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EC number: 202-086-7 | CAS number: 91-64-5
- 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
Data source
Referenceopen allclose all
- Title:
- Toxicology and Carcinogenesis studies of coumarin in F344/N rats and B6C3F1 mice
- Author:
- US Dept. of health and human services
- Year:
- 1 993
- Bibliographic source:
- National Toxicology Program TR 422
- Title:
- No information
- Author:
- IARC
- Year:
- 2 000
- Bibliographic source:
- IARC volume 77-9 (2000), monograph on coumarin
Materials and methods
Test guideline
- Guideline:
- other: see attached IARC monograph and NTP TR422 study on coumarin
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Coumarin
- EC Number:
- 202-086-7
- EC Name:
- Coumarin
- Cas Number:
- 91-64-5
- Molecular formula:
- C9H6O2
- IUPAC Name:
- 2H-chromen-2-one
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 103 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 25, 50 and 100 mg/kg/d
Basis:
nominal in diet
- No. of animals per sex per dose:
- 60
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- T25
- Effect level:
- > 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable
- Remarks:
- no T25 identified. Effect type:carcinogenicity (migrated information)
Any other information on results incl. tables
Groups of 60 male and 60 female Fischer 344/N rats, six to seven weeks of age, were
administered coumarin (purity, > 97%) in corn oil by oral gavage at doses of 0, 25, 50
and 100 mg/kg bw daily for 103 weeks. Survival of low-, mid- and high-dose males
(9/50, 2/50 and 0/50 respectively) was significantly lower (p < 0.001) than that of
controls (28/50), as was body weight gain. In males, increased mortality was attributed
to increased severity of age-related spontaneous chronic progressive nephropathy. As
shown in Table 2, there was no increased incidence of renal tubule adenomas after
conventional single-section evaluation, but the incidence was increased based on the
results of step-sectioning of kidney tissue, although there was no dose–response
relationship. There was an increased severity of bile duct hyperplasia and renal tubule
hyperplasia in both sexes. An accompanying stop-exposure study was carried out in
which groups of 20 male rats received 100 mg/kg bw per day of coumarin by gavage in
corn oil for nine or 15 months followed by corn oil gavage only until the end of the study
at 103 weeks. Survival was 9/20 and 2/20 in the two groups, respectively. Whereas
hepatic lesions including bile duct hyperplasia were reversible and the incidence of renal
tubule adenomas, based on single sections, was not significantly increased, there was an
increase in the nine-month 100 mg/kg bw dose group after step-sectioning of the kidney
(National Toxicology Program, 1993). [The Working Group noted that the incidence of
renal tubule tumours was not increased after conventional examination of the kidney.]
Applicant's summary and conclusion
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