Is Sucralose safe in cosmetics?
Sucralose has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Sucralose
Also known as: Predillon SU 600, 4,1',6'-Trichloro-4,1',6'-trideoxygalactosucrose, Sansweet SU 100, Splenda, α-D-Galactopyranoside, 1,6-dichloro-1,6-dideoxy-β-D-fructofuranosyl 4-chloro-4-deoxy- (+14 more)
INCI: SUCRALOSE
Sucralose (CAS 56038-13-2) is a cosmetic cosmetic ingredient functioning as Sweetening agent. NOAEL 250 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max 1%. 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 56038-13-2 →
Function
Sweetening agent
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
EU Max Conc.
1%
US US Status
permitted
US Notes
FDA approved sweetening agent for cosmetic use
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Sucralose.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Sucralose. 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 | 119 mg/kg bw/day | oral | rat | Developmental | COSMOS DB |
| NOAEL | 150 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS DB |
| NOAEL | 233 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS DB |
| NOAEL | 296 mg/kg bw/day | oral | dog | Chronic | COSMOS DB |
| NOAEL | 500 mg/kg bw/day | oral | rat | Special Toxicology Study | COSMOS DB |
| NOAEL | 700 mg/kg bw/day | oral | rabbit | Developmental | COSMOS DB |
| NOAEL | 750 mg/kg bw/day | oral | rabbit | Developmental | COSMOS DB |
| NOAEL | 1500 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS DB |
| NOAEL | 2000 mg/kg bw/day | oral | rat | Subchronic | COSMOS DB |
| NOAEL | 2500 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS DB |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Sucralose across SCCS product categories, with measured dermal absorption where available.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >10000 mg/kg | Rat | oral | - | ECHA |
| LD50 | >16000 mg/kg | Mouse | oral | - | ECHA |
| LOAEL | >=30000 ppm | Rat | oral | - | ECHA |
| LOAEL | >=3000 ppm | Rat | oral | - | ECHA |
| LOAEL | >=10000 ppm | Rat | oral | - | ECHA |
| LOAEL | >=3000 ppm | Rat | oral | - | ECHA |
| LOAEL | >=3000 ppm | Rat | oral | - | ECHA |
| LOEL | ~750 mg/kg-day | Rat | oral | chronic | ECHA |
| LOEL | <=3000 mg/kg-day | Rat | oral | chronic | ECHA |
| NOAEL | >2340 mg/kg-day | Rat | oral | - | ECHA |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Flavouring and nutrient
Fragrance
Softener and conditioner
Regulatory List Membership (2)
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
Editorial summary
Preliminary editorial summary for Sucralose — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
ifra_fragrance
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Sucralose by CAS number or substance name.
Studies
14
Lowest NOAEL
119 mg/kg bw/day
Highest NOAEL
5000 mg/kg bw/day
COSMOS DB
Known Synonyms
Predillon SU 600
4,1',6'-Trichloro-4,1',6'-trideoxygalactosucrose
Sansweet SU 100
Splenda
α-D-Galactopyranoside, 1,6-dichloro-1,6-dideoxy-β-D-fructofuranosyl 4-chloro-4-deoxy-
1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl 4-chloro-4-deoxy-α-D-galactopyranoside
1',4,6'-Trichlorogalactosucrose
San Sweet SA 8020
Sansweet SU 200
Sucrazit
1,6-dichloro-1,6-dideoxy-β-D-fructofuranosyl 4-chloro-4-deoxy-α-D-galactose
EC No.: 259-952-2
BRN 3654410
EINECS 259-952-2
4,1',6'-Trichloro-4,1',6'-trideoxy-galacto-sucrose
Trichlorogalacto-sucrose
Trichlorogalactosucrose
UNII-96K6UQ3ZD4
TGS
Chemical Function
Softener and conditioner
Flavouring and nutrient
Fragrance
Regulatory Lists
Canada; consumer_product; Substances in Products - Canada (4/2014)
IFRA Transparency
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Europe; Personal care - oral and dental care - teeth whitener
Australian Status
AICIS status: listed_with_terms
Specific information requirements: Obligations to provide information apply. You must tell us within 28 days if the circumstances of your importation or manufacture (introduction) are different to those in our assessment.
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
SUCRALOSE
ChEMBL ID
CHEMBL3185084
Max Phase
3
Adverse Event Associations
9
Frequently Asked Questions
Is Sucralose allowed in the EU?
Sucralose EU regulatory status: permitted. Maximum allowed concentration: 1%. This is based on EU Regulation 1223/2009 and its amendments.
What does Sucralose do in cosmetics?
Sucralose functions as: Sweetening agent. It is classified as a cosmetic ingredient in our database. CAS number: 56038-13-2.
What is the NOAEL for Sucralose?
The NOAEL (No Observed Adverse Effect Level) for Sucralose is 119 mg/kg bw/day based on a Developmental study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS DB.
Is Sucralose used outside cosmetics?
Sucralose 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 Sucralose 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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