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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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.