Registration Dossier

Administrative data

Description of key information

Weight of evidence: The oral LD50 for thebromine was determined to be between 837 mg/kg and 1265 mb/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Details on study design:
- Other examinations performed: post-mortem examination.
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.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
837 mg/kg bw
Quality of whole database:
Diverse oral-DL50 from handbooks, secondary literature and publications are taken as a weight of evidence. The results of the whole database lead to the same classification of the substance according to CLP regulation, the oral-DL50 is in accordance with the doses used in repeated dose toxicity studies.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Weight of evidence: Several secondary source and publications of Klimisch 3 and 4 (no data on the method) is available for Theobromine. This results range from 837 mg/kg bw in mouse to 1265 mb/kg bw in rats. This information leads to the classification of the substance as Acute oral toxicity Category 4, H302 according to CLP Regulation (EC) no. 1272/2008. Based on this information, no further testing is deemed necessary.

Justification for classification or non-classification

Based on the available data (LD50 between 837 and 1265 mg/kg bw), theobromine is classified for Acute oral toxicity Category 4, H302 according to CLP Regulation (EC) 1272/2008.