Butanilicaine (INN) and its salts
Butanilicaine (INN) and its salts is listed in Annex II as a prohibited substance for cosmetic products placed on the EU market.
Chemical identity and properties
Butanilicaine
Butanilicaine is an amino acid amide amide in which N-butylglycine and 2-chloro-6-methylaniline have combined to form the amide bond; used as a local anaesthetic (amide caine). It has a role as a local anaesthetic. It is an amino acid amide and a member of monochlorobenzenes. — ChEBI
- IUPAC name
- 2-(butylamino)-N-(2-chloro-6-methylphenyl)acetamide
- Molecular formula
- C13H19ClN2O
- Molecular weight
- 254.75 g/mol
- Exact mass
- 254.1185909 Da
- XLogP3
- 2.1
- Topological polar surface area
- 41.1 Ų
- Hydrogen-bond donors
- 2
- Hydrogen-bond acceptors
- 2
- Covalent units
- 1
- Defined stereocentres
- 0
Also known as
15 more reported names
External database identifiers
- ChEBI:CHEBI:55518
- ChEMBL:CHEMBL2104238
- EPA DTXSID:DTXSID90191279
- PubMed:18065672
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
Butanilicaine (INN) and its salts
Chemical / IUPAC name
2-Butylamino-6'-chloro-o-acetotoluidide
Regulatory information
Key data
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What Annex II means for Butanilicaine (INN) and its salts
Butanilicaine (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
Source note for Annex II record Butanilicaine (INN) and its salts
This page summarizes one Annex II record for Butanilicaine (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 Butanilicaine (INN) and its salts, but confirm any final regulatory decision against the current official annex wording and source files.
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