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EC number: 239-784-6 | CAS number: 15687-27-1
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative mutagenic and genotoxic effects of three propionic acid derivatives ibuprofen, ketoprofen and naproxen
- Author:
- Philipose, B; Sing, R; Khan, KA; Giri, AK;
- Year:
- 1 997
- Bibliographic source:
- Mutation Research 393 (1997) 123-131
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A sister chromatid exchange (SCE) assay was performed in Swiss mice. Paraffin-coated BrdU tablets were implanted subcutaneous, and the test substance was administered once intraperitoneal (25, 50, 100 mg/kg, 1h after tablet implantation) or once orally (gavage, 270 mg/kg, 0.5 h after tablet implantation) in 5 male mice per dose. Twenty-four hours after implantation, bone marrow slides were prepared and stained with fluorescence-plus-Giemsa technique. Per dose 150 cells were counted.
- GLP compliance:
- no
- Type of assay:
- sister chromatid exchange assay
Test material
- Reference substance name:
- Ibuprofen
- EC Number:
- 239-784-6
- EC Name:
- Ibuprofen
- Cas Number:
- 15687-27-1
- Molecular formula:
- C13H18O2
- IUPAC Name:
- 2-(4-isobutylphenyl)propanoic acid
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Ibuprofen, purchased from the Sigma Chemical Company (St. Louis, MO).
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Division of Laboratory Animals, Central Drug Research Institute, Lucknow.
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 30g
- Housing: 5 per cage with husk bedding
- Diet: standard rodent pellet diet (Gold Mohar, Lipton India Ltd., Chandigarh, India), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 28 ± 2
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- other: intraperitoneal and oral (gavage)
- Vehicle:
- VEHICLES
- Intraperitoneal: DMSO
- Oral: distilled water in 2% gum acacia - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
- Intraperitoneal: injection of 75 µL/mouse
- Oral: 0.3 mL/mouse - Duration of treatment / exposure:
- 24 hours
- Frequency of treatment:
- Single administration
Doses / concentrationsopen allclose all
- Dose / conc.:
- 25 mg/kg bw/day
- Remarks:
- intraperitoneal
- Dose / conc.:
- 50 mg/kg bw/day
- Remarks:
- intraperitoneal
- Dose / conc.:
- 100 mg/kg bw/day
- Remarks:
- intraperitoneal
- Dose / conc.:
- 270 mg/kg bw/day
- Remarks:
- oral
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Intraperitoneal: Mitomycin C, 1.5 mg/kg bw
- Oral: Cyclophosphamide in distlled water, 10 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The dose selected for the in vivo studies of three drugs (ibuprofen, naproxen, ketoprofen) was based on the LD50 dose of ibuprofen available in the literature. The highest dose selected in the i.p. study (100 mg/kg) was approximately one-third of the LD50 (320 mg/kg) of mice for ibuprofen reported earlier.
TREATMENT AND SAMPLING TIMES: BrdU tablets were implanted subcutaneously in the flank of mice under ether anesthesia. The substance was administered intraperitoneal (1h after implantation) and oral (0.5 hour after implantation).
DETAILS OF SLIDE PREPARATION:
- I.P. For SCE analysis, colchicine 4 mg/kg was injected i.p. 22 h after Brdu tablet implantation. Two hours later bone marrow was expelled with 0.075 M KCl at 37 °C for 20 min, cells were fixed three times with methanol/acetic acid (3:1). The slides were prepared and chromosomes were differentially stained with fluorescence-plus-Giemsa technique.
- ORAL: Twenty-two hours after the BrdU tablet implantation, colchicine was injected, and the rest of the procedure was the same as described above.
METHOD OF ANALYSIS: All the slides were coded and 30 second-division metaphase cells (40 ± 2 chromosomes) per animal were scored for SCE frequencies, i.e. a total of 150 cells were scored per dose tested. - Statistics:
- - Dunnett’s multiple comparison for i.p. SCE results
- Student's t-test to compare the oral SCR results of each treated group
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- positive
- Remarks:
- at 50- and 100- mg/kg doses (intraperitoneal) and at 270 mg/kg (oral)
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- A significant increase in SCE was observed at 50- and 100-mg/kg doses. A single oral dose of ibuprofen (270 mg/kg) also gave a weak, but significant, increase in SCE when compared with control.
The SCE/cell after i.p. administration was 4.50, 5.04, 5.70, and 6.00 at 0, 25, 50, and 100 mg/kg bw.
The SCE/cell after oral administration was 4.68 and 6.16 at 0 and 270 mg/kg bw.
Applicant's summary and conclusion
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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