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EC number: 201-494-2 | CAS number: 83-67-0
- 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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: No guideline followed. No data on GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
- Type of method:
- in vivo
Test material
- Reference substance name:
- Theobromine
- EC Number:
- 201-494-2
- EC Name:
- Theobromine
- Cas Number:
- 83-67-0
- Molecular formula:
- C7H8N4O2
- IUPAC Name:
- theobromine
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Theobromine.- Other: Theobromine was purchased from Fisher Scientific Co. (Itasca, IL)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Weight at study initiation: 230 to 250 g.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 5% gum acacia
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 31 days.
- Frequency of treatment:
- Daily.
- Duration of test:
- 32 days.
Doses / concentrations
- Dose / conc.:
- 250 mg/kg bw/day
- No. of animals per sex per dose:
- 4 males per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The study was designed in order to compare the known toxic effects of theobromine alone in the reproductive male tract with toxic effects of the same amount of theobromine in a standardized cacao extract. For the present toxicity assessment only data concerning theobromine alone is presented in this study summary.
- Statistics:
- ANOVA with Sheffe's test for significance were used to determine the P values for the reproductive tract parameters. Fisher's two-tailed test was used to examine the significance of testis morphologic alterations.
Results and discussion
Effect levels
- Dose descriptor:
- dose level: 250 mg theobromine/ kg bdy weight
- Effect level:
- >= 250
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Decreased body weight gain, decrease in epididymal weight, different histopathological changes.
Observed effects
Any other information on results incl. tables
Table 1. Reproductive tract parameters of rats treated with 250mg/kg theobromine for 31 days
|
Control (n = 4) |
TB 250 (n = 4) |
Testis wt (g) |
1.76 ± 0.20 |
1.64 ± 0.17 |
Testis wt/BW (*10-3) |
4.20 ± 0.57 |
4.50 ± 0.49 |
Epidid. wt (g) |
0.56 ± 0.04 |
0.46 ± 0.02* |
Epidid. wt /BW (*10-3) |
1.33 ± 0.13 |
1.26 ± 0.05 |
Cauda epi dwt (g) |
0.27 ± 0.02 |
0.22 ± 0.01 |
Sperm count (*106) |
236.3 ± 88.6 |
131.3 ± 28.9 |
Sperm count /cauda epi dwt (*106) |
889.5 ± 375.7 |
605.1 ± 121.2 |
* P < 0.05.
Table 2. Testicular damage of rats treated with 250 mg/kg theobromine for 31 days.
|
Control (n=4) |
TB250 (n=4) |
Number ST counted |
235 |
253 |
Total number of vacuolations |
0 |
113 |
Number of vacuo/ST |
0 |
0.45 |
Number of ST with vacuolations |
0 |
46 |
Number of stage I to VIII ST with vacuo |
0 |
37 |
Total number of MNC |
0 |
23 |
Number of ST with MNC |
0 |
18 |
Number of ST with failed release |
0 |
20 |
ST = seminiferous tubule.
MnC = multinuclate cells.
Vacuo = vacuolation.
Applicant's summary and conclusion
- Conclusions:
- The tested dose of theobromine (250 mg/kg) produced numerous alterations in the reproductive male tract of treated rats.
- Executive summary:
The study was designed in order to compare the known toxic effects of theobromine alone in the reproductive male tract with toxic effects of the same amount of theobromine in a standardized cacao extract. Theobromine was administered by gavage to 4 rats in a concentration of 250 mg/kg for 31 days. The animals were sacrificed on day 32. One testis and epididymis were removed and weighed. The epididymis was saved for the determination of epididymal sperm reserves. The remaining testis was fixed by whole body glutaraldehyde perfusion and processed for morphologic examination. Theobromine caused numerous alterations in the reproductive male tract of the treated rats.
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