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
2 study endpoints found for Phenolphthalein. 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 |
|---|---|---|---|---|---|
| NOEL | 6000 ppm | oral | rat | oral | REACH |
| NOEL | 100000 ppm | oral | rat | oral | REACH |
Expert Verdict
Phenolphthalein is prohibited in EU cosmetics as a Carcinogen Category 1B and Mutagen Category 2, with associated animal toxicity data. FDA removed it from OTC laxatives in 1999. Do not formulate.
Regulatory Flags
Frequently Asked Questions
Is Phenolphthalein safe in cosmetics?
Phenolphthalein is prohibited in EU cosmetics as a Carcinogen Category 1B and Mutagen Category 2, with associated animal toxicity data. FDA removed it from OTC laxatives in 1999. Do not formulate. The EU classifies Phenolphthalein as "prohibited". Safety rating: POOR. 2 toxicological study endpoint(s) are available in our database.
Is Phenolphthalein allowed in the EU?
Phenolphthalein EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Phenolphthalein do in cosmetics?
Phenolphthalein functions as: pH indicator. It is classified as a cosmetic ingredient in our database. CAS number: 77-09-8.
What is the Margin of Safety for Phenolphthalein?
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 Phenolphthalein?
The NOAEL (No Observed Adverse Effect Level) for Phenolphthalein is 6000 ppm based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.
Compliance Tools
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Related Ingredients
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