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Annex II Entry 365 20/10/2010

Aristolochic acid and its salts; Aristolochia spp. and their preparations

Aristolochic acid and its salts; Aristolochia spp. and their preparations 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: 365

Chemical identity and properties

PubChem 2D chemical structure for CAS 15918-62-4
CAS 15918-62-4PubChem CID 167493

Aristolochic Acid Iv

Aristolochic acid IV has been reported in Aristolochia esperanzae, Aristolochia kankauensis, and other organisms with data available. — LOTUS - the natural products occurrence database

IUPAC name
8,10-dimethoxy-6-nitronaphtho[2,1-g][1,3]benzodioxole-5-carboxylic acid
Molecular formula
C18H13NO8
Molecular weight
371.3 g/mol
Exact mass
371.06411637 Da
XLogP3
3.5
Topological polar surface area
120.0 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
8
Covalent units
1
Defined stereocentres
0

Also known as

O-Methylaristolochic acid D6-Methoxyaristolochic acid DBRN 1332635Aristolochic acid IV(sub a) methyl ether8,10-Dimethoxy-6-nitrophenanthro(3,4-d)-1,3-dioxole-5-carboxylic acid2,3-Methylenedioxy-5,7-dimethoxy-10-nitrophenanthroic acidPhenanthro(3,4-d)-1,3-dioxole-5-carboxylic acid, 8,10-dimethoxy-6-nitro-8,10-Dimethoxy-6-nitrophenanthro[3,4-d]-1,3-dioxole-5-carboxylic acid
8 more reported names
Phenanthro[3,4-d]-1,3-dioxole-5-carboxylic acid, 8,10-dimethoxy-6-nitro-Aristolochate IV8,10-dimethoxy-6-nitronaphtho(2,1-g)(1,3)benzodioxole-5-carboxylic acidRefChem:1140538,10-dimethoxy-6-nitrophenanthro[3,4-d][1,3]dioxole-5-carboxylic acidL28X6WY7768,10-dimethoxy-6-nitro-2H-phenanthro[3,4-d][1,3]dioxole-5-carboxylic acid6-Nitro-8,10-dimethoxy-phenanthro[3,4-d]-1,3-dioxol-5-carbonsaure
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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 313-67-7
CAS 313-67-7PubChem CID 2236

Aristolochic Acid

Aristolochic acid A is an aristolochic acid that is phenanthrene-1-carboxylic acid that is substituted by a methylenedioxy group at the 3,4 positions, by a methoxy group at position 8, and by a nitro group at position 10. It is the most abundant of the aristolochic acids and is found in almost all Aristolochia (birthworts or pipevines) species. It has been tried in a number of treatments for inflammatory disorders, mainly in Chinese and folk medicine. However, there is concern over their use as aristolochic acid is both carcinogenic and nephrotoxic. It has a role as a metabolite, a mutagen, a carcinogenic agent and a nephrotoxin. It is a member of aristolochic acids, a monocarboxylic acid, an aromatic ether, a C-nitro compound, an organic heterotetracyclic compound and a cyclic acetal. — ChEBI

IUPAC name
8-methoxy-6-nitronaphtho[2,1-g][1,3]benzodioxole-5-carboxylic acid
Molecular formula
C17H11NO7
Molecular weight
341.27 g/mol
Exact mass
341.05355169 Da
XLogP3
3.6
Topological polar surface area
111.0 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
7
Covalent units
1
Defined stereocentres
0

Also known as

Aristolochic acid AAristolochic acid IAristolochinTardolytAristolochic acid-IARISTOLOCHINETR 1736NSC-50413
16 more reported names
8-Methoxy-6-nitrophenanthro[3,4-d][1,3]dioxole-5-carboxylic acid8-Methoxy-3,4-methylenedioxy-10-nitrophenanthrene-1-carboxylic acid3,4-Methylenedioxy-8-methoxy-10-nitro-1-phenanthrenecarboxylic acidCHEBI:28258-Methoxy-6-nitrophenanthol (3,4-d) 1,3-dioxole-5-carboxylic acidNSC-11926TR-1736Phenanthro(3,4-d)-1,3-dioxole-5-carboxylic acid, 8-methoxy-6-nitro-Phenanthro[3,4-d]-1,3-dioxole-5-carboxylic acid, 8-methoxy-6-nitro-8-methoxy-6-nitrophenanthro(3,4-d)-1,3-dioxole-5-carboxylic acid8-methoxy-6-nitronaphtho(2,1-g)(1,3)benzodioxole-5-carboxylic acid8-methoxy-6-nitrophenanthro(3,4-d)(1,3)dioxole-5-carboxylic acidRefChem:28223206-238-36-methoxy-9-nitro-14,16-dioxatetracyclo(8.7.0.02,7.013,17)heptadeca-1,3,5,7,9,11,13(17)-heptaene-11-carboxylic acidBirthwort
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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.

