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Annex II Entry 199 15/10/2010

Hydrastine, hydrastinine and their salts

Hydrastine, hydrastinine and their 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: 199

Chemical identity and properties

PubChem 2D chemical structure for CAS 118-08-1
CAS 118-08-1PubChem CID 197835

(-)-Hydrastine

Hydrastine is a natural product found in Hydrastis canadensis. It has a role as a metabolite. — ChEBI

IUPAC name
(3S)-6,7-dimethoxy-3-[(5R)-6-methyl-7,8-dihydro-5H-[1,3]dioxolo[4,5-g]isoquinolin-5-yl]-3H-2-benzofuran-1-one
Molecular formula
C21H21NO6
Molecular weight
383.4 g/mol
Exact mass
383.13688739 Da
XLogP3
2.7
Topological polar surface area
66.5 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
7
Covalent units
1
Defined stereocentres
2

Also known as

HYDRASTINENSC-7574308890V3217X6,7-Dimethoxy-3-(5,6,7,8-tetrahydro-6-methyl-1,3-dioxolo(4,5-g)isoquinoline-5-yl)-1(3H)-isobenzo furanIsocoryne(3S)-6,7-dimethoxy-3-((5R)-6-methyl-7,8-dihydro-5H-(1,3)dioxolo(4,5-g)isoquinolin-5-yl)-3H-2-benzofuran-1-oneRefChem:39364204-233-0
16 more reported names
beta-Hydrastine(-)-beta-Hydrastine(+/-)-beta-HydrastineHYDRASTINE (1R, 9S)(+/-)-b-Hydrastine(3S)-6,7-Dimethoxy-3-[(5R)-5,6,7,8-tetrahydro-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl]-1(3H)-isobenzofuranoneCHEBI:69919l-Hydrastine(3S)-6,7-dimethoxy-3-[(5R)-6-methyl-7,8-dihydro-5H-[1,3]dioxolo[4,5-g]isoquinolin-5-yl]-3H-isobenzofuran-1-one3-((5R)-6-methyl(5,6,7,8-tetrahydro-2H-1,3-dioxoleno[4,5-g]isoquinolin-5-yl))( 3S)-6,7-dimethoxy-3-hydroisobenzofuran-1-oneHydrastine [USP]Phthalide, 6,7-dimethoxy-3-(5,6,7,8-tetrahydro-6-methyl-1,3-dioxolo(4,5-g)isoquinolin-5-yl)-EINECS 204-233-0(1R,9S)-beta-HydrastineBRN 0098575Hydrastin
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Evidence from additional scientific databases

NIH PubChem PUG-View
Exact identifier match197835

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

  • Signal: Warning Source: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: H302 (100%): Harmful if swallowed [Warning Acute toxicity, oral]; H312 (97.5%): Harmful in contact with skin [Warning Acute toxicity, dermal]; H332 (97.5%): Harmful if inhaled [Warning Acute toxicity, inhalation] Source: European Chemicals Agency (ECHA)
  • Precautionary Statement Codes: P261, P264, P270, P271, P280, P301+P317, P302+P352, P304+P340, P317, P321, P330, P362+P364, and P501 (click each P-code to see the statement) Source: European Chemicals Agency (ECHA)
  • ECHA C&L Notifications Summary: Aggregated GHS information provided per 40 reports by companies from 2 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.; Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website. Source: European Chemicals Agency (ECHA)

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.

PubChem 2D chemical structure for CAS 6592-85-4
CAS 6592-85-4PubChem CID 3638

Hydrastinine

Hydrastinine is an organic molecular entity. — ChEBI

IUPAC name
6-methyl-7,8-dihydro-5H-[1,3]dioxolo[4,5-g]isoquinolin-5-ol
Molecular formula
C11H13NO3
Molecular weight
207.23 g/mol
Exact mass
207.08954328 Da
XLogP3
1.1
Topological polar surface area
41.9 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
4
Covalent units
1
Defined stereocentres
0

Also known as

V1I0L48X6ENSC-7558921,3-Dioxolo(4,5-g)isoquinolin-5-ol, 5,6,7,8-tetrahyro-6-methyl-6-methyl-7,8-dihydro-5H-(1,3)dioxolo(4,5-g)isoquinolin-5-olRefChem:414949229-533-9Hydraztinine5,6,7,8-tetrahydro-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-ol
16 more reported names
5,6,7,8-Tetrahydro-6-methyl-1,3-dioxolo(4,5-g)isoquinolin-5-ol1,3-Dioxolo[4,5-g]isoquinolin-5-ol, 5,6,7,8-tetrahydro-6-methyl-1,3-DIOXOLO(4,5-g)ISOQUINOLIN-5-OL, 5,6,7,8-TETRAHYDRO-6-METHYL-EINECS 229-533-9BRN 0014208UNII-V1I0L48X6EHydrastininSpectrum_0003776-methyl-2H,5H,6H,7H,8H-[1,3]dioxolo[4,5-g]isoquinolin-5-olPrestwick0_000195Prestwick1_000195Prestwick2_000195Spectrum2_000742Spectrum3_001149Spectrum4_001762Spectrum5_000343
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

Hydrastine, hydrastinine and their salts

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Key data

CAS
118-08-1 / 6592-85-4
EC
204-233-0 / 229-533-9
Annex
II
Entry number
199

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

What Annex II means for Hydrastine, hydrastinine and their salts

Hydrastine, hydrastinine and their 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. Hydrastine, hydrastinine and their 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 118-08-1 / 6592-85-4 is the unique numerical identifier assigned to Hydrastine, hydrastinine and their 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 Hydrastine, hydrastinine and their salts

This page summarizes one Annex II record for Hydrastine, hydrastinine and their 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 Hydrastine, hydrastinine and their salts, but confirm any final regulatory decision against the current official annex wording and source files.

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