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Annex II Entry 120 20/10/2010

N,N'-Pentamethylenebis(trimethylammonium) salts, e.g. pentamethonium bromide (INN)

N,N'-Pentamethylenebis(trimethylammonium) salts, e.g. pentamethonium bromide (INN) is listed in Annex II as a prohibited substance for cosmetic products placed on the EU market.

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Prohibited substance— Annex II, EU Regulation 1223/2009
Entry: 120

Chemical identity and properties

PubChem 2D chemical structure for CAS 541-20-8
CAS 541-20-8PubChem CID 10919

Pentamethonium Bromide

Pentamethonium bromide is the bromide salt of pentamethonium. It is a ganglion blocker and exhibits antihypertensive activity. It has a role as a vasodilator agent and an antihypertensive agent. It is a bromide salt and a quaternary ammonium salt. It contains a pentamethonium. — ChEBI

IUPAC name
trimethyl-[5-(trimethylazaniumyl)pentyl]azanium dibromide
Molecular formula
C11H28Br2N2
Molecular weight
348.16 g/mol
Exact mass
348.05987 Da
Topological polar surface area
0.0 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
2
Covalent units
3
Defined stereocentres
0

Also known as

LytensiumPentamethonium dibromideBromuro de pentametonioBromure de pentamethoniumPentamethonii bromidumPentametonio bromuroPentamethylenebis(trimethylammonium bromide)0UX03A6JJC
16 more reported names
alpha,omega-Bis(trimethylammonium)pentane dibromideNSC-148343CHEBI:134839Pentamethylenebis[trimethylammonium bromide]pentamAthonium (cation)RefChem:171394208-771-7PenthoniumC 5N1,N1,N1,N5,N5,N5-hexamethylpentane-1,5-diaminium bromideEINECS 208-771-7Pentametonio bromuro [DCIT]C 5 (VAN)Pentamethonium bromide [INN:BAN]Pentamethonii bromidum [INN-Latin]UNII-0UX03A6JJC
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Retrieved from NIH PubChem on 2026-09-02 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Chemical name

N,N'-Pentamethylenebis(trimethylammonium) salts, e.g. pentamethonium bromide (INN)

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Key data

CAS
541-20-8
EC
208-771-7
Annex
II
Entry number
120

Direct matches are limited for this record, so nearby entries from Annex II are shown as well.

What Annex II means for N,N'-Pentamethylenebis(trimethylammonium) salts, e.g. pentamethonium bromide (INN)

N,N'-Pentamethylenebis(trimethylammonium) salts, e.g. pentamethonium bromide (INN) is listed as a prohibited substance under Annex II of EU Cosmetics Regulation 1223/2009 and must not be intentionally added. Article 17 separately addresses unintended small quantities that are technically unavoidable under good manufacturing practice and compatible with the Article 3 safety requirement.

Formulators must screen their ingredients and raw materials to ensure none contain this substance. Suppliers should provide documentation confirming absence when requested.

The page also surfaces 12 related annex records with overlapping identifiers, annex logic or naming patterns.

Compliance checklist

  • Verify this substance is absent from all raw materials and finished formulations.
  • Request absence confirmation or CoA from raw material suppliers.
  • Document the screening result in the Product Information File (PIF).

Frequently asked questions

Yes. N,N'-Pentamethylenebis(trimethylammonium) salts, e.g. pentamethonium bromide (INN) is listed in Annex II of EU Cosmetics Regulation 1223/2009 and is prohibited as an intentionally added cosmetic ingredient. Article 17 provides a narrow exception for unintended small quantities that are technically unavoidable under good manufacturing practice, provided the product remains safe under Article 3.

CAS 541-20-8 is the unique numerical identifier assigned to N,N'-Pentamethylenebis(trimethylammonium) salts, e.g. pentamethonium bromide (INN) by the Chemical Abstracts Service. In cosmetic compliance work, the CAS number is used to cross-reference the substance across regulatory databases, raw material specifications and safety assessment reports. Multiple EU annex entries may share the same CAS number if the same substance appears under different conditions or in different annexes.

Use the INCI Checker tool on this site to paste your full ingredient list (INCI) and scan it against all Annex II–VI entries. The tool highlights any ingredients that match restricted, prohibited or allergen-flagged records. This is useful for rapid compliance screening of finished product formulas or raw material declarations.
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Source note for Annex II record N,N'-Pentamethylenebis(trimethylammonium) salts, e.g. pentamethonium bromide (INN)

This page summarizes one Annex II record for N,N'-Pentamethylenebis(trimethylammonium) salts, e.g. pentamethonium bromide (INN) from public European Commission cosmetic materials and adds linked inventory or identifier matches when available.

Use this record page to review Annex II conditions for N,N'-Pentamethylenebis(trimethylammonium) salts, e.g. pentamethonium bromide (INN), but confirm any final regulatory decision against the current official annex wording and source files.

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