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EC number: 203-157-5 | CAS number: 103-90-2
- 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 germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the ability of paracetamol to produce chromosome aberrations in man
- Author:
- Ph. Hantson a,, L. de Saint-Georges b p. Mahieu a, E.D. Lonard c, M.C. Crutzen-Fayt c, A. L6onard c
- Year:
- 1 996
- Bibliographic source:
- Mutation Research 368 (1996) 293-300
Materials and methods
- Principles of method if other than guideline:
- Evaluation of the ability of paracetamol to produce chromosome aberrations in man
- GLP compliance:
- not specified
- Type of assay:
- mammalian germ cell cytogenetic assay
Test material
- Reference substance name:
- Acetaminophen
- IUPAC Name:
- Acetaminophen
- Reference substance name:
- Paracetamol
- EC Number:
- 203-157-5
- EC Name:
- Paracetamol
- Cas Number:
- 103-90-2
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- .
- Test material form:
- other: Solid
- Details on test material:
- - Name of test material (as cited in study report): Acetaminophen
- Molecular formula (if other than submission substance): C8-H9-N-O2
- Molecular weight (if other than submission substance): 151.1641
- Substance type: Organic
- Physical state: Solid
Constituent 1
Constituent 2
Test animals
- Species:
- other: Human
- Details on species / strain selection:
- Five male non-smoking healthy volunteers aged 25-35 were chosen among the staff of the Catholic University of Louvain. They had received no medication
nor any exposure to ionising radiation during the last 12 months. Blood was sampled before and 24, 72 and 168 h after ingestion of a single oral dose of 3 g paracetamol. The plasma level of paracetamol was below 2 /zg/ml, 24 h after ingestion. - Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Source:The staff of the Catholic University of Louvain.
- Age at study initiation: volunteers aged 25-35 were chosen
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- No data
- Duration of treatment / exposure:
- Single exposure
- Frequency of treatment:
- Once
- Post exposure period:
- Yes, 168 hrs
Doses / concentrations
- Dose / conc.:
- 3 other: g
- No. of animals per sex per dose:
- 5
- Positive control(s):
- No data
Examinations
- Tissues and cell types examined:
- blood lymphocytes
- Details of tissue and slide preparation:
- Two cultures were performed from each sample; 0.5 ml blood was added to Ham's F-10 medium and cultured for 48 h. Metaphase slides were prepared, stained in the usual way [6] and coded by an independent technician. From each culture, 250 metaphases (500 per point) were examined blindly for the presence of structural chromatid and chromosome aberrations. Only cells with 44-46 centromeres were taken into consideration. The mitotic index at 48 h was also determined to detect possible effects of treatment on cell proliferation.
- Statistics:
- ANOVA analysis does not indicate a statistically significant effect of paracetamol on the mitotic index in volunteers .
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No data
Applicant's summary and conclusion
- Conclusions:
- The ability of paracetamol to induce structural chromosome aberrations in human peripheral blood lymphocytes in vivo was evaluated in volunteers who had been administered a single oral dose of 3 g paracetamol.The patients were observed before treatments and 168hr after treatment.Our observations on volunteers receiving 3 g of paracetamol failed to detect any increase of structural chromosome aberrations in peripheral blood lymphocytes.
- Executive summary:
The ability of paracetamol to induce structural chromosome aberrations in human peripheral blood lymphocytes in vivo was evaluated in volunteers who had been administered a single oral dose of 3 g paracetamol.The patients were observed before treatments and 168hr after treatment.Our observations on volunteers receiving 3 g of paracetamol failed to detect any increase of structural chromosome aberrations in peripheral blood lymphocytes. Thus, it is highly unlikely that paracetamol can produce chromosome aberrations in vivo in man and that "there is no unacceptable (if any) mutagenic/carcinogenic risk associated with a sensible use of paracetamol as an analgesic agent".
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