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Annex II Entry 237 15/10/2010

Tefazoline (INN) and its salts

Tefazoline (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: 237

Chemical identity and properties

PubChem 2D chemical structure for CAS 1082-56-0
CAS 1082-56-0PubChem CID 163309

Tefazoline

Tefazoline is a small molecule drug. The usage of the INN stem '-azoline' in the name indicates that Tefazoline is a antihistaminic or local vasoconstrictor, antazoline derivative. Tefazoline has a monoisotopic molecular weight of 214.15 Da. — DrugBank

IUPAC name
2-(5,6,7,8-tetrahydronaphthalen-1-ylmethyl)-4,5-dihydro-1H-imidazole
Molecular formula
C14H18N2
Molecular weight
214.31 g/mol
Exact mass
214.146998583 Da
XLogP3
2.2
Topological polar surface area
24.4 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
1
Covalent units
1
Defined stereocentres
0

Also known as

TefazolinumTenaphtoxalinRhinodolTefazoline [INN:DCF]tefazolinaUNII-9738II2CCH9738II2CCHUCB 1109
9 more reported names
TEFAZOLINE [INN]TEFAZOLINE [MART.]5-(2'-Imidazolin-2'-ylmethyltetralin2-(1,2,3,4-Tetrahydro-5-naphthylmethyl)-2-imidazolin2-(5,6,7,8-Tetrahydro-1-naphthyl)methyl)-2-imidazolinTEFAZOLINE (MART.)RefChem:1877012-[(5,6,7,8-Tetrahydronaphthalen-1-yl)methyl]-4,5-dihydro-1H-imidazole2-((5,6,7,8-Tetrahydro-1-naphthyl)methyl)-2-imidazoline
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Evidence from additional scientific databases

NIH PubChem PUG-View
Exact identifier match163309

Attributed physical-property, hazard, environmental and use annotations.

Mapped by: Existing checksum-valid CAS to unique PubChem CID match. Retrieved: 2026-08-31. Open source record

Scientific classifications and hazard annotations provide context and do not replace the market-specific regulatory decision shown above.

Additional source coverage and match status
SourceResultChecked
NIH PubChem PUG-ViewExact match2026-08-31

A recorded no-match is useful evidence that the source was checked; it is not a claim that the substance does not exist elsewhere.

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

Tefazoline (INN) and its salts

Chemical / IUPAC name

2-((5,6,7,8-Tetrahydro-1-naphthyl)methyl)-2-imidazoline

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Key data

CAS
1082-56-0
EC
—
Annex
II
Entry number
237

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

Annex II 238
Nearby record in the same annex

Arecoline

CAS: 63-75-2
EC: 200-565-5
Annex II 241
Nearby record in the same annex

2-Naphthol

CAS: 135-19-3
EC: 205-182-7

What Annex II means for Tefazoline (INN) and its salts

Tefazoline (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. Tefazoline (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 1082-56-0 is the unique numerical identifier assigned to Tefazoline (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 Tefazoline (INN) and its salts

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

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