Registration Dossier
Registration Dossier
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EC number: 201-494-2 | CAS number: 83-67-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- No data on test method. No data on GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- No data on method.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
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:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: Theobromine- Physical state: Hard white crystal powder- Other: odorless, bitter taste.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Control animals:
- not specified
- Details on study design:
- - Other examinations performed: post-mortem examination.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 837 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 837 ± 175 mg/kg b.w.
- Sex:
- not specified
- Dose descriptor:
- other: LD16
- Effect level:
- 320 mg/kg bw
- Based on:
- test mat.
- Sex:
- not specified
- Dose descriptor:
- other: LD84
- Effect level:
- 1 370 mg/kg bw
- Based on:
- test mat.
- Other findings:
- Abrupt hemodynamic changes: congestion, dilatation of the capillaries, perivascular edema, erythrocytes in the alveolar cavity.Degenerative changes were found in the liver and kidneys.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Based on EU criteria
- Conclusions:
- The oral LD50 in mouse is 837 ± 175 mg/kg b.w.
- Executive summary:
The oral acute toxicity of the test substance was determined following a method similar to OECD Guideline 401 without GLP. Theobromine was tested in mouse and several hemodynamic changes were observed. The LD50 of theobromine is 837 ± 175 mg/kg body weight.
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