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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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- 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:
- Do Non-Steroidal Anti-Inflammatory Drugs Induce Sister Chromatid Exchanges in T Lymphocytes?
- Author:
- Ozkul, Y; Erenmemisoglu, A; Ekecik, A; Saatci, C; Ozdamar, S; Demirtas, H
- Year:
- 1 996
- Bibliographic source:
- The Journal of International Medical Research 1996; 24: 84-87
Materials and methods
- Type of study / information:
- Sister Chromatid Assay
- Endpoint addressed:
- genetic toxicity
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In total, 8 humans were treated with 800 mg ibuprofen per day for a period of two weeks. Before and after treatment blood samples were taken, of which mean numbers of chromatid exchanges in the lymphocytes were counted.
- GLP compliance:
- no
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:
- Brufen®, is the registered trade name of Atabay Pharmaceuticals Inc.
Method
- Ethical approval:
- not specified
- Details on study design:
- Test subjects: 27 women and 21 men (17 - 24 years), with diagnoses of soft-tissue injury. All patients were healthy non-smokers and non-drug users. Each patient was interviewed aboul smoking habits, use of other drugs, details of work (exposure to physical or chemical agents), past illnesses, dietary habits, hereditary diseases, consumption of alcohol and coffee and other lifestyle factors that might influence the results. The patients had received no treatment for their injuries before entering this study. Written permission was obtained from each subject.
Heparinized blood samples (5 mL) were collected for peripheral lymphocyte culture before the start of treatment and after 2 weeks' treatment. Chromosome harvesting, treatment with hypotonic solution, fixation and staining were carried out according to standard methods, as previously described. The slides were finally stained with 3% Giemsa solution for 20 min. Twenty metaphase cells per patient were analysed, under a blind protocol, for the presence of sister chromatid exchanges.
The mean numbers of sister chromatid exchanges in human lymphocytes before and after treatment were compared using Student's t-test for paired observations. - Exposure assessment:
- measured
- Details on exposure:
- TYPE OF EXPOSURE: oral
TYPE OF EXPOSURE MEASUREMENT: blood samples
EXPOSURE LEVEL: 800 mg/day
EXPOSURE PERIOD: 2 weeks
EXPOSURE GROUPS: the group contained 8 patients
Results and discussion
- Results:
- There were no significant differences in the average numbers of sister chromatid exchanges in the peripheral lymphocytes of patients before and after treatment. There were no significant differences in the average numbers of sister chromatid exchanges between treated and untreated male and female patients. Analysis of the data for age in relation to sister chromatid exchanges revealed no change in the rate.
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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