Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Theobromine. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 800 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 75 mg/kg bw/day | oral | rabbit | Developmental | COSMOS_DB |
| NOAEL | 21 mg/kg bw/day | oral | rabbit | Developmental | COSMOS_DB |
| NOAEL | 53 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 1500 mg/kg bw/day | oral | mouse | Short Term Toxicity | COSMOS_DB |
| NOAEL | 375 mg/kg bw/day | oral | mouse | Reproductive | COSMOS_DB |
| NOAEL | 750 mg/kg bw/day | oral | mouse | Reproductive | COSMOS_DB |
| NOAEL | 88.2 mg/kg bw/day | oral | rabbit | Subchronic | COSMOS_DB |
| NOAEL | 250 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 250 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
Expert Verdict
Pharmacologically active vasodilator and diuretic at systemic levels; ensure use concentrations remain within CIR-reviewed range.
Regulatory Flags
Frequently Asked Questions
Is Theobromine safe in cosmetics?
Pharmacologically active vasodilator and diuretic at systemic levels; ensure use concentrations remain within CIR-reviewed range. The EU classifies Theobromine as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.
Is Theobromine allowed in the EU?
Theobromine EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Theobromine do in cosmetics?
Theobromine functions as: Skin-conditioning agent (methylxanthine class, related to caffeine and theophylline). It is classified as a cosmetic ingredient in our database. CAS number: 83-67-0.
What is the Margin of Safety for Theobromine?
adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
What is the NOAEL for Theobromine?
The NOAEL (No Observed Adverse Effect Level) for Theobromine is 800 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
Check Theobromine compliance across multiple jurisdictions:
Related Ingredients
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