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.
US NotesExempt from CIR review due to existing FDA regulation. CIR has reviewed related compounds chlorophene and dichlorophene (data insufficient for safety).
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Hexachlorophene.
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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.
H410Very 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: 1BHuman: 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.
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 CosmeticsEU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Hexachlorophene.
Regulatory Flags
EU Restrictedendocrine_disruptoreu_banned_cosmeticseu_cosing_listed
Chemical Function
Preservative
Regulatory Lists
banned; Europe; Personal careEurope; nondetect; Other direct contact consumer goodsactive_ingredient; Europe; Pesticidespharmaceuticalactive_ingredient; Europe; Pesticidesactive_ingredient; Pesticidesactive_ingredient; PesticidesCanada; pharmaceuticalCanada; pharmaceutical
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCEChEMBL / DrugCentral / FAERSDB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
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