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EC number: 305-748-4 | CAS number: 95009-22-6
- 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:
- genetic toxicity in vivo
- Remarks:
- Type of genotoxicity: other: gene mutation chromosome aberration DNA damage and/or repair
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The methods reasonably state the materials/animals used and sufficient detail to understand exactly what was done.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity of cocoa examined by microbial and mammalian systems
- Author:
- H. W. Renner and R. Münzner
- Year:
- 1 981
- Bibliographic source:
- Mutation Research, 103 (1982) 275-281
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- other: Not applicable
- Deviations:
- not applicable
- GLP compliance:
- no
- Type of assay:
- other: sister chromatid exchange assay in mammalian cells other: in vivo mammalian chromosome aberration test in vivo mammalian cell micronucleus test
Test material
- Reference substance name:
- Cocoa powder (fat free)
- IUPAC Name:
- Cocoa powder (fat free)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): cocoa powder roasted and unroasted, fat free (fat extracted with petroleum) cocoa butter
- Physical state: powder/solidsolid
- Analytical purity: no data, suitable for use in foodpuriss.
- Radiochemical purity (if radiolabelling): no data
- Specific activity (if radiolabelling): no data
- Locations of the label (if radiolabelling): no data
- Expiration date of radiochemical substance (if radiolabelling): no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other:
Constituent 1
Test animals
- Species:
- other: Species/strain: other: Chinese hamster polychromatic erythrocytes Chinese hamster bone marrow cells
Administration / exposure
- Route of administration:
- other: Stomach tube
- Vehicle:
- Water and Corn oil.
- Frequency of treatment:
- -dosage: theobromine – single dose, 2h after BrdU implantation; cocoa powder – 0.1 or 0.2 g/animal at the same time with the BrdU implantation, followed by 2 other administrations of 0.2 g each at 90 minutes intervals; (total doses 0.1; 0.3; 0.4 and 0.6g
Results and discussion
- Additional information on results:
- Species / strain:
other:
Chinese hamster polychromatic erythrocytes
Chinese hamster bone marrow cells
Metabolic activation:
with and without
Test system:
all strains/cell types tested
Genotoxicity:
Positive sister chromatid exchangeambiguous
Cytotoxicity:
no data
Vehicle controls valid:
not examined
Negative controls valid:
no data
Positive controls valid:
yes
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: The only result was a positive sister chromatid exchange (SCE) in vivo. No OECD method has been developed for this assay due to the high degree of variability in the results seen with the in vivo assay. The mechanisms driving the SCE are not known and an
The positive SCE was the only positive in vivo assay cocoa powder being negative in the in vivo mammalian chromosome aberration assay and the in vivo mammalian micronucleus assay. In the current ICH guidance on genotoxicity testing a negative in vivo micronucleus assay would be considered to be a good indication of a lack of genotoxicity with negative findings found in the in vitro assays (Ames, in vitro micronucleus or mouse lymphoma), This SCE positive result needs to be considered in the light of other studies. - Executive summary:
Unroasted or roasted cocoa powder dispersed in water and applied to Chinese hamsters by stomach tube caused elevated numbers of SCEs in the sister-chromatid exchange test (bone-marrow cells). Roasted cocoa freed from fat produced distinctly higher SCE values with a linear dose-response relationship, whereas cocoa butter had no influence on SCE levels. Positive results in the SCE test (1.5-fold values of the controls) were obtained after application of about 5 g cocoa/kg b.w. Positive test results were not found when cocoa was given in the diet instead of being administered by stomach tube. No evidence of genotoxicity was seen in the in vivo micronuclueus assay (max dose 0.6 g/animal) or in an in vivo mammalian chromosome aberration test (0.2 g/animal)The exact mechanisms driving the SCE assay are not known and an increase in SCE does not necessary indicate genotoxicity, which makes a positive result difficult to interpret on its own. This assay has an OECD guideline but only for the in vitro version of the test. The in vivo assay is no longer routinely performed.
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