Moderate Fragrance NOAEL Data GHS Classified Sensitization Data Dermal Penetration

Linalool

INCI: LINALOOL

CAS Number
78-70-6
Function
fragrance; skin-conditioning
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. Mandatory individual label declaration above 10 ppm in leave-on products, 100 ppm in rinse-off products (EU 26 allergen list). IFRA 51st Amendment imposes stricter limits on linalool hydroperoxide content in formulations.
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No US federal individual fragrance ingredient disclosure requirement; listed as fragrance only under FDA rules

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 study endpoints found for Linalool. 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 1500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Developmental COSMOS_DB
dose_tested 1000 mg/kg bw/day oral rat Developmental COSMOS_DB

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Short-term Exposure Effects
The substance is irritating to the eyes and skin.
Long-term Exposure Effects
The substance may have effects on the liver.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol and by ingestion.

Sensitization Profile

Contact sensitization data for Linalool based on clinical patch test studies and IFRA standards.

Sensitization Rate
moderate
Allergen Class
fragrance
EU Allergen Listed
yes
Patch Test Positive Rate
3.5%
Cross-reactivity Group
terpene-hydroperoxide-group
Reaction Type
contact-dermatitis
IFRA Restricted

Source: ESSCA/NACDG

Dermal Penetration Profile

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

Absorption %
18-30%
Penetration Level
epidermis
Penetration Depth
epidermis/dermis
Molecular Weight
154.3 Da
Log P
2.97
Systemic Absorption
yes
Topical Bioavailability
12-25%
Safety Margin Factor
high
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: SCCS/1459/11, IFRA

Expert Verdict

Widespread natural fragrance constituent with low risk in fresh unoxidized state; oxidation transforms it into a potent allergen. Antioxidant stabilization, nitrogen blanketing during filling, and minimized headspace are essential GMP measures. Mandatory EU allergen declaration above thresholds and protection from oxidation throughout shelf life required.

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Concern Level: High

Regulatory Flags

allergen-eu sensitization-risk oxidation-sensitive ifra-restricted eu-labelling-required hydroperoxide-forming original-26-allergen eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is Linalool safe in cosmetics?

Widespread natural fragrance constituent with low risk in fresh unoxidized state; oxidation transforms it into a potent allergen. Antioxidant stabilization, nitrogen blanketing during filling, and minimized headspace are essential GMP measures. Mandatory EU allergen declaration above thresholds and protection from oxidation throughout shelf life required. The EU classifies Linalool as "restricted". Safety rating: MODERATE. 3 toxicological study endpoint(s) are available in our database.

Is Linalool allowed in the EU?

Linalool EU regulatory status: restricted. Maximum allowed concentration: Mandatory individual label declaration above 10 ppm in leave-on products, 100 ppm in rinse-off products (EU 26 allergen list). IFRA 51st Amendment imposes stricter limits on linalool hydroperoxide content in formulations.. This is based on EU Regulation 1223/2009 and its amendments.

What does Linalool do in cosmetics?

Linalool functions as: fragrance; skin-conditioning. It is classified as a Fragrance in our database. CAS number: 78-70-6.

What is the Margin of Safety for Linalool?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Linalool?

The NOAEL (No Observed Adverse Effect Level) for Linalool is 1500 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 3 study endpoints are available. Source: COSMOS_DB.

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