Good Preservative Sensitization Data

Chloroxylenol (PCMX)

Also known as: 4-Chloro-3,5-xylenol, BRN 1862539, Caswell No. 218, 2-Chloro-m-xylenol, Chlorxylenolum (+14 more)

INCI: CHLOROXYLENOL

Chloroxylenol (PCMX) (CAS 88-04-0) is a cosmetic preservative functioning as Preservative. EU Regulation 1223/2009 status: restricted, max 0.5%. 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 88-04-0 →

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

Chemistry & Identifiers

Formula
C8H9ClO
MW
156.61 g/mol
EC Number
201-793-8
PubChem CID
2723
IUPAC Name
4-chloro-3,5-dimethylphenol
InChIKey
OSDLLIBGSJNGJE-UHFFFAOYSA-N

Regulatory Status

EU EU Status restricted
EU Max Conc. 0.5%
US US Status restricted
US Notes CIR Expert Panel 2022 Re-review Summary

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Chloroxylenol (PCMX).

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Chloroxylenol (PCMX) based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.3%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: ESSCA; IVDK; NACDG

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
LOEL =25 % Mouse dermal short-term ECOTOX
NOEL =10 % Mouse dermal short-term ECOTOX
LEL =284 mg/kg-day Mouse dermal subchronic ToxRefDB
LEL =213 mg/kg-day Mouse dermal subchronic ToxRefDB
LOAEL =284 mg/kg-day Mouse dermal subchronic ToxRefDB
LOAEL =213 mg/kg-day Mouse dermal subchronic ToxRefDB
LD50 >=2000 mg/kg Rat oral - ECHA IUCLID
LEL =7900 mg/m3 Rat inhalation - ECHA IUCLID
NOEL =1000 mg/kg-day Rat oral - ECHA IUCLID
LEL =300 mg/kg-day Rat oral short-term (developmental) ToxRefDB

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

HRIPT Human Patch Test Studies

4 human repeat insult patch tests aggregated from dermatological literature.

Test Type N Sensitized Dose µg/cm² NESIL µg/cm² Potency
HRIPT - 0 3487.51 - -
HRIPT - 0 6975.01 - -
HRIPT - 0 22500 - -
HRIPT - 0 13950.03 - -

Endocrine Disruptor Evidence (Expanded)

Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.

Cosmetic-Specific Mechanism
Category: preservative
Receptor targets: ERα, TR
LOEC: 1 µM
EU status: allowed (max 0.5%)

weak agonist/antagonist

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
1 - 10 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)

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.

KR Korea MFDS Annex 2 (Restricted)
Category: Preservative. Max: 0.5%. —
JPKR Japan/Korea Cosmetics
Japan (Positive (Preservative)): max 0.20
Japan (Restricted): max Wash-away: 0.30% | Leave-on: 0.20% | Mucosa: 0.20%
Additional Jurisdictional Restrictions (5)
Jurisdiction Status Max % Product Type
JP restricted Wash-away: 0.30% | Leave-on: 0.20% | Mucosa: 0.20% Wash-away: 0.30% | Leave-on: 0.20% | Mucosa: 0.20%
CN permitted_preservative 0.5 All cosmetics
IN permitted_preservative 0.5 all cosmetics
BR permitted_preservative 0.5 -
ASEAN permitted_preservative 0.5% All products

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Roberts Skin Permeation (Mendeley 2022)
MW: 156.6
Log Kow: 3.35
Log Kp: -1.2287536009528295
Log Jmax: -6.95

Source: Roberts_Cheruvu_Mendeley_2022

Additional Ingredient Properties

1 property record from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "preservative", "patch_test_frequency_pct": "0.3", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA; IVDK; NACDG"}

PubChem Annotations

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

Safety (1)
Skin Eye Respiratory Irritation
Chloroxylenol /is listed as one of/ common contact allergens /in/ antiseptics. /from Table/
Source: Hazardous Substances Data Bank (HSDB)

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Biocide Fragrance Preservative
Regulatory List Membership (4)
EU Regulated in Personal Care IFRA Fragrance Transparency List FDA Indirect Food Contact Additives EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Chloroxylenol (PCMX).

Regulatory Flags

EU Restricted ifra_fragrance eu_cosing_listed

Known Synonyms

4-Chloro-3,5-xylenol BRN 1862539 Caswell No. 218 2-Chloro-m-xylenol Chlorxylenolum Dettol, liquid antiseptic EINECS 201-793-8 EPA Pesticide Chemical Code 086801 Husept Extra Nipacide MX Ottasept Extra Septiderm-Hydrochloride Willenol V Chloroxylenolum Clorossilenolo UNII-0F32U78V2Q Vionexus 4-chloro-1-hydroxy-3,5-dimethylbenzene 4-chloro-m-xylenol

Chemical Function

Biocide Preservative Fragrance

Regulatory Lists

active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides pharmaceutical CEDI Indirect additives food contact (10/2018) active_ingredient; Europe; Pesticides Europe; Personal care inert_ingredient; non_food_use; Pesticides IFRA Transparency

Australian Status

AICIS status: listed

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
CHLOROXYLENOL
ChEMBL ID
CHEMBL398440
Max Phase
2
Adverse Event Associations
268
View full pharmaceutical profile →

Frequently Asked Questions

Is Chloroxylenol (PCMX) safe in cosmetics?

Chloroxylenol (PCMX) has a safety rating of "GOOD" in our database. EU status: restricted. US status: restricted.

Is Chloroxylenol (PCMX) allowed in the EU?

Chloroxylenol (PCMX) EU regulatory status: restricted. Maximum allowed concentration: 0.5%. This is based on EU Regulation 1223/2009 and its amendments.

What does Chloroxylenol (PCMX) do in cosmetics?

Chloroxylenol (PCMX) functions as: Preservative. It is classified as a Preservative in our database. CAS number: 88-04-0.

Is Chloroxylenol (PCMX) used outside cosmetics?

Chloroxylenol (PCMX) 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.

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