Moderate Emollient Dermal Penetration

Lanolin

Also known as: Caswell No. 518, EINECS 232-348-6, EPA Pesticide Chemical Code 031601, Fats and Glyceridic oils, lanoline, Wollfett (+15 more)

INCI: LANOLIN

Lanolin (CAS 8006-54-0) is a cosmetic emollient functioning as Complex mixture of esters, diesters, and hydroxy esters derived from sheep wool. 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 8006-54-0 →

Auto-generated CPSR Part A draft with source citations
Function
Complex mixture of esters, diesters, and hydroxy esters derived from sheep wool wax. Highly effective occlusive emollient mimicking skin sebum lipid complexity. Modern ultra-refined pharmaceutical grades achieve allergen levels below detectable thresholds. Functions as emollient, occlusive, and skin-conditioning agent.
Safety Rating
MODERATE

Chemistry & Identifiers

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes FDA-approved OTC active ingredient: skin protectant at 12.5-50% (21 CFR 347.10(k)); anorectal products (21 CFR 346.14); ophthalmic products (21 CFR 349.14). Inactive ingredient: ophthalmic ointments up to 10% (Lanolin Alcohol), topical creams/lotions/ointments up to 6% (Lanolin Alcohol). Permitted food additive in chewing gum base (21 CFR 172.615). CIR 2024: safe as used.

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Lanolin.

Calculate MoS for your specific formulation with the MoS Calculator.

Dermal Penetration Profile

Skin absorption and penetration characteristics of Lanolin, relevant to systemic exposure and MoS calculations.

Absorption %
2-6%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum
Molecular Weight
Variable Da
Log P
n/a
Systemic Absorption
minimal
Topical Bioavailability
1-4%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation

Source: CIR

HRIPT Human Patch Test Studies

1 human repeat insult patch test aggregated from dermatological literature.

Test Type N Sensitized Dose µg/cm² NESIL µg/cm² Potency
HMT - 0 15517.24 - -

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 (1)
Jurisdiction Status Max % Product Type
GCC halal_restricted - All cosmetics

Typical Use Concentrations

Reported concentration ranges per product category from SCCS/CIR/industry sources.

Product Category Typical Range Max Reported Source
Face Cream 1–5 20 CIR/VCRP
Lip Balm 5–20 40 CIR/VCRP

Additional Ingredient Properties

10 property records from structured ingredient metadata.

anti_pollution
{"cas_number": "8006-54-0", "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_inhibiti…
comedogenicity_detail
{"comedogenicity_rating": "3", "irritancy_rating": "2", "skin_type_suitability": "dry", "acne_safe": "no", "source": "Fulton 1989"}
concentration
{"min_concentration_pct": "2.0", "max_concentration_pct": "20.0", "typical_concentration_pct": "10.0", "product_type": "Nipple Cream", "function_at_concentration": "Healing, protection", "source": "CIR Safety Assessment"}
dermal_absorption
{"molecular_weight_da": "Variable", "skin_penetration_level": "stratum-corneum", "penetration_depth": "stratum corneum", "absorption_pct": "2-6", "systemic_absorption": "minimal", "penetration_enhancer": "yes", "occlusion_effect": "yes", "vehicle_dependent": "yes", "skin_barrier_effect": "strengthens", "bioavailability_topical_pct": "1-4", "safety_margin_factor": "low", "source": "CIR"}
ecotoxicity
{"biodegradable": "yes", "biodegradation_days": "60-120", "bioaccumulative": "no", "aquatic_toxicity_level": "low", "coral_reef_safe": "yes", "marine_toxicity": "very low toxicity", "freshwater_toxicity": "minimal impact", "endocrine_disruptor": "no", "persistent_organic_pollutant": "no", "microplastic": "no", "nano_particle": "no", "hawaii_banned": "no", "eu_restricted_environmental": "no", "palm…
emulsion_hlb
{"hlb_required_as_emulsifier": "no", "hlb_required_of_oil_phase": "8-12", "co_emulsifier_pairs": "polysorbate_80,ceteth_20", "optimal_oil_phase_pct": "15-40", "optimal_water_phase_pct": "60-85", "droplet_size_range_um": "8-60", "creaming_resistance": "moderate", "coalescence_resistance": "excellent", "ostwald_ripening_resistance": "good", "freeze_thaw_stability": "moderate", "rheology_modifier_typ…
hair_care
{"hair_function": "moisturizing", "hair_type_suitability": "coarse", "curl_pattern_suitability": "all", "porosity_suitability": "low/medium", "protein_sensitivity": "neutral", "moisture_protein_balance": "yes", "cg_method_approved": "not-a-silicone", "silicone_type": "not-a-sulfate", "sulfate_type": "no", "drying_alcohol": "no", "fatty_alcohol": "no", "heat_protectant": "yes", "color_safe": "neutr…
lipid
{"cas_number": "8006-54-0", "lipid_class": "lanolin_derivative", "botanical_source": "Ovis aries (sheep wool)", "plant_part": "secretion", "extraction_method": "refined", "fatty_acid_profile_main_pct": "complex wax esters - lanolic, carnaubic acids", "omega_classification": "mixed", "iodine_value": "18-36", "saponification_value": "80-105", "unsaponifiable_matter_pct": "45-55", "peroxide_value_fre…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Anti-static agent Binder Emulsifier Film former Flavouring and nutrient Fragrance Humectant Softener and conditioner Solvent Stabilizing agent
Regulatory List Membership (4)
EU Regulated in Personal Care EU Restricted for Children (Cosmetics) FDA Substances Added to Food (EAFUS) Consumer Product Chemical

