What is the NOAEL for Polihexanide?
Polihexanide has 100 NOAEL studies in the database. The lowest reported value is 0 mg/kg bw/day via oral in dog (beagle; beagle). Source: ToxRefDB_ToxRefDB_v3_pod.csv.
NOAEL Data
Cosmetic Ingredient
Polihexanide
Also known as: Poly(iminoimidocarbonyliminoimidocarbonyliminohexamethylene) hydrochloride, PHMB, Cosmoquil PG, BG-IR, Biobac ZS (+15 more)
CAS 32289-58-0
Polihexanide (CAS 32289-58-0) is a chemical substance. Key regulatory status: 18 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, SCCS.
View cosmetic safety profile for Polyaminopropyl Biguanide →
Cross-Vertical Regulatory Divergence
Polihexanide is classified GHS Danger (H302, H317, H318, H330, H351, H372, H410, H400) in the chemicals database but is restricted in EU cosmetics at max 0.1%.
SOURCE
Cross-vertical comparison
Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code
SOURCE
noael studies public
NOAEL studies
100
SOURCE
chemical inventory jurisdictions
Regulatory lists
18
SOURCE
eu clp annex vi
GHS signal
Not classified
Chemical Identity
CAS, identifiers, formula, and alternate names for the matched substance record.
SOURCE
DSSTox identifiers
23 fields
Name
Polihexanide
CAS Number
32289-58-0
DTXSID
DTXSID2035726
Synonyms
Poly(iminoimidocarbonyliminoimidocarbonyliminohexamethylene) hydrochloridePHMBCosmoquil PGBG-IRBiobac ZSBiodoctorMarukacide AVMediscrubProntodermProntosanReputex 20Trigene
Functional Uses
Industrial and product-use categories associated with this substance.
SOURCE
EPA CPDat
2 records
PreservativeBiocide
Regulatory Lists
Inventory, screening, and regulatory list matches from public chemical databases.
SOURCE
EPA CPDat
18 records
| List | Keyword | Source |
|---|---|---|
| active_ingredient; Pesticides | MN Department of Agriculture Pesticide Sales Database | CPCat |
| active_ingredient; Pesticides | MN Department of Agriculture Pesticide Sales Database | CPCat |
| active_ingredient; Pesticides | MN Department of Agriculture Pesticide Sales Database | CPCat |
| active_ingredient; Pesticides | MN Department of Agriculture Pesticide Sales Database | CPCat |
| active_ingredient; Pesticides | MN Department of Agriculture Pesticide Sales Database | CPCat |
| active_ingredient; Pesticides | MN Department of Agriculture Pesticide Sales Database | CPCat |
| active_ingredient; Pesticides | MN Department of Agriculture Pesticide Sales Database | CPCat |
| active_ingredient; Pesticides | MN Department of Agriculture Pesticide Sales Database | CPCat |
| active_ingredient; Pesticides | MN Department of Agriculture Pesticide Sales Database | CPCat |
| active_ingredient; Pesticides | MN Department of Agriculture Pesticide Sales Database | CPCat |
| active_ingredient; Pesticides | MN Department of Agriculture Pesticide Sales Database | CPCat |
| pharmaceutical | US International Trade Commission | CPCat |
| Canada; pharmaceutical | DrugBank | DrugBank |
| Canada; pharmaceutical | DrugBank | DrugBank |
| active_ingredient; Pesticides | MN Department of Agriculture Pesticide Sales Database | CPCat |
| active_ingredient; Pesticides | MN Department of Agriculture Pesticide Sales Database | CPCat |
| Canada; consumer_product; Substances in Products - Canada (4/2014) | Government of Canada | CPCat |
| Europe; Personal care | European Commission | CosIng |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 50 of 100 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| 1 | - | - | oral | - | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| =3.1 | mg/kg bw/d | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| =3.1 | mg/kg bw/d | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| =3.1 | mg/kg bw/d | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| =3.1 | mg/kg bw/d | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 8.5 | % | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 8.5 | % | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 8.5 | % | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 20 | % | - | oral | mouse | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 20.2 | % | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 20.2 | % | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| =36 | mg/kg bw/d | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| =36 | mg/kg bw/d | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| =36 | mg/kg bw/d | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 54 | mg/kg bw/d | - | - | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 54 | mg/kg bw/d | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 54 | mg/kg bw/d | - | - | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 92.3 | mg/kg bw/d | - | oral | mouse | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 92.3 | mg/kg bw/d | - | oral | - | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 224 | mg/kg bw/d | - | - | - | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 224 | mg/kg bw/d | - | oral | rat | UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
