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Annex II Entry 56 17/10/2010

Bretylium tosilate (INN)

Bretylium tosilate (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: 56

Chemical identity and properties

PubChem 2D chemical structure for CAS 61-75-6
CAS 61-75-6PubChem CID 6100

Bretylium Tosylate

Bretylium tosylate is the tosylate salt of bretylium. It blocks noradrenaline release from the peripheral sympathetic nervous system, and is used in emergency medicine, cardiology, and other specialties for the acute management of ventricular tachycardia and ventricular fibrillation. It has a role as an antihypertensive agent, an adrenergic antagonist and an anti-arrhythmia drug. It is a quaternary ammonium salt and an organosulfonate salt. It contains a bretylium. — ChEBI

IUPAC name
(2-bromophenyl)methyl-ethyl-dimethylazanium;4-methylbenzenesulfonate
Molecular formula
C18H24BrNO3S
Molecular weight
414.4 g/mol
Exact mass
413.06603 Da
Topological polar surface area
65.6 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
3
Covalent units
2
Defined stereocentres
0

Also known as

BretylolBretylium tosilateDarentinTosilato de bretilioTosilate de bretyliumBretylii tosilasASL-603(o-Bromobenzyl)ethyldimethylammonium p-toluenesulfonate
16 more reported names
Bretilio tosilatoBretylium Tosylate In Dextrose 5%NSC-621642-Bromo-N-ethyl-N,N-dimethylbenzenemethanaminium 4-methylbenzenesulfonateDimethylethyl-o-bromobenzylammonium-p-toluenesulphonateN-Ethyl-N-o-bromobenzyl-N,N-dimethylammonium tosylate78ZP3YR353Benzenemethanaminium, 2-bromo-N-ethyl-N,N-dimethyl-, salt with 4-methylbenzenesulfonic acid (1:1)CHEBI:3173BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINERbrAtylium (cation)RefChem:56963C01BD02200-516-8OrnidBretylate
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Chemical name

Bretylium tosilate (INN)

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Key data

CAS
61-75-6
EC
200-516-8
Annex
II
Entry number
56

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

Annex II 57
Nearby record in the same annex

Carbromal (INN)

CAS: 77-65-6
EC: 201-046-6
Annex II 62
Nearby record in the same annex

Brucine

CAS: 357-57-3
EC: 206-614-7

What Annex II means for Bretylium tosilate (INN)

Bretylium tosilate (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. Bretylium tosilate (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 61-75-6 is the unique numerical identifier assigned to Bretylium tosilate (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 Bretylium tosilate (INN)

This page summarizes one Annex II record for Bretylium tosilate (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 Bretylium tosilate (INN), but confirm any final regulatory decision against the current official annex wording and source files.

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