PubChem 2D chemical structure for CAS 475-80-9
CAS 475-80-9PubChem CID 108168

Aristolochic Acid Ii

Aristolochic acid B is an aristolochic acid that is phenanthrene-1-carboxylic acid substituted by a methylenedioxy group at the 3,4 positions and by a nitro group at position 10. It has a role as a metabolite, a mutagen, a carcinogenic agent and a nephrotoxin. It is a member of aristolochic acids, a monocarboxylic acid, an aromatic ether, a C-nitro compound, an organic heterotetracyclic compound and a cyclic acetal. — ChEBI

IUPAC name
6-nitronaphtho[2,1-g][1,3]benzodioxole-5-carboxylic acid
Molecular formula
C16H9NO6
Molecular weight
311.24 g/mol
Exact mass
311.04298701 Da
XLogP3
3.6
Topological polar surface area
102.0 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
6
Covalent units
1
Defined stereocentres
0

Also known as

Aristolochic acid BBB72D5PU2YPhenanthro(3,4-d)-1,3-dioxole-5-carboxylic acid, 6-nitro-6-nitronaphtho(2,1-g)(1,3)benzodioxole-5-carboxylic acidRefChem:283606-nitrophenanthro(3,4-d)-3-dioxole-5-carboxylic acid207-499-6CCRIS 6497
16 more reported names
6-nitrophenanthro[3,4-d][1,3]dioxole-5-carboxylic acidAristolochicacidBEINECS 207-499-66-nitrophenanthro[3,4-d]-1,3-dioxole-5-carboxylic acid6-nitro-2H-phenanthro[3,4-d][1,3]dioxole-5-carboxylic acidCHEBI:194149HY-N05116-Nitrophenanthro(3,4-d)-1,3-dioxole-5-carboxylic acid6-nitronaphtho[1,2-e][1,3]benzodioxole-5-carboxylic acid6-nitro-phenanthro-[3,4-d]-1,3-dioxole-5-carboxylic acidUNII-BB72D5PU2YBRN 0329754MEEXETVZNQYRSP-UHFFFAOYSA-N6-Nitro-phenanthro[3,4-d]-1,3-dioxole-5-carboxylic Acid; Aristolochic Acid II;3,4-(Methylenedioxy)-10-nitrophenanthrene-1-carboxylic Acid;Aristolochic acid _Epitope ID:2157313
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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

Aristolochic acid and its salts; Aristolochia spp. and their preparations

Regulatory information

Regulation

(EC) 2009/1223

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SCCS opinions

Key data

CAS
475-80-9 / 313-67-7 / 15918-62-4
EC
202-499-6 / 206-238-3 / -
Annex
II
Entry number
365

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

Annex II 366
Nearby record in the same annex

Chloroform

CAS: 67-66-3
EC: 200-663-8

What Annex II means for Aristolochic acid and its salts; Aristolochia spp. and their preparations

Aristolochic acid and its salts; Aristolochia spp. and their preparations 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. Aristolochic acid and its salts; Aristolochia spp. and their preparations 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 475-80-9 / 313-67-7 / 15918-62-4 is the unique numerical identifier assigned to Aristolochic acid and its salts; Aristolochia spp. and their preparations 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 Aristolochic acid and its salts; Aristolochia spp. and their preparations

This page summarizes one Annex II record for Aristolochic acid and its salts; Aristolochia spp. and their preparations 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 Aristolochic acid and its salts; Aristolochia spp. and their preparations, but confirm any final regulatory decision against the current official annex wording and source files.

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