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Diss Factsheets
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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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one
- EC Number:
- 241-753-7
- EC Name:
- 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one
- Cas Number:
- 17772-51-9
- Molecular formula:
- C18H11NO3
- IUPAC Name:
- 3-hydroxy-2-(3-hydroxyquinolin-2-yl)-1H-inden-1-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: Macrolex Gelb G
Physical State/Appearance: Solid / yellow powder
Purity/Concentration as Supplied: 99.1 (weight %)
Purity/Concentration for Formulation: 100%
Correction for Purity: No
Stability of Test Item in Vehicle: Assessed
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once per day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300 and 1000 mg/kg body weight/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 per sex and dose and group
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Based on the results of this study, the no-observed-effect-level (NOEL) and no-observed-adverse-effect-level (NOAEL) were considered to be 1000 mg/kg body weight/day of 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one, the highest dose tested.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Mortality / Viability
All animals survived the scheduled treatment or recovery periods.
Clinical Signs (Daily and Weekly)
Orange discoloration of the feces, a common finding in oral studies performed with dyestuffs or colored test items, was noted at all dose levels and considered to be of no toxicological relevance.
Functional Observational Battery / Grip Strength / Locomotor Activity
There were no findings recorded during the functional observational battery at 4 weeks, including grip strength and locomotor activity.
Food Consumption / Body Weights
The mean absolute and relative food consumption of the test item-treated rats were unaffected and the mean absolute body weights and body weight gain of all treated groups compared favorably with those of the controls.
Hematology
There were no test item-related differences in the hematology parameters of males and females at any dose level.
Clinical Biochemistry
The clinical biochemistry parameters of rats at all dose levels were unaffected by treatment with the test item.
Urinalysis
The urinalysis parameters of the test item-treated animals compared favorably with those of the controls.
Organ Weights
Mildly elevated liver weights were noted at all dose levels and considered to be non-adverse, adaptive metabolic changes.
Macroscopic / Microscopic Findings
There were no treatment related macroscopic or microscopic findings.
Overall, although the slight increase in the incidence of dark yellow urine implies that a minimal absorption cannot be excluded, no discoloration was noted in any organ and there were no correlating macroscopical or microscopical findings. The treated groups showed only minimally elevated mean relative liver weights but these differences were dose-unrelated, without concomitant changes in liver-specific biochemistry parameters and without any correlating pathomorphological findings, and were considered to be unrelated to the treatment with the test item.
Based on the results of this study, the no-observed-effect-level (NOEL) and no-observed-adverse-effect-level (NOAEL) were considered to be 1000 mg/kg body weight/day of 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one, the highest dose tested.
Applicant's summary and conclusion
- Executive summary:
Oral administration of 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one to Wistar rats at doses of 100, 300 and 1000 mg/kg/day for 28 days resulted in no changes of toxicological relevance. The orange discoloration of the feces noted in all treated groups represents a typical finding in gavage studies with colored substances or dyestuffs.
Although the slight increase in the incidence of dark yellow urine implies that a minimal absorption cannot be excluded, no discoloration was noted in any organ and there were no correlating macroscopical or microscopical findings. The treated groups showed only minimally elevated mean relative liver weights but these differences were dose-unrelated, without concomitant changes in liver-specific biochemistry parameters and without any correlating pathomorphological findings, and were considered to be unrelated to the treatment with the test item.
Based on the results of this study, the no-observed-effect-level (NOEL) and no-observed-adverse-effect-level (NOAEL) were considered to be 1000 mg/kg body weight/day of 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one, the highest dose tested.
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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