Poor Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed

Dichlorophene

Also known as: 2,2'-Methylene-bis (4-chlorophenol), Anthiphen, Antifen, Antiphen, Bis(chlorohydroxyphenyl)methane (+15 more)

INCI: DICHLOROPHENE

Dichlorophene (CAS 97-23-4) is a cosmetic cosmetic ingredient functioning as Preservative, antimicrobial. Reported NOAEL =1 mg/kg/day in rabbit (CIR Safety Assessment); EU Regulation 1223/2009 status: prohibited, max 0.5%; 5 safety opinions reviewed (CIR Safety Assessment). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.

View industrial chemical safety profile for CAS 97-23-4 →

Auto-generated CPSR Part A draft with source citations
Function
Preservative, antimicrobial
Safety Rating
POOR

Chemistry & Identifiers

Formula
C13H10Cl2O2
MW
269.12 g/mol
PubChem CID
3037
IUPAC Name
4-chloro-2-[(5-chloro-2-hydroxyphenyl)methyl]phenol
InChIKey
MDNWOSOZYLHTCG-UHFFFAOYSA-N

Regulatory Status

EU EU Status prohibited
EU Max Conc. 0.5%
US US Status permitted
US Notes Permitted with CIR review. CIR Safety Assessment published; Int. J. Toxicol. 2004

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Dichlorophene.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Dichlorophene. 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 =1 mg/kg/day dermal rabbit NOAEL study CIR Safety Assessment
NOAEL =1 mg/kg/day dermal rabbit NOAEL study CIR Safety Assessment
NOAEL =1 mg/kg/day dermal rabbit NOAEL study CIR Safety Assessment
NOAEL =1 mg/kg/day dermal rabbit NOAEL study CIR Safety Assessment
NOAEL =25 mg/kg/day dermal rabbit NOAEL study CIR Safety Assessment
NOAEL =25 mg/kg/day dermal rabbit NOAEL study CIR Safety Assessment
NOAEL =25 mg/kg/day dermal rabbit NOAEL study CIR Safety Assessment
NOAEL =25 mg/kg/day dermal rabbit NOAEL study CIR Safety Assessment
NOAEL =30 mg/kg/day - rat developmental toxicity CIR Safety Assessment
NOAEL =30 mg/kg/day - rat developmental toxicity CIR Safety Assessment

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

CIR Safety Assessment 18 July 2003
Verdict: unknown
NOAEL: 120 mg/kg/day (oral)
CIR Safety Assessment 18 July 2003
Verdict: unknown
NOAEL: 100 mg/kg/day (oral)
CIR Safety Assessment 18 July 2003
Verdict: unknown
NOAEL: 900 mg/kg/day (oral)
CIR Safety Assessment 18 July 2003
Verdict: unknown
NOAEL: 100 mg/kg/day (not specified)
CIR Safety Assessment 18 July 2003
Verdict: unknown
NOAEL: 25 mg/kg/day (dermal)

EU CLP Annex VI Harmonized Classification

Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.

Signal Word
Warning
Pictograms
Harmful / IrritantEnvironmental Hazard
Hazard Class and Category
Acute Tox. 4 *; Eye Irrit. 2; Aquatic Acute 1; Aquatic Chronic 1
Hazard Statements
  • H302 Harmful if swallowed
  • H319 Causes serious eye irritation
  • H400 Very toxic to aquatic life
  • H410 Very toxic to aquatic life with long lasting effects

Inserted via ATP: CLP00

Sensitization AOP Dashboard

Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.

NESIL
3488 µg/cm²
GHS: 1B Human: positive

Source: HPPT: [28] Jordan Jr WP and King SE (1977): https://doi.org/10.1111/j.1600-0536.1977.tb03582.x

HRIPT Human Patch Test Studies

3 human repeat insult patch tests aggregated from dermatological literature.

Test Type N Sensitized Dose µg/cm² NESIL µg/cm² Potency
HRIPT - 0 5625 - -
HRIPT - 0 3487.51 - -
HRIPT - 0 13950.03 - -

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 (III - Restricted)
Max: 0.005.
JPKR Japan/Korea Cosmetics
Japan (Prohibited): Must not be used
BRIN Brazil/India Cosmetics
India: Restricted · max 0.005
Additional Jurisdictional Restrictions (4)
Jurisdiction Status Max % Product Type
JP banned - All cosmetics
BR restricted 0.5 -
ASEAN restricted 0.5% All products
KR prohibited - -

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Safety (1)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Biocide Deodorizer
Regulatory List Membership (3)
California Proposition 65 (OEHHA) FDA Indirect Food Contact Additives EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Dichlorophene.

Regulatory Flags

preservative prop65 eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Dichlorophene by CAS number or substance name.

Studies
24
Lowest NOAEL
1 mg/kg/day
Highest NOAEL
240 mg/kg/day
CIR Safety Assessment

Known Synonyms

2,2'-Methylene-bis (4-chlorophenol) Anthiphen Antifen Antiphen Bis(chlorohydroxyphenyl)methane Bis(5-chloro-2-hydroxyphenyl)methane Bis(2-hydroxy-5-chlorophenyl)methane BRN 1884514 Caswell No. 563 Cordocel DDM (VAN) Dicestal 5,5'-Dichloro-2,2'-dihydroxydiphenylmethane Dichlorofen Di-(5-chloro-2-hydroxyphenyl)methane 4,4'-Dichloro-2,2'-methylenediphenol Dichlorophen B Dichlorophene 10 Dichlorphen Didroxan

Chemical Function

Biocide Deodorizer

Regulatory Lists

Indirect additives food contact (10/2018) active_ingredient; Europe; Pesticides active_ingredient; Australia pharmaceutical active_ingredient; Europe; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides Europe; Personal care; restricted Europe; nondetect; Other direct contact consumer goods Canada; pharmaceutical inert_ingredient; non_food_use; Pesticides OEHHA Proposition 65 (3/2019) OEHHA Proposition 65 (1/2023)

Australian Status

AICIS status: listed

Frequently Asked Questions

Is Dichlorophene safe in cosmetics?

Dichlorophene has a safety rating of "POOR" in our database. EU status: prohibited. US status: permitted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by CIR Safety Assessment.

Is Dichlorophene allowed in the EU?

Dichlorophene EU regulatory status: prohibited. Maximum allowed concentration: 0.5%. This is based on EU Regulation 1223/2009 and its amendments.

What does Dichlorophene do in cosmetics?

Dichlorophene functions as: Preservative, antimicrobial. It is classified as a cosmetic ingredient in our database. CAS number: 97-23-4.

What is the NOAEL for Dichlorophene?

The NOAEL (No Observed Adverse Effect Level) for Dichlorophene is =1 mg/kg/day based on a NOAEL study study via dermal route in rabbit. A total of 10 study endpoints are available. Source: CIR Safety Assessment.

Is Dichlorophene used outside cosmetics?

Dichlorophene also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does Dichlorophene have different safety status in cosmetics vs industrial chemicals?

Dichlorophene is prohibited in EU cosmetics at max 0.5% but has active industrial GHS classifications (H302, H317, H318, H400, H410, H319, H226, H315).

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