Moderate Fragrance GHS Classified Sensitization Data Dermal Penetration

Limonene

INCI: LIMONENE

CAS Number
5989-27-5
Function
solvent, penetration enhancer, fragrance component
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. >0.001% leave-on, >0.01% rinse-off (mandatory label declaration)
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR reviewed as fragrance component. Potent penetration enhancer; oxidation products (limonene hydroperoxides) are potent sensitizers requiring antioxidant stabilization.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

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 skin. The substance is mildly irritating to the eyes.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization. See Notes.

Sensitization Profile

Contact sensitization data for Limonene 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 Limonene, relevant to systemic exposure and MoS calculations.

Absorption %
15-28%
Penetration Level
epidermis
Penetration Depth
epidermis
Molecular Weight
136.2 Da
Log P
4.57
Systemic Absorption
yes
Topical Bioavailability
10-24%
Safety Margin Factor
high
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: Int J Pharm 2006

Expert Verdict

Terpene solvent and penetration enhancer with fragrance note requiring EU mandatory allergen labeling above 0.001% (leave-on) or 0.01% (rinse-off). Fresh limonene has reasonable safety profile; oxidized limonene is a potent sensitizer. Antioxidant stabilization (e.g., BHT, BHA, tocopherol) is essential and peroxide value testing of raw material is required.

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Concern Level: Moderate

Regulatory Flags

eu-restricted fragrance-allergen sensitizer-oxidized penetration-enhancer eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is Limonene safe in cosmetics?

Terpene solvent and penetration enhancer with fragrance note requiring EU mandatory allergen labeling above 0.001% (leave-on) or 0.01% (rinse-off). Fresh limonene has reasonable safety profile; oxidized limonene is a potent sensitizer. Antioxidant stabilization (e.g., BHT, BHA, tocopherol) is essential and peroxide value testing of raw material is required. The EU classifies Limonene as "restricted". Safety rating: MODERATE.

Is Limonene allowed in the EU?

Limonene EU regulatory status: restricted. Maximum allowed concentration: >0.001% leave-on, >0.01% rinse-off (mandatory label declaration). This is based on EU Regulation 1223/2009 and its amendments.

What does Limonene do in cosmetics?

Limonene functions as: solvent, penetration enhancer, fragrance component. It is classified as a Fragrance in our database. CAS number: 5989-27-5.

What is the Margin of Safety for Limonene?

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.

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