Is Undecylenic Acid safe in cosmetics?
Undecylenic Acid has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 2 toxicological study endpoint(s) are available in our database.
Undecylenic Acid
Also known as: 4-02-00-01612, BRN 1762631, Caswell No. 901, Desenex, EINECS 203-965-8 (+14 more)
INCI: UNDECYLENIC ACID
Undecylenic Acid (CAS 112-38-9) is a cosmetic active ingredient functioning as Antifungal; scalp care active. Reported NOAEL =150 mg/kg bw/day in Rat (ToxValDB_ECHA_IUCLID); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 112-38-9 →
Auto-generated CPSR Part A draft with source citations
Function
Antifungal; scalp care active
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
undec-10-enoic acid
InChIKey
FRPZMMHWLSIFAZ-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
FDA OTC Monograph M016 (antifungal): 10-25% for superficial skin fungal infections. Not listed in OTC Dandruff Monograph M032. Cosmetic use at lower concentrations does not trigger OTC drug requirements.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Undecylenic Acid.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
2 study endpoints found for Undecylenic Acid. 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 | =150 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =450 mg/kg bw/day | oral | Rat | developmental | ToxValDB_ECHA_IUCLID |
Sensitization Profile
Contact sensitization data for Undecylenic Acid based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.1%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis
Source: ESSCA; IVDK; NACDG
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
11.4%
DPRA Lys %
-0.1%
KeratinoSens IC50
2000 µM
NESIL
2700 µg/cm²
GHS: 1B
Human: positive
Source: DPRA: Bauch et al. 2012 [DOI:10.1016/j.yrtph.2012.05.013]; KS: Bauch et al. 2012 [DOI:10.1016/j.yrtph.2012.05.013]; HPPT: [191] Kligman AM (1976): Report to RIFM, 18 May, unpublished.
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 | 2700 | - | - |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10,000 - 100,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
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 (5)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_preservative | 0.2 | Oral care products |
| IN | permitted_preservative | 0.2 | all cosmetics |
| BR | restricted | 2 | Anti-dandruff products only |
| BR | permitted_preservative | 0.2 | 0.2% as undecylenic acid |
| ASEAN | permitted_preservative | 0.2% as acid | All products |
Additional Ingredient Properties
5 property records from structured ingredient metadata.
allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "preservative", "patch_test_frequency_pct": "0.1", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA; IVDK; NACDG"}
deodorant
{"cas_number": "112-38-9", "ingredient_class": "antimicrobial_deodorant", "mechanism_of_action": "bacterial_growth_inhibition", "antiperspirant_efficacy_sweat_reduction_pct": "0", "deodorant_efficacy_hours": "8-12", "odor_reduction_pct": "45-65", "bacteriostatic": "yes", "bactericidal": "yes", "target_bacteria": "broad_spectrum", "microbiome_impact": "selective", "axillary_microbiome_effect": "ant…
emulsion_hlb
{"hlb_required_as_emulsifier": "no", "hlb_required_of_oil_phase": "16-17", "co_emulsifier_pairs": "sodium_hydroxide,potassium_hydroxide", "optimal_oil_phase_pct": "8-22", "optimal_water_phase_pct": "78-92", "droplet_size_range_um": "3-30", "creaming_resistance": "moderate", "coalescence_resistance": "good", "ostwald_ripening_resistance": "moderate", "freeze_thaw_stability": "poor", "rheology_modif…
preservative
{"preservative_class": "Fatty acid", "antimicrobial_spectrum_bacteria_gp": "Moderate", "antimicrobial_spectrum_bacteria_gn": "Good", "antimicrobial_spectrum_yeast": "Yes", "antimicrobial_spectrum_mold": "Yes", "mic_staph_aureus_ppm": "600", "mic_e_coli_ppm": "700", "mic_pseudomonas_ppm": "900", "mic_candida_albicans_ppm": "1400", "mic_aspergillus_niger_ppm": "2000", "challenge_test_pass_concentrat…
solubility_hlb
{"water_soluble": "no", "oil_soluble": "yes", "hlb_required": "12.0", "soluble_in": "oils, ethanol", "insoluble_in": "water, glycerin, propylene glycol", "log_p": "4.7", "melting_point_c": "24-25", "appearance": "pale yellow liquid", "source": "BASF"}
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Carcinogen Classification
No indication of carcinogenicity to humans (not listed by IARC).
