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Annex II Entry 394 20/10/2010

Tetrahydrozoline (Tetryzoline (INN)) and its salts

Tetrahydrozoline (Tetryzoline (INN)) and its salts 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: 394

Chemical identity and properties

PubChem 2D chemical structure for CAS 522-48-5
CAS 522-48-5PubChem CID 10648

Tetrahydrozoline Hydrochloride

Tetrahydrozoline hydrochloride is the hydrochloride salt of tetryzoline. It is used as a nasal decongestant. It has a role as a sympathomimetic agent, a vasoconstrictor agent and a nasal decongestant. It contains a tetryzoline(1+). — ChEBI

IUPAC name
2-(1,2,3,4-tetrahydronaphthalen-1-yl)-4,5-dihydro-1H-imidazole;hydrochloride
Molecular formula
C13H17ClN2
Molecular weight
236.74 g/mol
Exact mass
236.1080262 Da
Topological polar surface area
24.4 Ų
Hydrogen-bond donors
2
Hydrogen-bond acceptors
1
Covalent units
2
Defined stereocentres
0

Also known as

Tetrahydrozoline HClTetryzoline hydrochlorideTyzineVasoposTyzanol hydrochlorideRhinopront0YZT43HS7DNSC-757339
16 more reported names
2-(1,2,3,4-Tetrahydro-1-naphthyl)-2-imidazoline hydrochloride2-(1,2,3,4-Tetrahydro-1-naphthyl)-2-imidazoline monohydrochloride1H-Imidazole, 4,5-dihydro-2-(1,2,3,4-tetrahydro-1-naphthalenyl)-, monohydrochlorideCHEBI:9492Redness RelieverT-raojoEquate Eye DropsDg Health OriginalTetrahydrozoline HCIQC Sterile Red EyeMeijer Redness ReliefPremier Value OriginalDG Original Eye DropsEquate Redness RelieverVisine Red Eye ComfortRefChem:56118
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.

PubChem 2D chemical structure for CAS 84-22-0
CAS 84-22-0PubChem CID 5419

(+-)-Tetrahydrozoline

Tetryzoline is a carboxamidine and a member of imidazolines. It has a role as a sympathomimetic agent and a nasal decongestant. It is a conjugate base of a tetryzoline(1+). — ChEBI

IUPAC name
2-(1,2,3,4-tetrahydronaphthalen-1-yl)-4,5-dihydro-1H-imidazole
Molecular formula
C13H16N2
Molecular weight
200.28 g/mol
Exact mass
200.131348519 Da
XLogP3
1.8
Topological polar surface area
24.4 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
1
Covalent units
1
Defined stereocentres
0

Also known as

tetrahydrozolineTetryzolineTetryzolinumTetrizolina2-(1,2,3,4-Tetrahydro-1-naphthyl)-2-imidazoline2-Tetralin-1-yl-4,5-dihydro-1H-imidazole2-IMIDAZOLINE, 2-(1,2,3,4-TETRAHYDRO-1-NAPHTHYL)-S9U025Y077
16 more reported names
4,5-dihydro-2-(1,2,3,4-tetrahydro-1-naphthalenyl)-1H-imidazoleCHEBI:28674tetrahydrozeline nitratetetrahydrozeline hydrochlorideRefChem:390786R01AA06R01AB03S01GA02201-522-3TetryzolinTyzanol(-)-TetrahydrozolineCaltheonHSDB 7471UNII-S9U025Y077Tetryzoline, (-)-
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

Tetrahydrozoline (Tetryzoline (INN)) and its salts

Regulatory information

Regulation

(EC) 2009/1223

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SCCS opinions

Key data

CAS
84-22-0 / 522-48-5 / 33067-94-6
EC
201-522-3 / 208-329-3
Annex
II
Entry number
394

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

Annex II 393
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Acetonitrile

CAS: 75-05-8
EC: 200-835-2
Annex II 399
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Lidocaine (INN)

CAS: 137-58-6
EC: 205-302-8
Annex II 400
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1,2-Epoxybutane

CAS: 106-88-7
EC: 203-438-2

What Annex II means for Tetrahydrozoline (Tetryzoline (INN)) and its salts

Tetrahydrozoline (Tetryzoline (INN)) and its salts 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. Tetrahydrozoline (Tetryzoline (INN)) and its salts 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 84-22-0 / 522-48-5 / 33067-94-6 is the unique numerical identifier assigned to Tetrahydrozoline (Tetryzoline (INN)) and its salts 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 Tetrahydrozoline (Tetryzoline (INN)) and its salts

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

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