Expert Verdict

Expert safety assessment and concern-level summary for Lanolin.

Regulatory Flags

eu-unrestricted cir-approved no-sccs-opinion animal-derived allergen sensitizer eu_children_restricted fda_food_additive

Known Synonyms

Caswell No. 518 EINECS 232-348-6 EPA Pesticide Chemical Code 031601 Fats and Glyceridic oils, lanoline Wollfett Adeps lanae Adeps Lanae ahydricus Lanae cera UNII-7EV65EAW6H Lantrol 1674 Lantrol 1673 Lanor crystal Dewaxed lanolin Jeelan oil Ivarlan 3100 Yofco liquid lanolin Wool oil Vigilan UNII-OVV5IIJ58F Ovis aries hair oil

Chemical Function

Softener and conditioner Humectant Surfactant (surface active agent) Anti-static agent

Regulatory Lists

active_ingredient; Europe; Pesticides inert_ingredient; Pesticides inert_ingredient; non_food_use; Pesticides Cleaning products and household care - shoes; Europe Cleaning products and household care - shoes; Europe active_ingredient; animal_products; Europe; pharmaceutical; residue Europe; Personal care children; Europe; Personal care children; Europe; Personal care - general moisturizing - hand/body lotion Europe; Personal care - make-up and related Europe; Personal care - make-up and related Europe; Personal care - liniment Europe; Personal care Europe; Personal care Europe; Personal care food_additive; Substances Added to Food (formerly EAFUS) (2/2019) Canada; pharmaceutical consumer_product

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 count match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Adverse Event Associations
10
View full pharmaceutical profile →
SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
Lanolin (Wool Fat/Grease)
Food Category
oils_fats
View full food safety profile →

Frequently Asked Questions

Is Lanolin safe in cosmetics?

Lanolin has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted.

Is Lanolin allowed in the EU?

Lanolin EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Lanolin do in cosmetics?

Lanolin functions as: Complex mixture of esters, diesters, and hydroxy esters derived from sheep wool wax. Highly effective occlusive emollient mimicking skin sebum lipid complexity. Modern ultra-refined pharmaceutical grades achieve allergen levels below detectable thresholds. Functions as emollient, occlusive, and skin-conditioning agent.. It is classified as a Emollient in our database. CAS number: 8006-54-0.

Is Lanolin used outside cosmetics?

Lanolin also appears in pharmaceutical and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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