Is Polyaminopropyl Biguanide safe in cosmetics?
Polyaminopropyl Biguanide has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Polyaminopropyl Biguanide
INCI: POLYAMINOPROPYL BIGUANIDE
Polyaminopropyl Biguanide (CAS 32289-58-0) is a cosmetic preservative functioning as Preservative (Broad-Spectrum Antimicrobial). NOAEL 13.3333 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 0.1%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 32289-58-0 →
Auto-generated CPSR Part A draft with source citations
Function
Preservative (Broad-Spectrum Antimicrobial)
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
N'-[6-[(N'-methylcarbamimidoyl)amino]hexyl]ethanimidamide
InChIKey
SAGIGHPRUJPLKX-UHFFFAOYSA-N
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.1%
US US Status
permitted
US Notes
CIR 2020: safe when formulated to be non-irritating/non-sensitizing. CMR Cat. 2 per EU.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Polyaminopropyl Biguanide.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Polyaminopropyl Biguanide. 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 | =3.1 mg/kg bw/d | oral | rat | NOAEL study | SCCS_vision_codex |
| NOAEL | =3.1 mg/kg bw/d | oral | rat | NOAEL study | SCCS_vision_codex |
| NOAEL | =3.1 mg/kg bw/d | oral | rat | NOAEL study | SCCS_vision_codex |
| NOAEL | =3.1 mg/kg bw/d | oral | rat | NOAEL study | SCCS_vision_codex |
| NOAEL | =3.1 mg/kg bw/d | oral | rat | NOAEL study | SCCS_vision_codex |
| NOAEL | =3.1 mg/kg bw/d | oral | rat | NOAEL study | SCCS_vision_codex |
| NOAEL | =3.1 mg/kg bw/d | oral | rat | NOAEL study | SCCS_vision_codex |
| NOAEL | =3.1 mg/kg bw/d | oral | rat | NOAEL study | SCCS_vision_codex |
| NOAEL | =10 mg/kg/d | oral | rabbit | developmental toxicity | SCCS_vision_codex |
| NOAEL | =10 mg/kg/d | oral | rabbit | developmental toxicity | SCCS_vision_codex |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Polyaminopropyl Biguanide across SCCS product categories, with measured dermal absorption where available.
Sensitization Profile
Contact sensitization data for Polyaminopropyl Biguanide 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
formaldehyde-releaser-group
Reaction Type
contact-dermatitis
Source: ESSCA 2019/20; IVDK; FDA
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: 0.05%. Aerosol prohibited
JPKR Japan/Korea Cosmetics
Japan (Positive (Preservative)): max 0.1
Japan (Restricted): max Wash-away: 0.1% | Leave-on: 0.1% | Mucosa: Prohibited
Korea (Restricted): max 0.1%
Additional Jurisdictional Restrictions (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| JP | restricted | Wash-away: 0.1% | Leave-on: 0.1% | Mucosa: Prohibited | Wash-away: 0.1% | Leave-on: 0.1% | Mucosa: Prohibited |
| CN | permitted_preservative | 0.3 | All cosmetics |
| BR | permitted_preservative | 0.1 | Prohibited in products that can cause inhalation exposure (sprays etc.) |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (1 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_sccs_opinion | 10.0% | - | - | SCCS/1535/14 |
Additional Ingredient Properties
2 property records from structured ingredient metadata.
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": "IVDK; SCCS"}
deodorant
{"cas_number": "32289-58-0", "ingredient_class": "antimicrobial_deodorant", "mechanism_of_action": "bacterial_growth_inhibition", "antiperspirant_efficacy_sweat_reduction_pct": "0", "deodorant_efficacy_hours": "24", "odor_reduction_pct": "60-80", "bacteriostatic": "yes", "bactericidal": "yes", "target_bacteria": "broad_spectrum", "microbiome_impact": "broad", "axillary_microbiome_effect": "varies …
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Skin Eye Respiratory Irritation
... Irritating to skin ... Moderately irritating to the eye ... Irritating to the respiratory tract
Source: Hazardous Substances Data Bank (HSDB)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Preservative
Regulatory List Membership (2)
EU Regulated in Personal Care
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Polyaminopropyl Biguanide.
Regulatory Flags
EU_RESTRICTED
BANNED_SOME
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Polyaminopropyl Biguanide by CAS number or substance name.
Studies
92
Lowest NOAEL
3.1
Highest NOAEL
224
Units vary across source rows: mg/kg bw/day, mg/kg bw/d, mg/kg bw
SCCS_vision_codex
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 10.0% | SCCS opinion extraction | - |
Chemical Function
Preservative
Biocide
Regulatory Lists
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
active_ingredient; Pesticides
active_ingredient; Pesticides
pharmaceutical
Canada; pharmaceutical
Canada; pharmaceutical
active_ingredient; Pesticides
active_ingredient; Pesticides
Canada; consumer_product; Substances in Products - Canada (4/2014)
Europe; Personal care
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
polihexanide
ChEMBL ID
CHEMBL2106939
Adverse Event Associations
75
Frequently Asked Questions
Is Polyaminopropyl Biguanide allowed in the EU?
Polyaminopropyl Biguanide EU regulatory status: restricted. Maximum allowed concentration: 0.1%. This is based on EU Regulation 1223/2009 and its amendments.
What does Polyaminopropyl Biguanide do in cosmetics?
Polyaminopropyl Biguanide functions as: Preservative (Broad-Spectrum Antimicrobial). It is classified as a Preservative in our database. CAS number: 32289-58-0.
What is the NOAEL for Polyaminopropyl Biguanide?
The NOAEL (No Observed Adverse Effect Level) for Polyaminopropyl Biguanide is =3.1 mg/kg bw/d based on a NOAEL study study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS_vision_codex.
Is Polyaminopropyl Biguanide used outside cosmetics?
Polyaminopropyl Biguanide also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Polyaminopropyl Biguanide 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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