Moderate Fragrance NOAEL Data Sensitization Data Dermal Penetration

Hydroxycitronellal

INCI: HYDROXYCITRONELLAL

CAS Number
107-75-5
Function
Fragrance ingredient
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. Mandatory labeling in leave-on products at >0.001%; rinse-off >0.01%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes IFRA restricts by product category; widely used synthetic fragrance ingredient

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.

Toxicological Studies

2 study endpoints found for Hydroxycitronellal. 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 5000 ppm oral rat oral REACH
NOAEL 250 other oral rat oral REACH

Sensitization Profile

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

Sensitization Rate
moderate
Allergen Class
fragrance
EU Allergen Listed
yes
Patch Test Positive Rate
1.2%
Cross-reactivity Group
fragrance-mix-I
Reaction Type
contact-dermatitis
IFRA Restricted โ€” max 1.0% in finished products

Source: ESSCA/IVDK

Dermal Penetration Profile

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

Absorption %
18-28%
Penetration Level
epidermis
Penetration Depth
epidermis/dermis
Molecular Weight
172.3 Da
Log P
1.3
Systemic Absorption
yes
Topical Bioavailability
12-24%
Safety Margin Factor
high
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: SCCS/1459/11, IFRA

Expert Verdict

Synthetic fragrance allergen (FM I component) with documented sensitization potential listed in EU Annex III requiring mandatory labeling; sensitization confirmed by DPRA and KeratinoSens non-animal test methods with IFRA restrictions by product category.

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Concern Level: Moderate

Regulatory Flags

fragrance-allergen eu-annex-iii fm-i patch-test-standard mandatory-label eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive eu_cosing_listed jecfa_safe

Frequently Asked Questions

Is Hydroxycitronellal safe in cosmetics?

Synthetic fragrance allergen (FM I component) with documented sensitization potential listed in EU Annex III requiring mandatory labeling; sensitization confirmed by DPRA and KeratinoSens non-animal test methods with IFRA restrictions by product category. The EU classifies Hydroxycitronellal as "restricted". Safety rating: MODERATE. 2 toxicological study endpoint(s) are available in our database.

Is Hydroxycitronellal allowed in the EU?

Hydroxycitronellal EU regulatory status: restricted. Maximum allowed concentration: Mandatory labeling in leave-on products at >0.001%; rinse-off >0.01%. This is based on EU Regulation 1223/2009 and its amendments.

What does Hydroxycitronellal do in cosmetics?

Hydroxycitronellal functions as: Fragrance ingredient. It is classified as a Fragrance in our database. CAS number: 107-75-5.

What is the Margin of Safety for Hydroxycitronellal?

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 Hydroxycitronellal?

The NOAEL (No Observed Adverse Effect Level) for Hydroxycitronellal is 5000 ppm based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.

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