Is Piroctone Olamine safe in cosmetics?
Piroctone Olamine has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Piroctone Olamine
Also known as: EINECS 272-574-2, Octopirox, UNII-A4V5C6R9FB, Kopirox
INCI: PIROCTONE OLAMINE
Piroctone Olamine (CAS 68890-66-4) is a cosmetic active ingredient functioning as Antifungal; anti-dandruff active; preservative. Reported NOAEL =16 mg/kg/day in rat (SCCNFP_vision_codex); EU Regulation 1223/2009 status: restricted, max 1.0% rinse-off / 0.5% leave-on. 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 68890-66-4 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Piroctone Olamine is classified GHS Danger (H315, H318, H335, H400, H410, H412) in the chemicals database but is restricted in EU cosmetics at max 1.0% rinse-off / 0.5% leave-on.
Source: Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Antifungal; anti-dandruff active; preservative
Safety Rating
GOOD
Regulatory Status
EU EU Status
restricted
EU Max Conc.
1.0% rinse-off / 0.5% leave-on
US US Status
permitted
US Notes
Cosmetic ingredient in the US; no OTC monograph coverage — anti-dandruff claims must remain cosmetic in nature
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Piroctone Olamine.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Piroctone Olamine. 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 | =16 mg/kg/day | oral | rat | developmental toxicity | SCCNFP_vision_codex |
| NOAEL | =16 mg/kg/day | oral | rat | developmental toxicity | SCCNFP_vision_codex |
| NOAEL | =16 mg/kg/day | oral | rat | developmental toxicity | SCCNFP_vision_codex |
| NOAEL | =16 mg/kg/day | oral | rat | developmental toxicity | SCCNFP_vision_codex |
| NOAEL | =100 mg/kg/day | oral | rat | developmental toxicity | SCCNFP_vision_codex |
| NOAEL | =100 mg/kg/day | oral | rat | developmental toxicity | SCCNFP_vision_codex |
| NOAEL | =100 mg/kg/day | oral | rat | developmental toxicity | SCCNFP_vision_codex |
| NOAEL | =100 mg/kg/day | oral | rat | developmental toxicity | SCCNFP_vision_codex |
| NOAEL | =100 mg/kg bw/day | oral | Rat | developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =225 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
Sensitization Profile
Contact sensitization data for Piroctone Olamine based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis
Source: ESSCA; IVDK; NACDG
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Cosmetic-Specific Mechanism
Category: preservative
Receptor targets: AR (limited)
LOEC: 1 µM
EU status: restricted (max 0.5% rinse-off; 0.1% face leave-on); banned in rinse-off from 2025
weak antagonist (AR)
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 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.
KR Korea MFDS Annex 2 (Restricted)
Category: Preservative. Max: 1.0% rinse-off / 0.5% other. —
JPKR Japan/Korea Cosmetics
Japan (Positive (Preservative)): max 0.05
Korea (Restricted): max 1.0
Japan (Restricted): max Wash-away: 0.05% | Leave-on: 0.05% | Mucosa: Prohibited
Additional Jurisdictional Restrictions (6)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| JP | restricted | Wash-away: 0.05% | Leave-on: 0.05% | Mucosa: Prohibited | Wash-away: 0.05% | Leave-on: 0.05% | Mucosa: Prohibited |
| CN | permitted_preservative | 0.5 | (a) Rinse-off hair (b) Leave-on |
| IN | permitted_preservative | 0.5 | leave-on products |
| IN | permitted_preservative | 1.0 | rinse-off products |
| BR | permitted_preservative | 1 (rinse) / 0.5 (leave-on) | Rinse-off: 1%; Leave-on: 0.5% |
| ASEAN | permitted_preservative | 1% (rinse-off); 0.5% (other products) | Rinse-off products; other products |
Additional Ingredient Properties
9 property records from structured ingredient metadata.