| 4XI6112496 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 4XI6112496 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 4XI6112496 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 4XI6112496 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| =7.5 | mg/kg bw/day | LEL | oral | Dog | ToxValDB_ToxRefDB |
| =7.5 | mg/kg bw/day | LEL | oral | dog (beagle; beagle) | ToxRefDB_ToxRefDB_v3_pod.csv |
| =40 | mg/kg bw/day | LEL | oral | Rabbit | ToxValDB_ToxRefDB |
| =40 | mg/kg bw/day | LEL | oral | rabbit (new zealand white; New Zealand White) | ToxRefDB_ToxRefDB_v3_pod.csv |
| =45.3 | mg/kg bw/day | LEL | oral | Rat | ToxValDB_ToxRefDB |
| =45.3 | mg/kg bw/day | LEL | oral | rat (sprague dawley; Alpk: APSD) | ToxRefDB_ToxRefDB_v3_pod.csv |
| =55 | mg/kg bw/day | LEL | oral | Mouse | ToxValDB_ToxRefDB |
| =55 | mg/kg bw/day | LEL | oral | mouse (cd1) | ToxRefDB_ToxRefDB_v3_pod.csv |
| =60 | mg/kg bw/day | LEL | dermal | Rat | ToxValDB_ToxRefDB |
| =60 | mg/kg bw/day | LEL | dermal | rat (sprague dawley; Alpk: APSD) | ToxRefDB_ToxRefDB_v3_pod.csv |
| =69.6 | mg/kg bw/day | LEL | oral | Rat | ToxValDB_ToxRefDB |
| =69.6 | mg/kg bw/day | LEL | oral | rat (sprague dawley; Alpk: APSD) | ToxRefDB_ToxRefDB_v3_pod.csv |
| =217 | mg/kg bw/day | LEL | oral | Mouse | ToxValDB_ToxRefDB |
| =217 | mg/kg bw/day | LEL | oral | mouse (cd1) | ToxRefDB_ToxRefDB_v3_pod.csv |
| =258.2 | mg/kg bw/day | LEL | oral | Rat | ToxValDB_ToxRefDB |
| =258.2 | mg/kg bw/day | LEL | oral | rat (sprague dawley; Alpk: APSD) | ToxRefDB_ToxRefDB_v3_pod.csv |
| =270.5 | mg/kg bw/day | LEL | oral | Rat | ToxValDB_ToxRefDB |
| =270.5 | mg/kg bw/day | LEL | oral | rat (sprague dawley; Alpk: APSD) | ToxRefDB_ToxRefDB_v3_pod.csv |
| =275 | mg/kg bw/day | LEL | oral | Dog | ToxValDB_ToxRefDB |
| =275 | mg/kg bw/day | LEL | oral | dog (beagle) | ToxRefDB_ToxRefDB_v3_pod.csv |
| =75 | mg/kg bw/day | LOAEL | oral | Dog | ToxValDB_ToxRefDB |
| =75 | mg/kg bw/day | LOAEL | oral | dog (beagle; beagle) | ToxRefDB_ToxRefDB_v3_pod.csv |
| >126.1 | mg/kg bw/day | LOAEL | oral | Rat | ToxValDB_ToxRefDB |
| >126.1 | mg/kg bw/day | LOAEL | oral | rat (sprague dawley; Alpk: APSD) | ToxRefDB_ToxRefDB_v3_pod.csv |
| =167 | mg/kg bw/day | LOAEL | oral | Mouse | ToxValDB_ToxRefDB |
Showing 50 of 100 studies
SCCS Opinions
EU Scientific Committee opinions tied to the matched substance.
SOURCE
EU SCCS
1 opinions
| Opinion | Date | Conclusion | Max Conc. | Concerns |
|---|---|---|---|---|
| SCCS/1535/14 | 13 July 2015 | not safe (most cosmetic uses) | 0.1% in rinse-off cosmetics only (specific uses) | CMR 2 classification concerns; genotoxicity and carcinogenicity potential; not safe for most cosmetic applications |
Cosmetic Safety Profile
Same-CAS cosmetic ingredient record for cross-vertical context.
SOURCE
CosIng / Ingredients DB
EU Status
restricted
Max
0.1%
Category
preservative
Pharmaceutical Data
Same-CAS pharmaceutical records from drug and bioactivity sources.
SOURCE
EMBL-EBI ChEMBL
polihexanide
ChEMBL Phase
Not listed
Adverse Events
75
Bioactivity
0
Frequently Asked Questions
What regulatory lists include Polihexanide?
Polihexanide appears on 5 regulatory/inventory lists including active_ingredient; Pesticides, pharmaceutical, Canada; pharmaceutical, and 2 more. Source: EPA CPDat.
Is Polihexanide used in cosmetics?
Yes, Polihexanide is also indexed as a cosmetic ingredient under the name Polyaminopropyl Biguanide. View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.
Where does the safety data for Polihexanide come from?
Safety data is sourced from EPA ToxValDB, EPA CPDat, EPA DSSTox, CosIng / Ingredients DB, ChEMBL / DailyMed. All data traces to primary regulatory sources and is updated from official government databases.
Does Polihexanide have different safety status in cosmetics vs industrial chemicals?
Polihexanide is classified GHS Danger (H302, H317, H318, H330, H351, H372, H410, H400) in the chemicals database but is restricted in EU cosmetics at max 0.1%.
Is Polihexanide used outside industrial chemicals?
Polihexanide also appears in cosmetics, pharmaceutical databases.