Is Mannitol safe in cosmetics?
Mannitol has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted.
Excellent
Humectant
Mannitol
Also known as: 4-01-00-02841, BRN 1721898, EINECS 200-711-8, NCI-C50362, NSC 407017 (+14 more)
Mannitol (CAS 69-65-8) is a cosmetic humectant functioning as Anti-caking agent; Binder; Deodorizer; Flavouring and nutrient; Fragrance;. EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical and food safety data.
View industrial chemical safety profile for CAS 69-65-8 →
Auto-generated CPSR Part A draft with source citations
Function
Anti-caking agent; Binder; Deodorizer; Flavouring and nutrient; Fragrance; Humectant; Lubricating agent; Processing aids not otherwise specified; Softener and conditioner; Solvent
Safety Rating
EXCELLENT
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
FDA GRAS for oral use; cosmetic use unrestricted. CIR-reviewed polyol. Gentle humectant suited for sensitive-skin formulations.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Mannitol.
Calculate MoS for your specific formulation with the MoS Calculator.
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 |
|---|---|---|---|---|---|
| NOEL | =2000 mg/kg-day | Mouse | oral | short-term | ECOTOX |
| NOEL | =2000 mg/kg-day | Rat | oral | short-term | ECOTOX |
| NOEL | =2000 mg/kg-day | Rat | oral | short-term | ECOTOX |
| NOEL | =2000 mg/kg-day | Rat | oral | acute | ECOTOX |
| LEL | =1250 mg/kg-day | Rat | oral | chronic | ToxRefDB |
| LEL | =2500 mg/kg-day | Rat | oral | chronic | ToxRefDB |
| LEL | =7500 mg/kg-day | Mouse | oral | chronic | ToxRefDB |
| LEL | =3750 mg/kg-day | Mouse | oral | chronic | ToxRefDB |
| LEL | >2500 mg/kg-day | Rat | oral | subchronic | ToxRefDB |
| LEL | =2500 mg/kg-day | Rat | oral | subchronic | ToxRefDB |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Roberts Skin Permeation (Mendeley 2022)
MW: 182.2
Log Kow: -4.67
Log Kp: -4.00436480540245
Log Jmax: -6.749092300299144
Source: Roberts_Cheruvu_Mendeley_2022
Additional Ingredient Properties
7 property records from structured ingredient metadata.
anti_aging
{"anti_aging_claim": "hydration-plumping, prebiotic", "mechanism_of_action": "Microbiome modulation, barrier support", "target_skin_layer": "stratum corneum, epidermis", "collagen_stimulation": "No", "elastin_protection": "No", "wrinkle_reduction_pct": "5-10", "clinical_study_duration_weeks": "8", "sample_size": "30", "double_blind": "No", "placebo_controlled": "Yes", "published_journal": "Microbi…
anti_pollution
{"cas_number": "69-65-8", "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": "69-65-8", "ingredient_class": "moisturizer_baby", "pediatric_safety_rating": "excellent", "minimum_age_months": "0", "neonatal_safe": "yes", "premature_infant_safe": "yes", "skin_barrier_maturity_consideration": "Sugar alcohol, GRAS", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern": "Humectant penetr…
humectant
{"cas_number": "69-65-8", "ingredient_class": "humectant/polyol/sugar_derivative", "molecular_weight_Da": "182.17", "chemical_type": "polyol", "water_binding_mechanism": "hydrogen_bonding/hygroscopic", "water_holding_capacity_g_per_g": "0.5-0.7", "hygroscopicity_at_50_RH": "good", "hygroscopicity_at_80_RH": "excellent", "NMF_component": "no", "NMF_percentage_natural": "0", "TEWL_reduction_pct": "1…
ph_stability
{"optimal_ph_min": "3.0", "optimal_ph_max": "10.0", "stable_ph_min": "3.0", "stable_ph_max": "11.0", "ph_dependent_function": "Sugar alcohol humectant", "formulation_note": "Very stable", "source": "Formulation literature"}
solubility_hlb
{"water_soluble": "yes", "oil_soluble": "no", "soluble_in": "water, glycerin", "insoluble_in": "oils, ethanol, silicones", "log_p": "-3.4", "melting_point_c": "166-168", "appearance": "white powder", "source": "Roquette"}
supply_chain
{"primary_producing_countries": "China, France, USA", "secondary_producing_countries": "Germany, Italy, India", "raw_material_origin": "plant", "agricultural_crop_or_wild_harvested": "seaweed_extraction_fermentation", "cultivation_climate_required": "kelp_fermentation", "harvest_season": "continuous", "annual_global_production_tonnes": "180000", "market_share_top_producer_pct": "68", "supply_chain…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-caking agent
Binder
Deodorizer
Flavouring and nutrient
Fragrance
Humectant
Lubricating agent
Processing aids not otherwise specified
Softener and conditioner
Solvent
Regulatory List Membership (2)
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Mannitol.
Regulatory Flags
polyol-humectant
6-oh-groups
gentle-sensitive-skin
fda-gras
sugar-alcohol
ifra_fragrance
fda_food_additive
jecfa_safe
Known Synonyms
4-01-00-02841
BRN 1721898
EINECS 200-711-8
NCI-C50362
NSC 407017
Mannitol 10%
Mannitol 10% in plastic container
Mannitol 10% w/ dextrose 5% in distilled water
Mannitol 15%
Mannitol 15% in plastic container
Mannitol 15% w/ dextrose 5% in sodium chloride 0.45%
Mannitol 20%
Mannitol 20% in plastic container
Mannitol 25%
Mannitol 5%
Mannitol 5% in plastic container
Mannitol 5% w/ dextrose 5% in sodium chloride 0.12%
Osmitrol 10% in water
Osmitrol 10% in water in plastic container
Chemical Function
Humectant
Deodorizer
Softener and conditioner
Binder
Fragrance
Flavouring and nutrient
Processing aids not otherwise specified
Solvent
Anti-caking agent
Lubricating agent
Regulatory Lists
IFRA Transparency
inert_ingredient; non_food_use; Pesticides
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
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
MANNITOL
ChEMBL ID
CHEMBL689
Max Phase
4
Adverse Event Associations
1561
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Mannitol
E Number
E421
ADI
10 mg/kg bw
Food Category
sweetener
Frequently Asked Questions
Is Mannitol allowed in the EU?
Mannitol EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Mannitol do in cosmetics?
Mannitol functions as: Anti-caking agent; Binder; Deodorizer; Flavouring and nutrient; Fragrance; Humectant; Lubricating agent; Processing aids not otherwise specified; Softener and conditioner; Solvent. It is classified as a Humectant in our database. CAS number: 69-65-8.
Is Mannitol used outside cosmetics?
Mannitol 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 Mannitol 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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