Is Zinc Pyrithione safe in cosmetics?
Zinc Pyrithione has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Zinc Pyrithione
Also known as: Zinc, bis[1-(hydroxy-kappaO)-2(1H)-pyridinethionato-.kappa.S2]-, (T-4)-, Zinc, bis(1-hydroxy-2(1H)-pyridinethionato)-, Zinc, bis(1-hydroxy-2(1H)-pyridinethionato-O,S)-, (T-4)-, Zinc, bis(1-(hydroxy-kappaO)-2(1H)-pyridinethionato-kappaS2)-, (T-4)-, Zinc, bis[1-(hydroxy-.kappa.O)-2(1H)-pyridinethionato-.kappa.S2]-, (T-4)- (+14 more)
INCI: ZINC PYRITHIONE
Zinc Pyrithione (CAS 13463-41-7) is a cosmetic active ingredient functioning as Anti-dandruff active; preservative (historical EU). NOAEL 0.167 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: prohibited, max 0%. 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 13463-41-7 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Zinc Pyrithione is prohibited in EU cosmetics at max 0% but has active industrial GHS classifications (H301, H302, H318, H330, H331, H332, H372, H400).
Source: Cosmetics: ingredients.eu status/eu max; Chemicals: ghs classifications.signal word/hazard statement code
Function
Anti-dandruff active; preservative (historical EU)
Safety Rating
MODERATE
Regulatory Status
EU EU Status
prohibited
EU Max Conc.
0%
US US Status
permitted
US Notes
FDA OTC Monograph M032: 0.3–2% rinse-off for dandruff control
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Zinc Pyrithione.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Zinc Pyrithione. 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 | 0.20000000298 mg/kg bw/day | oral | rat | Subchronic | COSMOS DB |
| NOAEL | =0.6 mg/kg/d | oral | rat | NOAEL study | SCCNFP Opinion |
| NOAEL | =0.6 mg/kg/d | oral | rat | NOAEL study | SCCNFP Opinion |
| NOAEL | =0.6 mg/kg/d | oral | rat | NOAEL study | SCCNFP Opinion |
| NOAEL | =0.6 mg/kg/d | oral | rat | NOAEL study | SCCNFP Opinion |
| NOAEL | =400 mg/kg/day | oral | rat | reproductive toxicity | SCCNFP Opinion |
| NOAEL | =400 mg/kg/day | oral | rat | reproductive toxicity | SCCNFP Opinion |
| NOAEL | =400 mg/kg/day | oral | rat | reproductive toxicity | SCCNFP Opinion |
| NOAEL | =400 mg/kg/day | oral | rat | reproductive toxicity | SCCNFP Opinion |
| NOAEL | =2 mg/kg/d | oral | - | NOAEL study | SCCS Opinion |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Zinc Pyrithione across SCCS product categories, with measured dermal absorption where available.
SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Zinc Pyrithione.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| 2.5 mg/kg/day | 5 mg/kg/day | Oral | Rat | Subchronic (90-day) (90 days (gavage)) | 100 | SCCS/1614/19 (2020) |
| 1 mg/kg/day | 5 mg/kg/day | Oral | Rat | Subchronic (90-day) (90 days) | 100 | SCCS/1512/13 (2013) |
Sensitization Profile
Contact sensitization data for Zinc Pyrithione based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.3%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis
Source: ESSCA; IVDK; NACDG
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LC50 | =140 mg/m3 | Rat | inhalation | - | ECHA |
| LC50 | =1340 mg/m3 | Rat | inhalation | - | ECHA |
| LC50 | =840 mg/m3 | Rat | inhalation | - | ECHA |
| LC50 | =1030 mg/m3 | Rat | inhalation | - | ECHA |
| LD50 | >2000 mg/kg | Rat | dermal | acute | ECHA |
| LD50 | =774 mg/kg | Rat | oral | - | ECHA |
| LD50 | =302 mg/kg | Rat | oral | - | ECHA |
| LD50 | =221 mg/kg | Rat | oral | - | ECHA |
| LD50 | =269 mg/kg | Rat | oral | - | ECHA |
| LOAEL | =1.95 mg/kg-day | Rat | oral | - | ECHA |
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Health HazardAcute ToxicityCorrosiveEnvironmental Hazard
Hazard Class and Category
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Aquatic Acute 1; Aquatic Chronic 1
Hazard Statements
- H360D
- H330 Fatal if inhaled
- H301 Toxic if swallowed
- H372 Causes damage to organs through prolonged or repeated exposure