Source: Toxin and Toxin Target Database (T3DB)
Regulatory (3)
JECFA Number
331
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
10-UNDECENOIC ACID | 2023 | Not considered | JECFA requests that updated exposure data (including both MSDI and SPET values) be provided for the flavouring agents cis-3-hexen-1-ol (No. 315), 10-undecenal (No. 330), 10-undecenoic acid (No. 331), cis-3-hexenyl cis3-hexenoate (No. 336), 5-hexenol (No. 1623) and methyl 10-undecenoate (No. 1639) within 2 years (i.e. by December 2025) so that a re-evalu
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
UNDECYL-10-ENIC ACID | 2023 | Not considered | JECFA requests that updated exposure data (including both MSDI and SPET values) be provided for the flavouring agents cis-3-hexen-1-ol (No. 315), 10-undecenal (No. 330), 10-undecenoic acid (No. 331), cis-3-hexenyl cis3-hexenoate (No. 336), 5-hexenol (No. 1623) and methyl 10-undecenoate (No. 1639) within 2 years (i.e. by December 2025) so that a re-eva
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Cleaning agent
Emulsifier
Flavouring and nutrient
Fragrance
Preservative
Surfactant (surface active agent)
Regulatory List Membership (6)
EU Regulated in Personal Care
IFRA Fragrance Transparency List
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
Consumer Product Chemical
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Undecylenic Acid.
Regulatory Flags
antifungal
otc-drug-us-m016
cosmetic-low-concentration
epa_safer_alternative
ifra_fragrance
fda_food_additive
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Undecylenic Acid by CAS number or substance name.
Studies
2
Lowest NOAEL
150 mg/kg bw/day
Highest NOAEL
450 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
4-02-00-01612
BRN 1762631
Caswell No. 901
Desenex
EINECS 203-965-8
EPA Pesticide Chemical Code 085501
FEMA No. 3247
Hendecenoic acid, omega-
Undecenoic acid, omega-
Undecyl-10-enic acid
9-Undecylenic acid
Kyselina 9-decen-1-karboxylova
Kyselina undecylenova
UNII-K3D86KJ24N
Undecen-10-saeure
Undecenoic acid
acide 10-undecanoique
acide 10-undecylique
acido 10-undecenoico
Chemical Function
Surfactant (surface active agent)
Preservative
Emulsifier
Cleaning agent
Fragrance
Biocide
Regulatory Lists
Europe; Personal care
active_ingredient; Europe; Pesticides
Europe
active_ingredient; Australia
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
Europe; Personal care - body hygiene - hand soap
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
UNDECYLENIC ACID
ChEMBL ID
CHEMBL1276010
Max Phase
-1
Adverse Event Associations
84
Frequently Asked Questions
Is Undecylenic Acid allowed in the EU?
Undecylenic Acid EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Undecylenic Acid do in cosmetics?
Undecylenic Acid functions as: Antifungal; scalp care active. It is classified as a Active Ingredient in our database. CAS number: 112-38-9.
What is the NOAEL for Undecylenic Acid?
The NOAEL (No Observed Adverse Effect Level) for Undecylenic Acid is =150 mg/kg bw/day based on a reproduction developmental study via oral route in Rat. A total of 2 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.
Is Undecylenic Acid used outside cosmetics?
Undecylenic Acid also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Undecylenic Acid compliance across multiple jurisdictions:
Ingredient Decoder
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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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