Is Kaolin Aluminum Hydroxide safe in cosmetics?
Kaolin Aluminum Hydroxide has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 2 toxicological study endpoint(s) are available in our database.
Kaolin Aluminum Hydroxide
Also known as: Al(OH)3, Alum, Aluminum hydroxide (Al(OH)3), Aluminum(III) hydroxide, British aluminum AF 260 (+6 more)
INCI: ALUMINUM HYDROXIDE
Kaolin Aluminum Hydroxide (CAS 21645-51-2) is a cosmetic cosmetic ingredient functioning as Opacifying, Emollient, Buffering. Reported NOAEL =92 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 and pharmaceutical data.
View industrial chemical safety profile for CAS 21645-51-2 →
Function
Opacifying, Emollient, Buffering
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
Chemistry & Identifiers
IUPAC Name
aluminum trihydroxide
InChIKey
WNROFYMDJYEPJX-UHFFFAOYSA-K
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
CIR reviewed; considered safe as used in cosmetics; chemically inert in topical application
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Kaolin Aluminum Hydroxide.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
2 study endpoints found for Kaolin Aluminum Hydroxide. 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 | =92 mg/kg bw/day | oral | Mouse | reproduction developmental | ECHA |
| NOAEL | =266 mg/kg bw/day | oral | Rat | reproduction developmental | ECHA |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Routes of Exposure
The substance can be absorbed into the body by inhalation.
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000,000 - 10,000,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (4)
Carcinogen Classification
Not listed by IARC. IARC classified aluminum production as carcinogenic to humans (Group 1), but did not implicate aluminum itself as a human carcinogen. (L135) A link between use of aluminum-containing antiperspirants and increased risk of breast cancer has been proposed (A235), but studies have not been able to establish a clear link (A15468).
Source: Toxin and Toxin Target Database (T3DB)
Evidence for Carcinogenicity
A4: Not classifiable as a human carcinogen. /Aluminum metal and insouble compound/
Source: Hazardous Substances Data Bank (HSDB)
ICSC Safety Card
0373
Source: WHO/JECFA
Skin Eye Respiratory Irritation
Irritation of the eyes has been noted in patients who have been exposed /to aluminum alkyls/. /Aluminum alkyls/ | Irritation skin, respiratory system.
Source: Hazardous Substances Data Bank (HSDB)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Adhesion/cohesion promoter
Binder
Catalyst
Conductive agent
Degradant/impurity
Dye
Filler
Flame retardant
Humectant
No specific technical function
Regulatory List Membership (2)
EU Regulated in Personal Care
FDA Substances Added to Food (EAFUS)
Editorial summary
Preliminary editorial summary for Kaolin Aluminum Hydroxide — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
inorganic
opacifier
buffering-agent
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Kaolin Aluminum Hydroxide by CAS number or substance name.
Studies
2
Lowest NOAEL
92 mg/kg bw/day
Highest NOAEL
266 mg/kg bw/day
ECHA
Known Synonyms
Al(OH)3
Alum
Aluminum hydroxide (Al(OH)3)
Aluminum(III) hydroxide
British aluminum AF 260
EINECS 244-492-7
Martinal
Trihydrated alumina
Alugelibye
UNII-5QB0T2IUN0
Aluminum hydroxide, dried
Chemical Function
Humectant
Softener and conditioner
Viscosity modifier
Opacifer
Regulatory Lists
drinking_water; Europe; manufacturing; plastic_additive
active_ingredient; animal_products; Europe; pharmaceutical; residue
Europe; plastic_additive
Arts and crafts/Office supplies - general arts and crafts supplies - arts and crafts paint; Europe
inert_ingredient; Pesticides
Europe; Personal care
Europe; Personal care
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; pharmaceutical
Canada; pharmaceutical
inert_ingredient; non_food_use; 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
ALUMINUM HYDROXIDE
ChEMBL ID
CHEMBL1200706
Max Phase
4
Adverse Event Associations
888
Frequently Asked Questions
Is Kaolin Aluminum Hydroxide allowed in the EU?
Kaolin Aluminum Hydroxide EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Kaolin Aluminum Hydroxide do in cosmetics?
Kaolin Aluminum Hydroxide functions as: Opacifying, Emollient, Buffering. It is classified as a cosmetic ingredient in our database. CAS number: 21645-51-2.
What is the NOAEL for Kaolin Aluminum Hydroxide?
The NOAEL (No Observed Adverse Effect Level) for Kaolin Aluminum Hydroxide is =92 mg/kg bw/day based on a reproduction developmental study via oral route in Mouse. A total of 2 study endpoints are available. Source: ECHA.
Is Kaolin Aluminum Hydroxide used outside cosmetics?
Kaolin Aluminum Hydroxide 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
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Ingredient Decoder
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Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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