- H318 Causes serious eye damage
- H400 Very toxic to aquatic life
- H410 Very toxic to aquatic life with long lasting effects
Specific Concentration Limits / M-factors
inhalation: ATE = 0.14 mg/L dusts or mists; oral: ATE = 221.0 mg/kg bw; M = 1000; M = 10
Inserted via ATP: ATP15
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
NESIL
853 µg/cm²
GHS: 1B
Human: positive
Source: HPPT: [228] Marzulli FN and Maibach HI (1973): https://library.scconline.org/v024n07/
HRIPT Human Patch Test Studies
2 human repeat insult patch tests aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HRIPT | - | 0 | 852.5 | - | - |
| HRIPT | - | 0 | 2092.5 | - | - |
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: TR, steroidogenic enzymes
LOEC: 0.1 µM
EU status: restricted (max 2% rinse-off hair); banned in leave-on cosmetics 2024
inhibitor (steroidogenesis); modulator (TR)
Dose-Response Data Points
| Endpoint | Target | Value | Direction |
|---|---|---|---|
| Testosterone and E2 secretion; CYP19 (aromatase) disruption | steroidogenesis; TR (indirect) | EC50/IC50: LOEC ~0.1 uM (H295R); IC50 for aromatase ~0.1-1 uM; LOEC: 0.1 uM; NOEC: 0.01 uM mixed | inhibitor (steroidogenesis) |
| Estrogenic activity (MCF-7 proliferation; uterine weight) | ERα (indirect, weak) | EC50/IC50: No significant cell proliferation at non-cytotoxic concentrations (≤10⁻⁶ M); EPA EDSP ER bioactivity score 0.237; LOEC: 10⁻⁶ M (borderline cytotoxic); NOEC: N/A mixed | weak estrogenic (low potency) |
| AR agonism/antagonism | AR | EC50/IC50: No significant AR activity reported in standard assays at sub-cytotoxic concentrations; LOEC: not established; NOEC: not established mixed | weak AR activity (data limited) |
| Thyroid peroxidase enzyme activity inhibition | Thyroid peroxidase (TPO) | EC50/IC50: IC50 ~15–25 µM (rat thyroid microsomes; pyrithione moiety chelates heme iron); LOEC: ~5 µM; NOEC: not determined mixed | inhibitor |
| AR agonism/antagonism | AR | EC50/IC50: No significant AR activity at non-cytotoxic doses (<0.5 µM); LOEC: not established; NOEC: N/A mixed | not active at sub-cytotoxic concentrations |
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
Hazard classification: Restricted (Annex XVII)
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1670
(EU) 2021/1902
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: 0.5% (rinse-off only). Leave-on prohibited
SA Saudi SFDA (II - Prohibited)
JPKR Japan/Korea Cosmetics
Japan (Positive (Preservative)): max 0.010
Korea (Restricted): max 1.0
Japan (Restricted): max Wash-away: 0.10% | Leave-on: 0.010% | Mucosa: 0.010%
BRIN Brazil/India Cosmetics
Brazil: Restricted
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (10)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| JP | restricted | Wash-away: 0.10% | Leave-on: 0.010% | Mucosa: 0.010% | Wash-away: 0.10% | Leave-on: 0.010% | Mucosa: 0.010% |
| CN | restricted | 1 | (a) Anti-dandruff rinse-off hair products (b) Other rinse-off products |
| CN | permitted_preservative | 0.5 | (a) Anti-dandruff rinse-off (b) Other rinse-off |
| IN | permitted_preservative | 1.0 | hair rinse-off products only |
| IN | permitted_preservative | 0.5 | other cosmetic products (non-hair, rinse-off only) |
| GCC | restricted | 2.0 | Rinse-off hair products |
| BR | banned | - | In Brazil: permitted as rinse-off anti-dandruff 1% and non-oxidative hair dye solvent (RDC 806/2023); unlike EU where fully banned |
| BR | restricted | 1 (rinse-off) / 0.25 (leave-on) | a) Rinse-off anti-dandruff hair products: 1%; b) Leave-on anti-dandruff products: 0.25%; also: non-oxidative hair dye solvent (rinse-off): per RDC 806/2023 |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Antidandruff Shampoo | 0.3–2 | 2 | FDA |
Additional Ingredient Properties
9 property records from structured ingredient metadata.
allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "preservative", "patch_test_frequency_pct": "0.3", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA; IVDK; NACDG"}
concentration
{"min_concentration_pct": "1.0", "max_concentration_pct": "2.0", "typical_concentration_pct": "2.0", "product_type": "Anti-Dandruff Shampoo", "function_at_concentration": "Anti-dandruff", "source": "FDA OTC Monograph"}
deodorant
{"cas_number": "13463-41-7", "ingredient_class": "antimicrobial_deodorant", "mechanism_of_action": "bacterial_growth_inhibition", "antiperspirant_efficacy_sweat_reduction_pct": "0", "deodorant_efficacy_hours": "12-24", "odor_reduction_pct": "55-75", "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": "13463-41-7", "ingredient_class": "anti_dandruff", "chemical_type": "other", "substantivity_to_hair": "poor", "deposition_from_shampoo": "yes", "deposition_from_conditioner": "yes", "conditioning_mechanism": "antifungal_antibacterial", "hair_penetration": "scalp_surface", "molecular_weight_effect_on_penetration": "zinc_antimicrobial", "cuticle_smoothing": "no", "18_MEA_replacement":…
microbiome_impact
{"microbiome_effect": "negative", "prebiotic": "no", "probiotic_compatible": "no", "antimicrobial_spectrum": "broad", "preservative_effect_on_microbiome": "Antifungal; broad antibacterial; disrupts commensal balance", "skin_flora_disruption": "moderate-severe", "gut_microbiome_risk": "low", "microbiome_recovery_time": "10-14 days", "selective_antimicrobial": "no", "pathogen_inhibition": "S. epider…
pediatric_safety
{"safe_for_newborn_0_6m": "avoid", "safe_for_infant_6_12m": "caution", "safe_for_toddler_1_3y": "caution", "safe_for_child_3_12y": "yes", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "0.0", "adult_max_concentration_pct": "2.0", "pediatric_dermal_absorption_factor": "moderate", "immature_skin_barrier_risk": "moderate", "oral_ingestion_risk": "moderate", "eye_irritation_risk": "…
pregnancy_detail
{"pregnancy_safe": "insufficient-data", "breastfeeding_safe": "insufficient-data", "risk_category": "not-rated", "reason": "Anti-dandruff; limited pregnancy-specific data", "alternative_ingredient": "Piroctone Olamine", "source": "dermatology literature"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-dandruff
Biocide
Degradant/impurity
Pharmaceutical
Preservative
Processing aids not otherwise specified
Softener and conditioner
Expert Verdict
Expert safety assessment and concern-level summary for Zinc Pyrithione.
Regulatory Flags
eu-banned
cmr-1b
reproductive-toxicant
otc-drug-us
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Zinc Pyrithione by CAS number or substance name.
Studies
53
Lowest NOAEL
0.20000000298
Highest NOAEL
2000
Units vary across source rows: mg/kg bw/day, mg/kg/d, mg/kg bw/d
COSMOS DB
ECHA
SCCNFP Opinion
SCCS Opinion
Known Synonyms
Zinc, bis[1-(hydroxy-kappaO)-2(1H)-pyridinethionato-.kappa.S2]-, (T-4)-
Zinc, bis(1-hydroxy-2(1H)-pyridinethionato)-
Zinc, bis(1-hydroxy-2(1H)-pyridinethionato-O,S)-, (T-4)-
Zinc, bis(1-(hydroxy-kappaO)-2(1H)-pyridinethionato-kappaS2)-, (T-4)-
Zinc, bis[1-(hydroxy-.kappa.O)-2(1H)-pyridinethionato-.kappa.S2]-, (T-4)-
Bis(2-pyridinethiol-1-oxide)zinc
Bis(2-pyridylthio)zinc 1,1'-dioxide
Breck One Dandruff Shampoo
Caswell No. 923
EINECS 236-671-3
EPA Pesticide Chemical Code 088002
Head and Shoulders
2-Pyridinethiol-1-oxide, zinc salt
Top Brass
Vancide ZP
Wella Crisan
Zinc - pyrion
Zinc, bis(2-pyridylthio)-, 1,1'-dioxide
Zinc PT
Chemical Function
Preservative
Softener and conditioner
Pharmaceutical
Anti-dandruff
Biocide
Regulatory Lists
pharmaceutical
active_ingredient; Europe; 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
active_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
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
PYRITHIONE ZINC
ChEMBL ID
CHEMBL1200471
Max Phase
4
Adverse Event Associations
143
Frequently Asked Questions
Is Zinc Pyrithione allowed in the EU?
Zinc Pyrithione EU regulatory status: prohibited. Maximum allowed concentration: 0%. This is based on EU Regulation 1223/2009 and its amendments.
What does Zinc Pyrithione do in cosmetics?
Zinc Pyrithione functions as: Anti-dandruff active; preservative (historical EU). It is classified as a Active Ingredient in our database. CAS number: 13463-41-7.
What is the NOAEL for Zinc Pyrithione?
The NOAEL (No Observed Adverse Effect Level) for Zinc Pyrithione is 0.20000000298 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS DB.
Is Zinc Pyrithione used outside cosmetics?
Zinc Pyrithione 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 Zinc Pyrithione have different safety status in cosmetics vs industrial chemicals?
Zinc Pyrithione is prohibited in EU cosmetics at max 0% but has active industrial GHS classifications (H301, H302, H318, H330, H331, H332, H372, H400).
Compliance Tools
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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