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Toxicological information

Acute Toxicity: oral

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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:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
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.

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.