- beauty
- industrial
- pharma
Tetrabenazine
CAS 58-46-8 · 100/100 · High conf.
Also registered as 2 other CAS numbers
2104-79-2 · 39630-28-9
Concern score
100/100Critical concern based on regulatory listings.
High confidence
Tetrabenazine in plain language
Also known as Tetrabenazine (INN) and its salts · (+/-)-Tetrabenazine · Nitoman · Ro 1-9569 · RO-19569 · Xenazine
We don't have a plain-language description for Tetrabenazine yet.
- Critical concern: no hazard classifications on record. It is banned in EU cosmetics.
Why it's flagged
Tetrabenazine (INN) and its salts is prohibited in cosmetic products under Annex II of the EU Cosmetics Regulation (EC) 1223/2009.
RestrictedEU EC — banned
The score describes this ingredient's chemical identity — its hazard profile from published classifications and regulatory status — not the safety of any product it appears in.
Regulation
Restrictions first, then routine listings from published regulatory sources.
- In marketed US drugs
- EU Annex II — prohibited
- EU prohibited in cosmetics
- Found in consumer products
- Industrial
- View source →banned
EUEC
Annex II of EU Cosmetics Regulation (EC) 1223/2009: substances prohibited in cosmetic products.
EUCosIngActiveCosmetics Regulation annex II / ref 139.
- Cosmetics Regulation annex II / ref 139.Source →
USEPAcommercial use observedEPA CPDat observed this chemical in 0 composition records across product categories including unclassified products.
- EPA CPDat observed this chemical in 0 composition records across product categories including unclassified products.Source →
USFDAmarketed drug occurrenceFDA NDC lists this ingredient in 22 active drug products and 24 total products.
- FDA NDC lists this ingredient in 22 active drug products and 24 total products.Source →
USFDAlisted in openFDA substanceopenFDA substance registry classifies this ingredient as chemical.
- openFDA substance registry classifies this ingredient as chemical.Source →
Expert safety opinions
No expert opinion on file for Tetrabenazine. These are the independent scientific bodies that assess ingredients like this one; we show an opinion only when a record we hold cites it.
SCCS
EU Scientific Committee on Consumer Safety
No SCCS opinion on file.
CIR
Cosmetic Ingredient Review (US expert panel)
No CIR safety assessment on file.
Evidence & sources
No graded research studies for Tetrabenazine yet. This record is compiled from the published data sources below — registries and regulatory listings, not study findings.
Where this comes from
- Open →
CosIng
regulatory · updated 2026-09-23
- Open →
EU CosIng Cosmetics Regulation Annexes
regulatory · updated 2010-10-20
- Open →
EPA Chemical and Products Database
exposure · updated November 30, 2008
- Open →
EPA DSSTox Identifiers
chemistry · updated 2025-12-29
- Open →
FDA National Drug Code Directory
regulatory · updated 2028-01-31
- Open →
FDA GSRS UNII
registry · updated 2026-02-26
- Open →
openFDA Substance
registry · updated 2026-05-24
Reference links (2)
accessdata.fda.gov
Suitability
Context-specific fit derived from published classifications and the current ingredient evidence profile.
Fragrance avoidance
No fragrance-linked caution surfaced in the current profile.
This ingredient does not currently read as a fragrance-linked driver in the published evidence and hazard profile.
Where it has been recorded
How often FDA National Drug Code directory has listed Tetrabenazine in a product composition. These are source records, not Greenveil catalog products.
Source records
24