Is Climbazole safe in cosmetics?
Climbazole 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.
Climbazole
Also known as: 5-23-04-00209, Baypival, BRN 0618020, 1-(p-Chlorophenoxy)-3,3-dimethyl-1-(1-imidazolyl)-2-butanone, 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutanone (+4 more)
INCI: CLIMBAZOLE
Climbazole (CAS 38083-17-9) is a cosmetic active ingredient functioning as Antifungal; anti-dandruff active; preservative. NOAEL 5 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 2.0% rinse-off (anti-dandruff) / 0.5% rinse-off (preservative) / 0.2% leave-on (preservative). 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 38083-17-9 →
Function
Antifungal; anti-dandruff active; preservative
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
restricted
EU Max Conc.
2.0% rinse-off (anti-dandruff) / 0.5% rinse-off (preservative) / 0.2% leave-on (preservative)
US US Status
permitted
US Notes
Used as cosmetic anti-dandruff ingredient in the US; no OTC monograph inclusion
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Climbazole.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Climbazole. 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 | =5 mg/kg bw/day | oral | rat | NOAEL study | SCCS Opinion |
| NOAEL | =5 mg/kg/day | oral | rat | developmental toxicity | SCCS Opinion |
| NOAEL | =5 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCS Opinion |
| NOAEL | =5 mg/kg bw/day | oral | rat | NOAEL study | SCCS Opinion |
| NOAEL | =5 mg/kg/day | oral | rat | developmental toxicity | SCCS Opinion |
| NOAEL | =5 mg/kg bw/day | oral | rat | NOAEL study | SCCS Opinion |
| NOAEL | =5 mg/kg/day | oral | rat | developmental toxicity | SCCS Opinion |
| NOAEL | =5 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCS Opinion |
| NOAEL | =5 mg/kg bw/day | oral | rat | repeated dose toxicity | SCCS Opinion |
| NOAEL | =5 mg/kg bw/day | oral | rat | NOAEL study | SCCS Opinion |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Climbazole across SCCS product categories, with measured dermal absorption where available.
SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Climbazole.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| 20 mg/kg/day | 200 mg/kg/day | Oral | Rat | Subchronic (90-day) (90 days) | 100 | SCCS/1506/13 (2013) |
Sensitization Profile
Contact sensitization data for Climbazole 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
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1 - 10 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex V — Permitted Preservatives
Product type: (a) Hair lotions
(b) Face creams
(c) Foot care products
(d) Rinse-off shampoo
Max: (a) 0,2 %
(b) 0,2 %
(c) 0,2 %
(d) 0,5 %
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% (hair only). Non-hair prohibited
SA Saudi SFDA (V - Preservatives)
Product type: (a) Hair lotions (b) Face creams (c) Foot care products (d) Rinse-off shampoo. Max: (a) 0,2 % (b) 0,2 % (c) 0,2 % (d) 0,5 %.
BRIN Brazil/India Cosmetics
Brazil: Restricted
Brazil: Permitted Preservative · max a) 0,5% em xampus com enxágue. b)0,2% em cremes faciais, loções capilares e em produtos para os pés.
India: Restricted · max 2,0 %
Additional Jurisdictional Restrictions (6)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_preservative | 0.5 | Rinse-off hair products only |
| IN | permitted_preservative | 0.5 | all cosmetics |
| BR | restricted | 2 | Anti-dandruff rinse-off shampoos only; RDC 806/2023 restriction |
| BR | permitted_preservative | 0.5 (shampoo) / 0.2 (face/hair/foot) | a) Rinse-off shampoos: 0.5%; b) Face creams, hair lotions, foot care: 0.2%; As preservative (*) symbol |
| ASEAN | permitted_preservative | 0.5% | All products |
| TH | restricted | 0.5% (per ACD Annex VI) | All products containing Climbazole |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (3 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_sccs_opinion | 100.0% | - | - | SCCS/1506/13 |
| measured_sccs_opinion | 0.15% | - | - | SCCP/1204/08 |
| measured_sccs_opinion | 0.15% | - | - | SCCS/1506/13 |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-dandruff
Biocide
Preservative
Regulatory List Membership (2)
EU Regulated in Personal Care
EU CosIng Cosmetics Ingredient Database
Editorial summary
Preliminary editorial summary for Climbazole — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
eu-restricted
antifungal
endocrine-disruptor-suspected
corap-evaluation
malassezia-active
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Climbazole by CAS number or substance name.
Studies
52
Lowest NOAEL
5
Highest NOAEL
100
Units vary across source rows: mg/kg bw/day, mg/kg/day, mg/kg
SCCS Opinion
ECHA
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 100.0% | SCCS opinion extraction | - |
| 0.15% | SCCS opinion extraction | - |
| 0.15% | SCCS opinion extraction | - |
Known Synonyms
5-23-04-00209
Baypival
BRN 0618020
1-(p-Chlorophenoxy)-3,3-dimethyl-1-(1-imidazolyl)-2-butanone
1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutanone
Climbazol
EINECS 253-775-4
Climbazolum
UNII-9N42CW7I54
Chemical Function
Biocide
Preservative
Anti-dandruff
Regulatory Lists
Europe; Personal care; restricted
Europe; Personal care
active_ingredient; Australia
pharmaceutical
Europe; Personal care - hair styling and care - shampoo-dandruff
Canada; pharmaceutical
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
CLIMBAZOLE
ChEMBL ID
CHEMBL1437764
Max Phase
2
Frequently Asked Questions
Is Climbazole allowed in the EU?
Climbazole EU regulatory status: restricted. Maximum allowed concentration: 2.0% rinse-off (anti-dandruff) / 0.5% rinse-off (preservative) / 0.2% leave-on (preservative). This is based on EU Regulation 1223/2009 and its amendments.
What does Climbazole do in cosmetics?
Climbazole functions as: Antifungal; anti-dandruff active; preservative. It is classified as a Active Ingredient in our database. CAS number: 38083-17-9.
What is the NOAEL for Climbazole?
The NOAEL (No Observed Adverse Effect Level) for Climbazole is =5 mg/kg bw/day based on a NOAEL study study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS Opinion.
Is Climbazole used outside cosmetics?
Climbazole 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.
Compliance Tools
Check Climbazole 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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