Is CI 77004 (Kaolin) safe in cosmetics?
CI 77004 (Kaolin) has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted.
CI 77004 (Kaolin)
Also known as: Hydrated aluminum silicate, Altowhites, Arcilla blanca, Argilla alba, Bentone (+15 more)
INCI: CI 77004
CI 77004 (Kaolin) (CAS 1332-58-7) is a cosmetic cosmetic ingredient functioning as Colorant. Natural white clay mineral composed principally of aluminium. NOAEL 2500 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); 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 1332-58-7 →
Auto-generated CPSR Part A draft with source citations
Function
Colorant. Natural white clay mineral composed principally of aluminium silicates (kaolinite: Al2O3·2SiO2·2H2O); also known as China Clay, Pigment White 19, and Kaolin Clay. When used as a colorant in cosmetics it is declared as CI 77004; when used as an active ingredient (e.g., in OTC skin protectant or cleansing products) it is declared as KAOLIN. Imparts white opacity and matte finish to cosmetic products. Also functions as absorbent, bulking, and anticaking agent. Listed in EU Annex IV (Restriction IV/119). CIR assessed naturally-sourced clays including kaolin as safe in cosmetics (2023 Final Safety Assessment).
Safety Rating
EXCELLENT
Chemistry & Identifiers
EC Number
310-194-1
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
FDA delisted Kaolin as a standalone color additive for cosmetics on September 23, 1976 (formerly provisionally listed, delisted due to no commercial interest per FDA records at 21 CFR 186.1256). Not currently listed in 21 CFR Parts 73 or 74 as a formally approved cosmetic color additive. Kaolin is widely used in US cosmetics as a functional ingredient (absorbent, bulking agent) under its non-colorant INCI name, and is Generally Recognized as Safe (GRAS) as an indirect food additive under 21 CFR 186.1256. US formulators declaring it specifically as a colorant (CI 77004) should be aware of the delisted colorant status.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for CI 77004 (Kaolin).
Calculate MoS for your specific formulation with the MoS Calculator.
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Hazard Statements
No hazard classification according to GHS criteria
Short-term Exposure Effects
May cause mechanical irritation.
Long-term Exposure Effects
Lungs may be affected by repeated or prolongated exposure to dust particles. This may result in fibrosis (kaolinosis).
Routes of Exposure
Exposure mainly occurs via inhalation.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for CI 77004 (Kaolin) across SCCS product categories, with measured dermal absorption where available.
EPA ToxValDB — Toxicity Values
2 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | ~6300 mg/kg | Guinea Pig | dermal | - | ECHA |
| LD50 | >2000 mg/kg | Rat | dermal | acute | ECHA |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
colorant
{"Common_Name": "Yellow Kaolin Clay", "Chemical_Name": "Iron oxide + kaolin", "CAS_Number": "Various", "Colorant_Type": "Natural Mineral", "Approved_Uses": "All cosmetics", "Max_Concentration_%": "No limit", "EU_Status": "Approved", "US_FDA_Status": "Approved", "Notes": "Yellow clay"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Abrasive
Absorbent
Anti-adhesive/cohesive
Anti-caking agent
Binder
Biocide
Conductive agent
Defoamer
Dye
Filler
Regulatory List Membership (3)
EU Regulated in Personal Care
EPA Safer Chemical Ingredients List (SCIL)
FDA Indirect Food Contact Additives
Expert Verdict
Expert safety assessment and concern-level summary for CI 77004 (Kaolin).
Regulatory Flags
natural-colorant
mineral-clay
eu-annex-iv
fda-delisted-1976
not-fda-standalone-colorant
gras-indirect-food
cir-safe-2023
kaolin
white-pigment
insoluble-mineral
matte-effect
epa_safer_alternative
Known Synonyms
Hydrated aluminum silicate
Altowhites
Arcilla blanca
Argilla alba
Bentone
BOL Blanc
Emathlite
Fitrol desiccite 25
Hydrite
Kaolin colloidal
Kaopaous
Kaophills-2
Langford
Light kaolin
Mcnamee
Parclay
Snow tex
White bole
beta Coat
EPA Pesticide Chemical Code 100104
Chemical Function
Filler
Abrasive
Surface modifier
Absorbent
Thickening agent
Regulatory Lists
active_ingredient; Europe; Pesticides
Canada; Personal care; Substances in PCP - Canada (4/2014)
Journal of Chemical Engineering & Process Technology
Food contact items
Indirect additives food contact (10/2018)
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
inert_ingredient; Pesticides
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
active_ingredient; Pesticides
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA count match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Adverse Event Associations
65
Frequently Asked Questions
Is CI 77004 (Kaolin) allowed in the EU?
CI 77004 (Kaolin) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 77004 (Kaolin) do in cosmetics?
CI 77004 (Kaolin) functions as: Colorant. Natural white clay mineral composed principally of aluminium silicates (kaolinite: Al2O3·2SiO2·2H2O); also known as China Clay, Pigment White 19, and Kaolin Clay. When used as a colorant in cosmetics it is declared as CI 77004; when used as an active ingredient (e.g., in OTC skin protectant or cleansing products) it is declared as KAOLIN. Imparts white opacity and matte finish to cosmetic products. Also functions as absorbent, bulking, and anticaking agent. Listed in EU Annex IV (Restriction IV/119). CIR assessed naturally-sourced clays including kaolin as safe in cosmetics (2023 Final Safety Assessment).. It is classified as a cosmetic ingredient in our database. CAS number: 1332-58-7.
Is CI 77004 (Kaolin) used outside cosmetics?
CI 77004 (Kaolin) 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 CI 77004 (Kaolin) 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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