Is Retinyl Palmitate safe in cosmetics?
Retinyl Palmitate has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted. 7 toxicological study endpoint(s) are available in our database.
Retinyl Palmitate
Also known as: All-trans-retinyl palmitate, Vitamin A palmitate, BRN 1917366, EINECS 201-228-5, Vitamin A solubilized (+14 more)
INCI: RETINYL PALMITATE
Retinyl Palmitate (CAS 79-81-2) is a cosmetic active ingredient functioning as skin-conditioning, antioxidant. Reported NOAEL 1.2 mg/kg bw/day in rat (COSMOS DB); EU Regulation 1223/2009 status: restricted, max 0.3%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical and food safety data.
Function
skin-conditioning, antioxidant
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.3%
US US Status
permitted
US Notes
Safe at use levels; least potent retinoid; primarily antioxidant role
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Retinyl Palmitate.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
7 study endpoints found for Retinyl Palmitate. 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 | 1.2 mg/kg bw/day | oral | rat | Chronic | COSMOS DB |
| NOAEL | 1.4 mg/kg bw/day | oral | rat | Special Toxicology Study | COSMOS DB |
| NOAEL | 4.09999990463 mg/kg bw/day | oral | primate | Developmental | COSMOS DB |
| NOAEL | 5.5 mg/kg bw/day | oral | rat | Neurotoxicity | COSMOS DB |
| NOAEL | 14 mg/kg bw/day | oral | dog | Chronic | COSMOS DB |
| NOAEL | 24 mg/kg bw/day | oral | rat | Developmental | COSMOS DB |
| NOAEL | =2.688 mg/kg bw/day | oral | Rat | subchronic | ECHA |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Retinyl Palmitate, relevant to systemic exposure and MoS calculations.
Absorption %
1-3%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum
Molecular Weight
524.9 Da
Log P
13.5
Systemic Absorption
minimal
Topical Bioavailability
0.5-2%
Safety Margin Factor
variable
Vehicle Dependent
Yes — absorption varies by formulation
Source: SCCS Opinion
EPA ToxValDB — Toxicity Values
9 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >2000 mg/kg | Rat | oral | - | ECHA |
| LD50 | =7910 mg/kg | Rat | oral | - | ECHA |
| LOAEL | =10.368 mg/kg-day | Rat | oral | subchronic | ECHA |
| LOAEL | =10.752 mg/kg-day | Rat | oral | subchronic | ECHA |
| NOAEL | =2.592 mg/kg-day | Rat | oral | subchronic | ECHA |
| NOAEL | =2.688 mg/kg-day | Rat | oral | subchronic | ECHA |
| NOEL | <2.592 mg/kg-day | Rat | oral | subchronic | ECHA |
| LD50 | =6060 mg/kg | Mouse | oral | - | ChemIDplus |
| LD50 | =7910 mg/kg | Rat | oral | - | ChemIDplus |
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Cosmetic-Specific Mechanism
Category: other
Receptor targets: RAR, RXR
LOEC: 100 nM
EU status: restricted (max 0.3% face leave-on; EU 2024/996)
agonist (RAR/RXR via conversion to retinol)
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; GROUP
SVHC Candidate
No
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (5)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | restricted | 0.3 | Face and body leave-on products |
| AU | restricted | 0.3 | anti-aging products |
| SA | restricted | 0.3 | Leave-on and rinse-off products |
| AE | restricted | 0.3 | Leave-on and rinse-off products |
| UK | restricted | - | - |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Face Cream | 0.1–1 | 2 | CIR Safety Assessment |
| Body Lotion | 0.1–1 | 2 | CIR Safety Assessment |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Antioxidant
Dye
Flavouring and nutrient
Pharmaceutical
Softener and conditioner
Regulatory List Membership (2)
EU Regulated in Personal Care
FDA Substances Added to Food (EAFUS)
Editorial summary
Preliminary editorial summary for Retinyl Palmitate — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
pregnancy-caution
eu-restricted
low-potency
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Retinyl Palmitate by CAS number or substance name.
Studies
7
Lowest NOAEL
1.2 mg/kg bw/day
Highest NOAEL
24 mg/kg bw/day
COSMOS DB
ECHA
Known Synonyms
All-trans-retinyl palmitate
Vitamin A palmitate
BRN 1917366
EINECS 201-228-5
Vitamin A solubilized
UNII-1D1K0N0VVC
Ester found in fish liver oils
Lutavit A 500 Plus
Myvak
Myvax
Optovit A
Optovit-A
Retinyl hexadecanoate
Retinyl hexadecanoic acid
Retinyl palmitic acid
[(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)nona-2,4,6,8-tetraenyl] hexadecanoate
all-trans-retinyl hexadecanoate
hexadecanoic acid [(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)nona-2,4,6,8-tetraenyl] ester
palmitic acid [(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)nona-2,4,6,8-tetraenyl] ester
Chemical Function
Softener and conditioner
Pharmaceutical
Regulatory Lists
Europe; supplements
Europe; food_additive; supplements
Europe; Personal care
Europe; Personal care
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
VITAMIN A PALMITATE
ChEMBL ID
CHEMBL1675
Max Phase
4
Adverse Event Associations
1665
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Retinyl palmitate
ADI
0.8 mg/kg bw
Food Category
preservative
Frequently Asked Questions
Is Retinyl Palmitate allowed in the EU?
Retinyl Palmitate EU regulatory status: restricted. Maximum allowed concentration: 0.3%. This is based on EU Regulation 1223/2009 and its amendments.
What does Retinyl Palmitate do in cosmetics?
Retinyl Palmitate functions as: skin-conditioning, antioxidant. It is classified as a Active Ingredient in our database. CAS number: 79-81-2.
What is the NOAEL for Retinyl Palmitate?
The NOAEL (No Observed Adverse Effect Level) for Retinyl Palmitate is 1.2 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 7 study endpoints are available. Source: COSMOS DB.
Is Retinyl Palmitate used outside cosmetics?
Retinyl Palmitate also appears in pharmaceutical and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Retinyl Palmitate compliance across multiple jurisdictions:
Ingredient Decoder
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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Chemical family
Fragrance (perfuming)
ACRYLAMIDE
MODERATE
Chemical family
Not Reported
ACRYLIC ACID
GOOD
Chemical family
Nail Conditioning
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