EXCELLENT Cosmetic Ingredient NOAEL Data

Cyclodextrin

Also known as: 2,4,7,9,12,14,17,19,22,24,27,29,32,34-Tetradecaoxaoctacyclo[31.2.2.23,6.28,11.213,16.218,21.223,26.228,31]nonatetracontane, β-cyclodextrin deriv., B 100H, BW 7, BW 7 (polysaccharide), Stereoisomer of 5,10,15,20,25,30,35-heptakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.23,6.28,11.213,16.218,21.223,26.228,31]nonatetracontane-36,37,38,39,40,41,42,43,44,45,46,47,48,49-tetradecol (+14 more)

INCI: CYCLODEXTRIN

Cyclodextrin (CAS 7585-39-9) is a cosmetic cosmetic ingredient functioning as Absorbent, Carrier, Encapsulant, Solubilizer. Reported NOAEL =225 mg/kg bw/day in Mouse (ECHA); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.

View industrial chemical safety profile for CAS 7585-39-9 →

Function
Absorbent, Carrier, Encapsulant, Solubilizer
Editorial assessment
EXCELLENT
Preliminary editorial note — not a computed safety verdict.

Chemistry & Identifiers

Formula
C42H70O35
MW
1135 g/mol
EC Number
231-493-2
PubChem CID
444041
IUPAC Name
(1S,3R,5R,6S,8R,10R,11S,13R,15R,16S,18R,20R,21S,23R,25R,26S,28R,30R,31S,33R,35R,36R,37R,38R,39R,40R,41R,42R,43R,44R,45R,46R,47R,48R,49R)-5,10,15,20,25,30,35-heptakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.23,6.28,11.213,16.218,21.223,26.228,31]nonatetracontane-36,37,38,39,40,41,42,43,44,45,46,47,48,49-tetradecol
InChIKey
WHGYBXFWUBPSRW-FOUAGVGXSA-N

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes GRAS as food substance. No specific FDA cosmetic restrictions. Listed on TSCA inventory.

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Cyclodextrin.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

5 study endpoints found for Cyclodextrin. 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 =225 mg/kg bw/day oral Mouse chronic ECHA
NOAEL =400 mg/kg bw/day oral Rat chronic ECHA
NOAEL =975 mg/kg bw/day oral Rat chronic ECHA
NOAEL =1000 mg/kg bw/day oral Dog chronic ECHA
NOAEL =5000 mg/kg bw/day oral Rat developmental ECHA

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

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Regulatory (4)
JECFA Evaluation
CYCLODEXTRIN B | 1995 | 0-5 mg/kg bw | JECFA revised the previous temporary ADI (0-6 mg/kg bw) and allocated an ADI of 0-5 mg/kg bw for beta-cyclodextrin based on a NOEL of 1.25% in the diet (equal to 470 mg/kg bw/day) in a 1-year study in dogs and a safety factor of 100. | TRS 859-JECFA 44/28 | FAS 35-JECFA 44/257
Source: WHO/JECFA
JECFA Evaluation
beta-CYCLODEXTRIN | 1995 | 0-5 mg/kg bw | JECFA revised the previous temporary ADI (0-6 mg/kg bw) and allocated an ADI of 0-5 mg/kg bw for beta-cyclodextrin based on a NOEL of 1.25% in the diet (equal to 470 mg/kg bw/day) in a 1-year study in dogs and a safety factor of 100. | TRS 859-JECFA 44/28 | FAS 35-JECFA 44/257
Source: WHO/JECFA
JECFA Evaluation
beta-SCHARDINGER DEXTRIN | 1995 | 0-5 mg/kg bw | JECFA revised the previous temporary ADI (0-6 mg/kg bw) and allocated an ADI of 0-5 mg/kg bw for beta-cyclodextrin based on a NOEL of 1.25% in the diet (equal to 470 mg/kg bw/day) in a 1-year study in dogs and a safety factor of 100. | TRS 859-JECFA 44/28 | FAS 35-JECFA 44/257
Source: WHO/JECFA
EU Food Improvement
Food additives
Source: EU Food Improvement Agents

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Deodorizer Flavouring and nutrient Processing aids not otherwise specified
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)

Editorial summary

Preliminary editorial summary for Cyclodextrin — not a computed safety verdict. See the sourced toxicological data above.

Regulatory Flags

cir-cleared gras low-dermal-absorption encapsulant well-characterized epa_safer_alternative fda_food_additive

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Cyclodextrin by CAS number or substance name.

Studies
5
Lowest NOAEL
225 mg/kg bw/day
Highest NOAEL
5000 mg/kg bw/day
ECHA

Known Synonyms

2,4,7,9,12,14,17,19,22,24,27,29,32,34-Tetradecaoxaoctacyclo[31.2.2.23,6.28,11.213,16.218,21.223,26.228,31]nonatetracontane, β-cyclodextrin deriv. B 100H BW 7 BW 7 (polysaccharide) Stereoisomer of 5,10,15,20,25,30,35-heptakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.23,6.28,11.213,16.218,21.223,26.228,31]nonatetracontane-36,37,38,39,40,41,42,43,44,45,46,47,48,49-tetradecol Dexipar β-100 Dexy Pearl 100 HP-β-CD Kleptose STD VTS 270 CYCLODEXTRIN, β- betadex .beta.-Cyclodextrin beta-Dextrin Dextrin, beta-cyclo EINECS 231-493-2 Schardinger beta-dextrin beta-Cycloheptaamylose UNII-JV039JZZ3A

Chemical Function

Deodorizer Processing aids not otherwise specified Flavouring and nutrient

Regulatory Lists

inert_ingredient; non_food_use; Pesticides food_additive; Substances Added to Food (formerly EAFUS) (2/2019) pharmaceutical Canada; pharmaceutical

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical and food safety data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Compound
BETADEX
ChEMBL ID
CHEMBL415690
Max Phase
3
Adverse Event Associations
18
View full pharmaceutical profile →
SOURCE EFSA / FDA GRAS food_additives + fda_gras_enriched

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
Beta-cyclodextrin
E Number
E459
ADI
5 mg/kg bw
FDA GRAS
FDA has no questions
GRN
74
Food Category
emulsifier

Use in baked goods prepared from dry mixes, breakfast cereal, chewing gum, gelatins and puddings, dry mix for soups, flavored coffee and tea, compressed candies, processed cheese products, flavored savory snacks and crackers, dry mix for beverages as a flavor...

View full food safety profile →

Frequently Asked Questions

Is Cyclodextrin safe in cosmetics?

Cyclodextrin has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 5 toxicological study endpoint(s) are available in our database.

Is Cyclodextrin allowed in the EU?

Cyclodextrin EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Cyclodextrin do in cosmetics?

Cyclodextrin functions as: Absorbent, Carrier, Encapsulant, Solubilizer. It is classified as a cosmetic ingredient in our database. CAS number: 7585-39-9.

What is the NOAEL for Cyclodextrin?

The NOAEL (No Observed Adverse Effect Level) for Cyclodextrin is =225 mg/kg bw/day based on a chronic study via oral route in Mouse. A total of 5 study endpoints are available. Source: ECHA.

Is Cyclodextrin used outside cosmetics?

Cyclodextrin also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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