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
6 study endpoints found for Theophylline. 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 |
|---|---|---|---|---|---|
| LOAEL | 37.5 mg/kg bw/day | oral | rat | oral | REACH |
| LOAEL | 75 mg/kg bw/day | oral | rat | oral | REACH |
| LOAEL | ca.7.5 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 75 mg/kg bw/day | oral | mouse | oral | REACH |
| LOAEL | 225 mg/kg bw/day | oral | mouse | oral | REACH |
| NOAEL | ca.7.5 mg/kg bw/day | oral | mouse | oral | REACH |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Expert Verdict
CRITICAL: Classified as CMR substance in EU. Prohibited in Canada and ASEAN markets as well . Developmental toxicity concern via oral exposure identified by AICIS . Do NOT formulate for EU, ASEAN, or Canadian markets. US-only use requires strict concentration limits per CIR assessment
Regulatory Flags
Frequently Asked Questions
Is Theophylline safe in cosmetics?
CRITICAL: Classified as CMR substance in EU. Prohibited in Canada and ASEAN markets as well . Developmental toxicity concern via oral exposure identified by AICIS . Do NOT formulate for EU, ASEAN, or Canadian markets. US-only use requires strict concentration limits per CIR assessment The EU classifies Theophylline as "prohibited". Safety rating: MODERATE. 6 toxicological study endpoint(s) are available in our database.
Is Theophylline allowed in the EU?
Theophylline EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Theophylline do in cosmetics?
Theophylline functions as: Skin conditioning agent (methylxanthine; promotes microcirculation, lipolysis). It is classified as a cosmetic ingredient in our database. CAS number: 58-55-9.
What is the Margin of Safety for Theophylline?
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 Theophylline?
The NOAEL (No Observed Adverse Effect Level) for Theophylline is 37.5 mg/kg bw/day based on a oral study via oral route in rat. A total of 6 study endpoints are available. Source: REACH.
Is Theophylline classified as hazardous under GHS?
Theophylline carries a GHS signal word of "DANGER". Hazard statements: Toxic if swallowed May be harmful if inhaled May cause harm to breast-fed children Causes damage to vascular system and kidneys Causes damage to the kidneys through prolonged or repeated exposure. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.
Compliance Tools
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Related Ingredients
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