Is Pro-Retinol safe in cosmetics?
Pro-Retinol has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted. 7 toxicological study endpoint(s) are available in our database.
Pro-Retinol
Also known as: All-trans-retinyl palmitate, Vitamin A palmitate, BRN 1917366, EINECS 201-228-5, Vitamin A solubilized (+14 more)
INCI: RETINYL PALMITATE
Pro-Retinol (CAS 79-81-2) is a cosmetic active ingredient functioning as Skin conditioning; vitamin A ester. Reported NOAEL 1.2 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 79-81-2 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Pro-Retinol is classified GHS Danger (H315, H360, H361, H413) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Skin conditioning; vitamin A ester
Safety Rating
MODERATE
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
No FDA restriction on retinyl propionate or HPR in cosmetics. Neither has OTC drug status. CIR assessed within retinyl ester class review. Brands marketing Pro-Retinol may use retinyl propionate, HPR, or retinyl beta-glucoside -- verify INCI on label. PM use recommended; not recommended during pregnancy.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Pro-Retinol.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
7 study endpoints found for Pro-Retinol. 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 | ToxValDB_ECHA_IUCLID |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Pro-Retinol, 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/1378/10
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 IUCLID |
| LD50 | =7910 mg/kg | Rat | oral | - | ECHA IUCLID |
| LOAEL | =10.368 mg/kg-day | Rat | oral | subchronic | ECHA IUCLID |
| LOAEL | =10.752 mg/kg-day | Rat | oral | subchronic | ECHA IUCLID |
| NOAEL | =2.592 mg/kg-day | Rat | oral | subchronic | ECHA IUCLID |
| NOAEL | =2.688 mg/kg-day | Rat | oral | subchronic | ECHA IUCLID |
| NOEL | <2.592 mg/kg-day | Rat | oral | subchronic | ECHA IUCLID |
| 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/VCRP |
| Body Lotion | 0.1–1 | 2 | CIR/VCRP |
Additional Ingredient Properties
10 property records from structured ingredient metadata.
acne
{"cas_number": "79-81-2", "anti_acne_mechanism": "keratolytic/comedolytic", "comedogenicity_rating_0_to_5": "2", "acne_type_efficacy": "inflammatory", "sebum_reduction_pct_clinical": "0-10", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentration_pct": "No limit", "japan_quasi_drug_anti_acne": "No", "korea_functional_cosmetic_acne": "No", "eu_cosmetic_restric…
anti_aging
{"anti_aging_claim": "anti-wrinkle, hydration-plumping, antioxidant-protection", "mechanism_of_action": "Ester form converted to retinol then retinoic acid, gentler conversion pathway", "target_skin_layer": "epidermis", "collagen_stimulation": "Mild", "elastin_protection": "Mild", "wrinkle_reduction_pct": "5-15", "clinical_study_duration_weeks": "24", "sample_size": "97", "double_blind": "Yes", "p…
anti_pollution
{"cas_number": "79-81-2", "ingredient_class": "other", "primary_mechanism": "barrier_reinforcement", "pollution_types_targeted": "PM2_5", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modulation": "no", "NF_kB_inhibition…
baby_pediatric
{"cas_number": "79-81-2", "ingredient_class": "other", "pediatric_safety_rating": "avoid", "minimum_age_months": "24", "neonatal_safe": "no", "premature_infant_safe": "insufficient_data", "skin_barrier_maturity_consideration": "Vitamin A - caution pediatric", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern": "Appropr…
comedogenicity_detail
{"comedogenicity_rating": "1", "irritancy_rating": "2", "skin_type_suitability": "combination,normal,mature", "acne_safe": "caution", "source": "Stable retinoid"}
concentration
{"min_concentration_pct": "0.1", "max_concentration_pct": "0.5", "typical_concentration_pct": "0.25", "product_type": "Sunscreen", "function_at_concentration": "Anti-aging adjunct", "source": "CIR Safety Assessment"}
cost_pricing
{"cost_tier": "mid-range", "estimated_cost_per_kg_usd_low": "45", "estimated_cost_per_kg_usd_high": "85", "natural_premium_markup_pct": "0", "organic_certified_premium_pct": "0", "supply_chain_volatility": "low", "primary_source_region": "Global (synthetic)", "bulk_discount_threshold_kg": "25", "seasonal_price_variation": "low", "commodity_or_specialty": "specialty", "substitute_ingredients": "Ret…
dermal_absorption
{"molecular_weight_da": "524.9", "log_p_value": "13.5", "skin_penetration_level": "stratum-corneum", "penetration_depth": "stratum corneum", "absorption_pct": "1-3", "systemic_absorption": "minimal", "penetration_enhancer": "no", "occlusion_effect": "no", "vehicle_dependent": "yes", "skin_barrier_effect": "neutral", "bioavailability_topical_pct": "0.5-2", "safety_margin_factor": "variable", "sourc…
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)
Expert Verdict
Expert safety assessment and concern-level summary for Pro-Retinol.
Regulatory Flags
enhanced-skin-absorption
developmental-reproductive-toxicity
pregnancy-warning
use-restrictions
photodegradation-free-radicals
vitamin-a-derivative
ewg-restricted
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Pro-Retinol 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
ToxValDB_ECHA_IUCLID
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 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
Frequently Asked Questions
Is Pro-Retinol allowed in the EU?
Pro-Retinol EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Pro-Retinol do in cosmetics?
Pro-Retinol functions as: Skin conditioning; vitamin A ester. It is classified as a Active Ingredient in our database. CAS number: 79-81-2.
What is the NOAEL for Pro-Retinol?
The NOAEL (No Observed Adverse Effect Level) for Pro-Retinol 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 Pro-Retinol used outside cosmetics?
Pro-Retinol 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.
Does Pro-Retinol have different safety status in cosmetics vs industrial chemicals?
Pro-Retinol is classified GHS Danger (H315, H360, H361, H413) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check Pro-Retinol compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
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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