined from the result of a preliminary toxicity and cytotoxicity assay. The selected dose range was 0.05, 0.16, 0.50, 1.6 and 5 mg/plate and DMSO was used as solvent.
No toxicological significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose of violuric acid, either with or without metabolic activation, hence violuric acid was found to be non-mutagenic. Positive and negative controls included in the study was found to be in accordance to historical control data thus validating the study.
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:
- 29 September 2016 to 25 November 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Following GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- CAS: 87-39-8
Purity: ≥ 98%
Manufacturing date: 01/07/2016
Expiry date: 2 years
Lot no: 201616909T - Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 homogenate
- Test concentrations with justification for top dose:
- Based on the initial cytotoxicity test the concentrations of 0.05, 0.16, 0.5, 1.6 and 5 mg/plate were selected
- Vehicle / solvent:
- Dimethyl sulphoxide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Remarks:
- 2-aminoanthracene for trials with metabolic activation, the remaining controls are for trial without metabolic activation
- Details on test system and experimental conditions:
- Plates were incubated for 72 hours at 37 degrees Celsius
- Statistics:
- Not performed.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- 2.2-19.5 fold incease in numbers of revertant/plate
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- 2.2-19.5 fold incease in numbers of revertant/plate
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- 2.2-19.5 fold incease in numbers of revertant/plate
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- 2.2-19.5 fold incease in numbers of revertant/plate
- 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
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- 2.2-19.5 fold incease in numbers of revertant/plate
- Additional information on results:
- From the experimental results obtained, the mean numbers of revertant colonies at the tested concentrations were comparable to those of the vehicle control, in both trials, in the presence and absence of metabolic activation. There was no appreciable increase in the number of revertant colonies at any of the tested concentrations in both the trials. The number of revertant colonies in the positive controls resulted in 2.2 to 19.5 fold increase under identical conditions
- Conclusions:
- Based on the results obtained in this study, it was concluded that Violuric acid is non-mutagenic in the bacterial reverse mutation test, when tested up to 5 mg/plate in accordance to OECD 471.
- Executive summary:
Violuric acid was tested in the reverse mutation assay (Ames Test) using Salmonella Typhimurium strains (TA1535, TA1537, TA98, TA100) and Escherichia Coli strain (WP2uvrA). The test was performed in accordance with OECD test guideline 471 using the plate incorporation and pre-incubation methods at five dose levels, both with and without the addition of rat liver homogenate metabolising system (S9 in standard co-factors). The dose range was determined from the result of a preliminary toxicity and cytotoxicity assay. The selected dose range was 0.05, 0.16, 0.50, 1.6 and 5 mg/plate.
No toxicological significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose of violuric acid, either with or without metabolic activation per exposure method, hence violuric acid was found to be non-mutagenic. Positive and negative controls included in the study was found to be in accordance to historical control data thus validating the study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on available data violuric is non-mutagenic and no classification as mutagenic is needed.
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