Moderate Preservative Sensitization Data

Hexachlorophene

INCI: HEXACHLOROPHENE

Hexachlorophene (CAS 70-30-4) is a cosmetic preservative functioning as Preservative. EU Regulation 1223/2009 status: restricted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.

View industrial chemical safety profile for CAS 70-30-4 →

Auto-generated CPSR Part A draft with source citations
Function
Preservative
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C13H6Cl6O2
MW
406.9 g/mol
PubChem CID
3598
IUPAC Name
3,4,6-trichloro-2-[(2,3,5-trichloro-6-hydroxyphenyl)methyl]phenol
InChIKey
ACGUYXCXAPNIKK-UHFFFAOYSA-N

Regulatory Status

EU EU Status restricted
US US Status permitted
US Notes Exempt from CIR review due to existing FDA regulation. CIR has reviewed related compounds chlorophene and dichlorophene (data insufficient for safety).

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Hexachlorophene based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: IVDK; SCCS

IARC Carcinogenicity

International Agency for Research on Cancer (WHO) monograph evaluation.

IARC Group
3
Volume
20, Sup 7
Evaluation Year
1987

EU CLP Annex VI Harmonized Classification

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

Signal Word
Danger
Pictograms
Acute ToxicityEnvironmental Hazard
Hazard Class and Category
Acute Tox. 3 *; Acute Tox. 3 *; Aquatic Acute 1; Aquatic Chronic 1
Hazard Statements
  • H311 Toxic in contact with skin
  • H301 Toxic if swallowed
  • H400 Very toxic to aquatic life
  • H410 Very toxic to aquatic life with long lasting effects
Specific Concentration Limits / M-factors
*

Inserted via ATP: CLP00

Sensitization AOP Dashboard

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

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

Source: HPPT: [228] Marzulli FN and Maibach HI (1973): https://library.scconline.org/v024n07/

HRIPT Human Patch Test Studies

5 human repeat insult patch tests aggregated from dermatological literature.

Test Type N Sensitized Dose µg/cm² NESIL µg/cm² Potency
HMT - 0 6206.9 - -
HMT - 0 15517.24 - -
HMT - 0 15517.24 - -
HRIPT - 0 348.75 - -
HRIPT - 0 3487.51 - -

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex II — Prohibited
Ref: 371
(EC) 2009/1223

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)
ASEAN Cosmetic Directive (II)
Ref: 371
JPKR Japan/Korea Cosmetics
Japan (Prohibited): Must not be used
Korea (Prohibited): Must not be used
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
India: Restricted · max 1% w/w in soaps only; prohibited in all other cosmetics
Additional Jurisdictional Restrictions (8)
Jurisdiction Status Max % Product Type
JP banned - All cosmetics
CN banned - -
IN banned - all cosmetics except soap ≤1% w/w
IN restricted 1.0 toilet soap ONLY
BR banned - -
CA banned - -
ASEAN banned - All cosmetic products prohibited
KR prohibited - -

Additional Ingredient Properties

1 property record from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "preservative", "patch_test_frequency_pct": "0.2", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "IVDK; SCCS"}

PubChem Annotations

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

Safety (6)
Carcinogen Classification
Hexachlorophene | Group 3: Not classifiable as to its carcinogenicity to humans | Volume 20: (1979) Some Halogenated Hydrocarbons | Volume Sup 7: Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42, 1987; 440 pages; ISBN 92-832-1411-0 (out of print)
Source: International Agency for Research on Cancer (IARC)
Carcinogen Classification
Hexachlorophene | TR-040: Bioassay of Hexachlorophene for Possible Carcinogenicity (CASRN 70-30-4) (1978 ) | 11/28/78 | No Evidence | No Evidence | Chemical Not Tested in Species/Sex | Chemical Not Tested in Species/Sex | It is concluded that under the conditions of this bioassay, hexachlorophene did not induce malignant or benign tumors in Fischer 344 rats.
Source: NTP Technical Reports
Evidence for Carcinogenicity
Classification of carcinogenicity: 1) evidence in humans: no data; 2) evidence in animals: inadequate. Overall summary evaluation of carcinogenic risk to humans is Group 3: The agent is not classifiable as to its carcinogenicity to humans. /From table/
Source: Hazardous Substances Data Bank (HSDB)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
ICSC Safety Card
0161
Source: ILO-WHO International Chemical Safety Cards (ICSCs)

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Preservative
Regulatory List Membership (2)
EU Banned in Cosmetics EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Hexachlorophene.

Regulatory Flags

EU Restricted endocrine_disruptor eu_banned_cosmetics eu_cosing_listed

Chemical Function

Preservative

Regulatory Lists

banned; Europe; Personal care Europe; nondetect; Other direct contact consumer goods active_ingredient; Europe; Pesticides pharmaceutical active_ingredient; Europe; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides Canada; pharmaceutical Canada; pharmaceutical

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
HEXACHLOROPHENE
ChEMBL ID
CHEMBL496
Max Phase
4
Adverse Event Associations
22
View full pharmaceutical profile →

Frequently Asked Questions

Is Hexachlorophene safe in cosmetics?

Hexachlorophene has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted.

Is Hexachlorophene allowed in the EU?

Hexachlorophene EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does Hexachlorophene do in cosmetics?

Hexachlorophene functions as: Preservative. It is classified as a Preservative in our database. CAS number: 70-30-4.

Is Hexachlorophene used outside cosmetics?

Hexachlorophene also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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