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EC number: 241-753-7 | CAS number: 17772-51-9
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one is not mutagenic or clastogenic in guideline in vitro studies; i.e. bacterial reverse mutation study, in vitro micronucleus test and mammalian gene mutation assay.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- other: Chinese hamster lung fibroblasts (V79): the cells have a stable karyotype with a modal chromosome number of 22
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-naphthoflavone induced rat liver S9-mix
- Test concentrations with justification for top dose:
- Pretest on toxicity
4 h in the presence and 4 and 24 h in the absence of a metabolic activation system:
10.2 µg - 1300 µg/ml
The highest concentration was based on the solubility properties of the test item
GENE MUTATION ASSAY
--EXPERIMENT I
4 h without S9 mix:
1.8, 5.4, 16,0 (P), 48.1 (P), 144.3 (P), 433.0(P) µg/ml
4 h with S9 mix:
1.8, 5.4, 16,0 (P), 48.1 (P), 144.3 (P), 433.0(P) µg/ml
--EXPERIMENT II
24 h without S9 mix:
1.8, 5.4, 16,0, 48.1 (P), 144.3 (P), 433.0(P) µg/ml
4 h with S9 mix:
1.8, 5.4, 16,0 (P), 48.1 (P), 144.3 (P), 433.0 (P) µg/ml
P = Precipitation at the end of treatment visible to the unaided eye - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- The assay was performed in 2 independent experiments, using 2 parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation
- Evaluation criteria:
- A test item is classified as positive if it induces either a concentration-related increase of the mutant frequency or a reproducible and positive response at one of the test points that is three times above the spontaneous mutation frequency.
A test item producing neither a concentration-related increase of the mutant frequency nor a reproducible positive response at any of the test points is considered non-mutagenic in this system. - Statistics:
- A linear regression (least squares) was performed to assess a possible dose dependent increase of mutant frequencies. The number of mutant colonies obtained for the groups treated with the test item were compared to the solvent control groups. A trend is judged as significant whenever the p-value (probability value) is below 0.05.
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- the positive controls were functional
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
The study was performed to investigate the potential of Macrolex Gelb G to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster according to OECD TG 476 under GLP conditiions. The assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation. The used concentrations ranged between 1.8 and 433.0 µg/ml.Precipitation occurred at 16.0 µg/ml and above in experiment I with and without metabolic activation and in experiment II with metabolic activation. In experiment II without metabolic activation precipitation was observed at 48.1 µg/ml. No relevant cytotoxic effects indicated by a relative cloning efficientcy 1 or cell density below 50% was observed in experiment I and II after 4 and 24 hours treatment with and without metabolic activation..
No relevant and reproducible dose dependent increase in mutamt colony numbers/10 (exp 6) was observed in both main experiments. Appropriate reference mutagens, used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system.
In conclusion, it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, Macrolex Gelb G is considered to be non-mutagenic in this HPRT assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Additional information from genetic toxicity in vitro:
3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one was examined for point mutations in bacteria using the Ames test according to OECD TG 471 under GLP conditions. 5 strains (S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102) and concentrations up to 5000 µg/plate in the presence and absence of a metabolic activation system were investigated. 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one is considered negative in this test.
An in vitro mammalian gene mutation assay was performed to investigate the potential of 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster according to OECD TG 476 under GLP conditions. No relevant and reproducible dose dependent effect was reported.
A micronucleus test was conducted according to OECD TG 487 to investigate the potential to induce micronuclei in human lymphocytes in vitro. In two independent experiments 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one did not induce micronuclei in this test.
Justification for selection of genetic toxicity endpoint
3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one is not mutagenic
or clastogenic in guideline in vitro studies; i.e. bacterial reverse
mutation study, in vitro micronucleus test and mammalian gene mutation
assay.
Justification for classification or non-classification
3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one is not mutagenic or clastogenic in guideline in vitro studies; i.e. bacterial reverse mutation study, in vitro micronucleus test and mammalian gene mutation assay.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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