Is Saccharin safe in cosmetics?
Saccharin has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 5 toxicological study endpoint(s) are available in our database.
Saccharin
Also known as: 1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, 1,1-Dioxo-1,2-dihydro-1lambda6-benzo[d]isothiazol-3-one, Benzosulfimide, O-, EINECS 201-321-0, RCRA waste number U202 (+15 more)
INCI: SACCHARIN
Saccharin (CAS 81-07-2) is a cosmetic cosmetic ingredient functioning as Flavouring; fragrance functional. NOAEL 353 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 81-07-2 →
Auto-generated CPSR Part A draft with source citations
Function
Flavouring; fragrance functional
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
1,1-dioxo-1,2-benzothiazol-3-one
InChIKey
CVHZOJJKTDOEJC-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
FDA Inactive Ingredients Database — approved for oral solutions, syrups, tablets, topical preparations; delisted from carcinogen list in 2000
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Saccharin.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
5 study endpoints found for Saccharin. 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 | =286 mg/kg bw/day | oral | Mouse | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =353 mg/kg bw/day | oral | Hamster | chronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =714 mg/kg bw/day | oral | Mouse | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =2000 mg/kg bw/day | injection | Mouse | developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =2500 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Saccharin 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 | =17000 mg/kg | Rat | oral | - | ECHA IUCLID |
| LD50 | >2000 mg/kg | Mouse | oral | - | ECHA IUCLID |
| LD50 | =17000 mg/kg | Mouse | oral | - | ECHA IUCLID |
| LD50 | >=8440 mg/kg | Rat | oral | - | ECHA IUCLID |
| LD50 | <=9710 mg/kg | Rat | oral | - | ECHA IUCLID |
| LOEL | =1000 mg/kg-day | Mouse | oral | chronic | ECHA IUCLID |
| NOAEL | =2000 mg/kg-day | Mouse | injection | - | ECHA IUCLID |
| NOAEL | =2000 mg/kg-day | Mouse | oral | - | ECHA IUCLID |
| NOAEL | =353 mg/kg-day | Hamster | oral | chronic | ECHA IUCLID |
| NOAEL | =286 mg/kg-day | Mouse | oral | - | ECHA IUCLID |
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
3
Volume
Sup 7, 73
Evaluation Year
1998
NB Overall evaluation downgraded to Group 3 with supporting evidence from other relevant data
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
25.55%
DPRA Lys %
-1.2%
KeratinoSens IC50
2000 µM
hCLAT CV75
1000 µg/mL
LLNA EC3
75%
NESIL
18750 µg/cm²
LLNA: NC (non-sensitizer)
GHS: not classified
Source: LLNA: Gerberick et al. (2005); DPRA: Natsch et al. 2013 [DOI:10.1002/jat.2868] | Nukada et al. 2013 [DOI:10.1016/j.tiv.2012.11.006]; KS: Natsch et al. 2013 [DOI:10.1002/jat.2868]; hCLAT: Ashikaga et al. 2010 [DOI:10.1177/026119291003800403]
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (2)
Carcinogen Classification
Saccharin and its salts | Group 3: Not classifiable as to its carcinogenicity to humans | Volume Sup 7: Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42, 1987; 440 pages; ISBN 92-832-1411-0 (out of print) | Volume 73: (1999) Some Chemicals that Cause Tumours of the Kidney or Urinary Bladder in Rodents and Some Other Substances | NB Overall evaluation downgrade
Source: International Agency for Research on Cancer (IARC)
Evidence for Carcinogenicity
Evaluation: There is inadequate evidence in humans for the carcinogenicity of saccharin salts used as sweeteners. There is sufficient evidence in experimental animals for the carcinogenicity of sodium saccharin. There is inadequate evidence in experimental animals for the carcinogenicity of saccharin (acid form) and calcium saccharin. Overall evaluation: In making the evaluation, the Working Group
Source: Hazardous Substances Data Bank (HSDB)
Regulatory (2)
JECFA Evaluation
SACCHARIN | 1993 | 0-5 mg/kg bw | GROUP ADI FOR SACCHARIN AND ITS CALCIUM, POTASSIUM AND SODIUM SALTS | TRS 837-JECFA 41/17 | FAS 32-JECFA 41/105
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
SOLUBLE SACCHARIN | 1993 | 0-5 mg/kg bw | GROUP ADI FOR SACCHARIN AND ITS CALCIUM, POTASSIUM AND SODIUM SALTS | TRS 837-JECFA 41/17 | FAS 32-JECFA 41/105
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Deodorizer
Flavouring and nutrient
Fragrance
Regulatory List Membership (2)
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Saccharin.
Regulatory Flags
fragrance-component
ifra_fragrance
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Saccharin by CAS number or substance name.
Studies
5
Lowest NOAEL
286 mg/kg bw/day
Highest NOAEL
2500 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide
1,1-Dioxo-1,2-dihydro-1lambda6-benzo[d]isothiazol-3-one
Benzosulfimide, O-
EINECS 201-321-0
RCRA waste number U202
Saccharina
Sulfobenzimide, O-
NSC 5731
UNII-FST467XS7D
1, 2-Benzisothiazol-3(2H)-one, 1,1-dioxide
1, 2-Benzisothiazolin-3-one 1,1-dioxide
1, 2-Dihydro-2-ketobenzisosulfonazole
1,1-Diox-1,2-benzisothiazol-3-one
1,1-Dioxide-1,2-benzisothiazol-3(2H)-one
1,1-Dioxide-1,2-benzisothiazolin-3-one
1,1-Dioxo-1,2-dihydro-1lambda*6*-benzo[D]isothiazol-3-one
1,1-Dioxo-1,2-dihydro-benzo[d]isothiazol-3-one
1,2-Benzisothiazol-3(2H)-one 1,1-dioxide
1,2-Benzisothiazol-3(2H)-one 1,1-dioxide, 9CI
1,2-Benzisothiazolin-3-one 1,1-dioxide
Chemical Function
Deodorizer
Flavouring and nutrient
Fragrance
Regulatory Lists
inert_ingredient; non_food_use; Pesticides
animal_products
IFRA Transparency
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; pharmaceutical
detected; MN Chemical Screening; surface_water
Canada; consumer_product; Substances in Products - Canada (4/2014)
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
SACCHARIN
ChEMBL ID
CHEMBL310671
Max Phase
3
Frequently Asked Questions
Is Saccharin allowed in the EU?
Saccharin EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Saccharin do in cosmetics?
Saccharin functions as: Flavouring; fragrance functional. It is classified as a cosmetic ingredient in our database. CAS number: 81-07-2.
What is the NOAEL for Saccharin?
The NOAEL (No Observed Adverse Effect Level) for Saccharin is =286 mg/kg bw/day based on a reproduction developmental study via oral route in Mouse. A total of 5 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.
Is Saccharin used outside cosmetics?
Saccharin 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 Saccharin 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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