acne
{"cas_number": "68890-66-4", "anti_acne_mechanism": "antibacterial/anti_inflammatory", "comedogenicity_rating_0_to_5": "1", "acne_type_efficacy": "fungal/inflammatory", "p_acnes_mic_ug_per_ml": "50-200", "sebum_reduction_pct_clinical": "10-15", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentration_pct": "No limit", "japan_quasi_drug_anti_acne": "No", "korea…
allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "preservative", "patch_test_frequency_pct": "0.2", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA; IVDK; NACDG"}
deodorant
{"cas_number": "68890-66-4", "ingredient_class": "antimicrobial_deodorant", "mechanism_of_action": "bacterial_growth_inhibition", "antiperspirant_efficacy_sweat_reduction_pct": "0", "deodorant_efficacy_hours": "12-24", "odor_reduction_pct": "50-70", "bacteriostatic": "yes", "bactericidal": "yes", "target_bacteria": "broad_spectrum", "microbiome_impact": "broad", "axillary_microbiome_effect": "vari…
hair_care
{"hair_function": "anti-dandruff", "hair_type_suitability": "all", "curl_pattern_suitability": "all", "porosity_suitability": "all", "protein_sensitivity": "neutral", "moisture_protein_balance": "yes", "cg_method_approved": "not-a-silicone", "silicone_type": "not-a-sulfate", "sulfate_type": "no", "drying_alcohol": "no", "fatty_alcohol": "no", "heat_protectant": "yes", "color_safe": "neutral", "ker…
hair_conditioning
{"cas_number": "68890-66-4", "ingredient_class": "anti_dandruff", "chemical_type": "other", "substantivity_to_hair": "good", "deposition_from_shampoo": "yes", "deposition_from_conditioner": "yes", "conditioning_mechanism": "antifungal_antibacterial", "hair_penetration": "scalp_surface_substantive", "molecular_weight_effect_on_penetration": "hydroxypyridone_antifungal", "wet_combing_force_reduction…
microbiome_impact
{"microbiome_effect": "mixed", "prebiotic": "no", "probiotic_compatible": "limited", "antimicrobial_spectrum": "selective", "preservative_effect_on_microbiome": "Antifungal; milder than zinc pyrithione; selective pathogen inhibition", "skin_flora_disruption": "mild", "gut_microbiome_risk": "low", "microbiome_recovery_time": "5-7 days", "selective_antimicrobial": "yes", "beneficial_bacteria_support…
pediatric_safety
{"safe_for_newborn_0_6m": "caution", "safe_for_infant_6_12m": "caution", "safe_for_toddler_1_3y": "yes", "safe_for_child_3_12y": "yes", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "1.0", "adult_max_concentration_pct": "1.0", "pediatric_dermal_absorption_factor": "moderate", "immature_skin_barrier_risk": "low", "oral_ingestion_risk": "low", "eye_irritation_risk": "low", "diape…
pregnancy_detail
{"pregnancy_safe": "insufficient-data", "breastfeeding_safe": "insufficient-data", "risk_category": "not-rated", "reason": "Limited pregnancy data; likely low risk", "alternative_ingredient": "Pyrithione Zinc", "source": "dermatology literature"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Preservative
Expert Verdict
Expert safety assessment and concern-level summary for Piroctone Olamine.
Regulatory Flags
eu-restricted
antifungal
zpt-replacement
malassezia-active
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Piroctone Olamine by CAS number or substance name.
Studies
11
Lowest NOAEL
16
Highest NOAEL
250
Units vary across source rows: mg/kg bw/day, mg/kg/day
ToxValDB_ECHA_IUCLID
SCCNFP_vision_codex
Known Synonyms
EINECS 272-574-2
Octopirox
UNII-A4V5C6R9FB
Kopirox
Chemical Function
Preservative
Biocide
Regulatory Lists
active_ingredient; Europe; Pesticides
Europe; Personal care - hair styling and care - shampoo-dandruff
Europe; Personal care - hair styling and care - shampoo-dandruff
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
PIROCTONE OLAMINE
ChEMBL ID
CHEMBL2107154
Max Phase
-1
Frequently Asked Questions
Is Piroctone Olamine allowed in the EU?
Piroctone Olamine EU regulatory status: restricted. Maximum allowed concentration: 1.0% rinse-off / 0.5% leave-on. This is based on EU Regulation 1223/2009 and its amendments.
What does Piroctone Olamine do in cosmetics?
Piroctone Olamine functions as: Antifungal; anti-dandruff active; preservative. It is classified as a Active Ingredient in our database. CAS number: 68890-66-4.
What is the NOAEL for Piroctone Olamine?
The NOAEL (No Observed Adverse Effect Level) for Piroctone Olamine is =16 mg/kg/day based on a developmental toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: SCCNFP_vision_codex.
Is Piroctone Olamine used outside cosmetics?
Piroctone Olamine 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.
Does Piroctone Olamine have different safety status in cosmetics vs industrial chemicals?
Piroctone Olamine is classified GHS Danger (H315, H318, H335, H400, H410, H412) in the chemicals database but is restricted in EU cosmetics at max 1.0% rinse-off / 0.5% leave-on.
Compliance Tools
Check Piroctone Olamine compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
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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