Excellent Preservative SCCS/CIR Reviewed

Levulinic Acid

Also known as: 4-03-00-01560, Acetopropionic acid, beta-Acetylpropionic acid, BRN 0506796, EINECS 204-649-2 (+14 more)

INCI: LEVULINIC ACID

Levulinic Acid (CAS 123-76-2) is a cosmetic preservative functioning as Preservative (combination systems); antimicrobial contributor; pH adjuster. NOAEL 1000 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted; 1 safety opinion reviewed (cir). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.

View industrial chemical safety profile for CAS 123-76-2 →

Auto-generated CPSR Part A draft with source citations

Cross-Vertical Regulatory Divergence

Levulinic Acid is classified GHS Danger (H302, H315, H317, H318, H319) in the chemicals database but is allowed in EU cosmetics.

Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code

CAS Number

123-76-2

View industrial chemical safety profile →

Function

Preservative (combination systems); antimicrobial contributor; pH adjuster (mild acidification)

Safety Rating

EXCELLENT

Chemistry & Identifiers

Formula

C5H8O3

116.11 g/mol

EC Number

204-649-2

PubChem CID

11579

IUPAC Name

4-oxopentanoic acid

InChIKey

JOOXCMJARBKPKM-UHFFFAOYSA-N

ChEBI: CHEBI:45630 UNII: RYX5QG61EI Wikidata: Q903322

Regulatory Status

EU EU Status permitted

US US Status permitted

US Notes Permitted without restriction. Naturally derived from cellulose and starch hydrolysis — bio-renewable origin. No adverse FDA findings. Accepted for natural and COSMOS-certified formulations.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir

Verdict: safe

ormulations, and concluded that these ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-irritating. Keywords Cosmetic Ingredient Review, Expert Panel for Cosmetic Ingredient Safety, Safety, Cosmetics,

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Levulinic Acid across SCCS product categories, with measured dermal absorption where available.

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

100 - 1,000 tonnes

Substance Type

SUBSTANCE

SVHC Candidate

Additional Ingredient Properties

7 property records from structured ingredient metadata.

acne

{"cas_number": "123-76-2", "anti_acne_mechanism": "antibacterial", "comedogenicity_rating_0_to_5": "0-1", "acne_type_efficacy": "inflammatory", "p_acnes_mic_ug_per_ml": ">500", "sebum_reduction_pct_clinical": "0-5", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentration_pct": "Max 1-2%", "japan_quasi_drug_anti_acne": "No", "korea_functional_cosmetic_acne": "…

baby_pediatric

{"cas_number": "123-76-2", "ingredient_class": "preservative_baby_safe", "pediatric_safety_rating": "good", "minimum_age_months": "0", "neonatal_safe": "yes", "premature_infant_safe": "yes", "skin_barrier_maturity_consideration": "Natural organic acid, antimicrobial, emerging natural preservative", "transepidermal_absorption_risk_pediatric": "low", "dose_per_kg_body_weight_concern": "Safe", "skin_…

ecotoxicity

{"biodegradable": "yes", "biodegradation_days": "14-28", "bioaccumulative": "no", "aquatic_toxicity_level": "low", "coral_reef_safe": "yes", "marine_toxicity": "low aquatic toxicity", "freshwater_toxicity": "minimal impact", "endocrine_disruptor": "no", "persistent_organic_pollutant": "no", "microplastic": "no", "nano_particle": "no", "hawaii_banned": "no", "eu_restricted_environmental": "no", "pa…

microbiome_impact

{"microbiome_effect": "mixed", "prebiotic": "yes", "probiotic_compatible": "yes", "antimicrobial_spectrum": "selective", "preservative_effect_on_microbiome": "Organic acid; selective antimicrobial; supports beneficial flora through pH modulation", "skin_flora_disruption": "mild", "gut_microbiome_risk": "low", "microbiome_recovery_time": "3-5 days", "selective_antimicrobial": "yes", "beneficial_bac…

ph_stability

{"optimal_ph_min": "3.5", "optimal_ph_max": "5.5", "stable_ph_min": "3.0", "stable_ph_max": "6.0", "degrades_above_ph": "6.5", "ph_dependent_function": "Natural preservative booster", "formulation_note": "Often with sodium levulinate", "source": "Formulation literature"}

pregnancy_detail

{"pregnancy_safe": "yes", "breastfeeding_safe": "yes", "risk_category": "not-rated", "reason": "Safe; natural preservative booster", "source": "COSMOS"}

preservative

{"preservative_class": "Organic acid", "antimicrobial_spectrum_bacteria_gp": "Moderate", "antimicrobial_spectrum_bacteria_gn": "Good", "antimicrobial_spectrum_yeast": "Yes", "antimicrobial_spectrum_mold": "Yes", "mic_staph_aureus_ppm": "250", "mic_e_coli_ppm": "300", "mic_pseudomonas_ppm": "400", "mic_candida_albicans_ppm": "500", "mic_aspergillus_niger_ppm": "800", "challenge_test_pass_concentrat…

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Regulatory (8)

JECFA Number

606