Is Thiamine HCl safe in cosmetics?
Thiamine HCl has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 3 toxicological study endpoint(s) are available in our database.
Thiamine HCl
Also known as: 3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2-hydroxyethyl)-4-methylthiazolium chloride monohydrochloride, Betabion hydrochloride, Bevitex, Bithiamin, EINECS 200-641-8 (+7 more)
INCI: THIAMINE HCL
Thiamine HCl (CAS 67-03-8) is a cosmetic active ingredient functioning as Antioxidant support; skin energy co-factor; skin conditioning. Reported NOAEL 7.5 mg/kg bw/day in rat (COSMOS_DB); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 67-03-8 →
Auto-generated CPSR Part A draft with source citations
Function
Antioxidant support; skin energy co-factor; skin conditioning
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
No CIR-specific safety assessment for standalone cosmetic use. Thiamine HCl is an essential vitamin with well-established oral safety. FDA-GRAS for food use. Minimal dedicated topical cosmetic research. EU imposes no specific restrictions. Use based on general vitamin safety profile.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Thiamine HCl.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
3 study endpoints found for Thiamine HCl. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 7.5 mg/kg bw/day | oral | rat | Reproductive | COSMOS_DB |
| NOAEL | 50 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 300 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS_DB |
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| NOAEL | =36 mg/kg-day | Rat | oral | subchronic | EFSA |
| NOAEL | =36 mg/kg-day | Rat | oral | subchronic | EFSA |
| LD50 | =13347 mg/kg | Mouse | oral | - | ECHA IUCLID |
| LD50 | =12340 mg/kg | Rat | oral | - | ECHA IUCLID |
| LEL | =9136 mg/kg-day | Mouse | oral | - | ECHA IUCLID |
| LEL | =19670 mg/kg-day | Mouse | oral | - | ECHA IUCLID |
| LEL | =7870 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| LEL | =19400 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | >=1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | >=1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Deodorizer
Flavouring and nutrient
Fragrance
Softener and conditioner
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Thiamine HCl.
Regulatory Flags
antioxidant-support
minimal-cosmetic-data
no-cir-assessment
energy-co-factor
water-soluble
safe-by-analogy
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Thiamine HCl by CAS number or substance name.
Studies
3
Lowest NOAEL
7.5 mg/kg bw/day
Highest NOAEL
300 mg/kg bw/day
COSMOS_DB
Known Synonyms
3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2-hydroxyethyl)-4-methylthiazolium chloride monohydrochloride
Betabion hydrochloride
Bevitex
Bithiamin
EINECS 200-641-8
FEMA No. 3322
NSC 36226
Vitamin B hydrochloride
Vitamin b(sub 1) hydrochloride
UNII-M572600E5P
Thiaminum hydrochloricum
thiamine(2+) dichloride
Chemical Function
Deodorizer
Softener and conditioner
Fragrance
Flavouring and nutrient
Regulatory Lists
Europe; supplements
Europe; food_additive; supplements
Europe
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
inert_ingredient; non_food_use; Pesticides
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
THIAMINE HYDROCHLORIDE
ChEMBL ID
CHEMBL1200941
Max Phase
4
Frequently Asked Questions
Is Thiamine HCl allowed in the EU?
Thiamine HCl EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Thiamine HCl do in cosmetics?
Thiamine HCl functions as: Antioxidant support; skin energy co-factor; skin conditioning. It is classified as a Active Ingredient in our database. CAS number: 67-03-8.
What is the NOAEL for Thiamine HCl?
The NOAEL (No Observed Adverse Effect Level) for Thiamine HCl is 7.5 mg/kg bw/day based on a Reproductive study via oral route in rat. A total of 3 study endpoints are available. Source: COSMOS_DB.
Is Thiamine HCl used outside cosmetics?
Thiamine HCl also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Thiamine HCl compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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