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
9 study endpoints found for Tromethamine. 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 | 500 mg/kg bw/day | intravenous | rabbit | other | REACH |
| NOAEL | 250 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 186 mg/kg bw/day | intravenous | rabbit | other | REACH |
| NOAEL | 4000 mg/kg bw/day | oral | dog | oral | REACH |
| LOAEL | 1500 mg/kg bw/day | other | rat | other | REACH |
| NOAEL | >=2000 other | oral | rat | oral | REACH |
| NOAEL | 4000 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 930 mg/kg bw/day | intravenous | mouse | other | REACH |
| LOAEL | 1470 mg/kg bw/day | intravenous | rabbit | other | REACH |
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
ous safety assessment of aminomethyl propanediol. The Panel concluded that tromethamine, aminomethyl propanediol, and aminoethyl propanediol are safe in cosmetics in the practices of use and concentration as given in this safety assessment. Keywords cosmetics, safety, tromethamine Introduction The Cosmetic Ingredient Review (CIR) Expert Panel (Pan
Expert Verdict
Pure base solution is highly alkaline (pH 10.0 at ~100%); must avoid nitrosamine formation; erodes ordinary glass — use alkaline-resistant containers
Regulatory Flags
Frequently Asked Questions
Is Tromethamine safe in cosmetics?
Pure base solution is highly alkaline (pH 10.0 at ~100%); must avoid nitrosamine formation; erodes ordinary glass — use alkaline-resistant containers The EU classifies Tromethamine as "permitted". Safety rating: EXCELLENT. 9 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.
Is Tromethamine allowed in the EU?
Tromethamine EU regulatory status: permitted. Maximum allowed concentration: 0.5%. This is based on EU Regulation 1223/2009 and its amendments.
What does Tromethamine do in cosmetics?
Tromethamine functions as: pH adjuster, buffering agent, fragrance ingredient. It is classified as a cosmetic ingredient in our database. CAS number: 77-86-1.
What is the Margin of Safety for Tromethamine?
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 Tromethamine?
The NOAEL (No Observed Adverse Effect Level) for Tromethamine is 500 mg/kg bw/day based on a other study via intravenous route in rabbit. A total of 9 study endpoints are available. Source: REACH.
Compliance Tools
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Related Ingredients
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