Is Phenolphthalein safe in cosmetics?
Phenolphthalein has a safety rating of "POOR" in our database. EU status: prohibited. US status: prohibited.
Poor
Cosmetic Ingredient
Phenolphthalein
Also known as: 3,3-Bis(4-hydroxyphenyl)-2-benzofuran-1(3H)-one, 5-18-04-00188, BRN 0284423, Correctol, alpha-Di(p-hydroxyphenyl)phthalide (+15 more)
INCI: PHENOLPHTHALEIN
Phenolphthalein (CAS 77-09-8) is a cosmetic cosmetic ingredient functioning as pH indicator. EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 77-09-8 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Phenolphthalein is prohibited in EU cosmetics but has active industrial GHS classifications (H341, H350, H361, H361f, H317, H319, H351, H372).
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
pH indicator
Safety Rating
POOR
Chemistry & Identifiers
IUPAC Name
3,3-bis(4-hydroxyphenyl)-2-benzofuran-1-one
InChIKey
KJFMBFZCATUALV-UHFFFAOYSA-N
Regulatory Status
EU EU Status
prohibited
US US Status
prohibited
US Notes
FDA removed from OTC laxative use in 1999 due to carcinogenicity. Not explicitly banned in cosmetics but classified as a known carcinogen — use would trigger adulteration concerns.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Phenolphthalein.
Calculate MoS for your specific formulation with the MoS Calculator.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LEL | =11000 mg/kg-day | Rat | oral | short-term | ToxRefDB |
| LEL | =10500 mg/kg-day | Rat | oral | short-term | ToxRefDB |
| LEL | =15000 mg/kg-day | Mouse | oral | short-term | ToxRefDB |
| LEL | =15000 mg/kg-day | Mouse | oral | short-term | ToxRefDB |
| LEL | =1700 mg/kg-day | Rat | oral | subchronic | ToxRefDB |
| LEL | =800 mg/kg-day | Rat | oral | subchronic | ToxRefDB |
| LEL | =2400 mg/kg-day | Mouse | oral | subchronic | ToxRefDB |
| LEL | =500 mg/kg-day | Mouse | oral | subchronic | ToxRefDB |
| LEL | =500 mg/kg-day | Rat | oral | chronic | ToxRefDB |
| LEL | =500 mg/kg-day | Rat | oral | chronic | ToxRefDB |
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
2B
Volume
76
Evaluation Year
1999
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Health Hazard
Hazard Class and Category
Carc. 1B; Muta. 2; Repr. 2
Hazard Statements
- H350 May cause cancer
- H341 Suspected of causing genetic defects
- H361f ***
Specific Concentration Limits / M-factors
Carc. 1B; H350: C ≥ 1.0%
Inserted via ATP: ATP01corr
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE; GROUP
SVHC Candidate
Yes (since 19-Dec-2011)
Hazard classification: Restricted (Annex XVII)
SVHC reason: Carcinogenic (Article 57a)
Substance of Very High Concern (SVHC)
Included: 19-Dec-2011
Carcinogenic (Article 57a)
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 417
(EC) 2009/1223
CMR: Carcinogenic Cat. 1A(C=>1%),Carcinogenic Cat. 1B(),Mutagenic Cat. 2(),Reprotoxic Cat. 2()
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
SA Saudi SFDA (II - Prohibited)
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| IN | banned | - | all cosmetics |
| CA | banned | - | - |
| ASEAN | banned | - | All cosmetic products prohibited |
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (5)
Carcinogen Classification
2B, possibly carcinogenic to humans. (L135)
Source: Toxin and Toxin Target Database (T3DB)
Carcinogen Classification
Phenolphthalein | Group 2B: Possibly carcinogenic to humans | Volume 76: (2000) Some Antiviral and Antineoplastic Drugs, and Other Pharmaceutical Agents
Source: International Agency for Research on Cancer (IARC)
Carcinogen Classification
Phenolphthalein | TR-465: Toxicology and Carcinogenesis Studies of Phenolphthalein (CASRN 77-09-8) in F344/N Rats and B6C3F1 Mice (Feed Studies) (1996 ) | 12/05/95 | Clear Evidence | Some Evidence | Clear Evidence | Clear Evidence | Under the conditions of these 2-year feed studies, there was clear evidence of carcinogenic activity of phenolphthalein in male F344/N rats based on markedly
Source: NTP Technical Reports
Evidence for Carcinogenicity
Evaluation: There is inadequate evidence in humans for the carcinogenicity of phenolphthalein. There is sufficient evidence in experimental animals for the carcinogenicity of phenolphthalein. Overall evaluation: Phenolphthalein is possibly carcinogenic to humans (Group 2B) | Phenolphthalein: reasonably anticipated to be a human carcinogen.
Source: Hazardous Substances Data Bank (HSDB)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
Function Categories & List Membership
Cosmetic/Chemical Function Categories
No specific technical function
Regulatory List Membership (3)
California Proposition 65 (OEHHA)
EU Banned in Cosmetics
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Phenolphthalein.
Regulatory Flags
endocrine_disruptor
prop65
eu_banned_cosmetics
eu_cosing_listed
Known Synonyms
3,3-Bis(4-hydroxyphenyl)-2-benzofuran-1(3H)-one
5-18-04-00188
BRN 0284423
Correctol
alpha-Di(p-hydroxyphenyl)phthalide
Dihydroxyphthalophenone
EINECS 201-004-7
Espotabs
Evac-U-Gen
Evac-Q-Kit
Evac-Q-Kwik
Evac-V-Lax
Feen-A-Mint Gum
FemiLax
alpha-(p-Hydroxyphenyl)-alpha-(4-oxo-2,5-cyclohexadien-1-ylidene)-o-toluic acid
Lax-Pills
Medilax
NCI-C55798
Phenolax
Phthalide 3,3,-bis(p-hydroxyphenyl)-
Chemical Function
No specific technical function
Regulatory Lists
banned; Europe; Personal care
active_ingredient; Australia
pharmaceutical
OEHHA Proposition 65 (3/2019)
Canada; pharmaceutical
Canada; pharmaceutical
OEHHA Proposition 65 (1/2023)
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
PHENOLPHTHALEIN
ChEMBL ID
CHEMBL63857
Max Phase
4
Adverse Event Associations
115
Frequently Asked Questions
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.
Is Phenolphthalein used outside cosmetics?
Phenolphthalein also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Phenolphthalein have different safety status in cosmetics vs industrial chemicals?
Phenolphthalein is prohibited in EU cosmetics but has active industrial GHS classifications (H341, H350, H361, H361f, H317, H319, H351, H372).
Compliance Tools
Check Phenolphthalein compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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