Also known as: D-Glucitol, 4-O-alpha-D-glucopyranosyl-, Amalty, Lesys, Lycasin HBC, Mabit (+15 more)
INCI: MALTITOL
Maltitol (CAS 585-88-6) is a cosmetic cosmetic ingredient functioning as Humectant, masking agent, moisturising. Reported NOAEL =7600 mg/kg bw/day in Rat (EFSA); EU Regulation 1223/2009 status: permitted; 2 safety opinions reviewed (CIR Safety Assessment). 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.
US NotesAllowed; also approved as a food additive (sugar alcohol), further supporting its safe topical profile.
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Maltitol.
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Toxicological Studies
4 study endpoints found for Maltitol. 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
=7600 mg/kg bw/day
oral: feed
Rat
subchronic
EFSA
NOAEL
=7600 mg/kg bw/day
oral: feed
Rat
subchronic
EFSA
NOAEL
=15400 mg/kg bw/day
oral: feed
Rat
subchronic
EFSA
NOAEL
=15400 mg/kg bw/day
oral: feed
Rat
subchronic
EFSA
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
CIR Safety AssessmentSeptember 23, 2008
Verdict: safe
NOAEL: 4.5 g commercial product/kg bw/day (not specified)
ty test data were available for Maltitol Laurate, the Panel concluded that the safety Maltitol Laurate may be inferred based on the available data for Maltitol and for Lauric Acid, the two hydrolysis products of Maltitol Laurate (a previous safety assessment of Lauric Acid completed
CIR Safety AssessmentSeptember 23, 2008
Verdict: safe
NOAEL: 4.5 g commercial
product/kg bw/day (not specified)
ty test data were available for Maltitol Laurate, the Panel concluded that the safety Maltitol Laurate may be inferred based on the available data for Maltitol and for Lauric Acid, the two hydrolysis products of Maltitol Laurate (a previous safety assessment of Lauric Acid completed
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1 - 10 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Public NOAEL study rows linked to Maltitol by CAS number or substance name.
Studies
4
Lowest NOAEL
7600 mg/kg bw/day
Highest NOAEL
1.540e+4 mg/kg bw/day
EFSA
Known Synonyms
D-Glucitol, 4-O-alpha-D-glucopyranosyl-AmaltyLesysLycasin HBCMabitMabit 50MMalti-MR 100MaltidexMaltidex CH 16385Maltidex M 16313Maltilite 5575Maltilite 7575Maltilite P 200MaltilolMaltisorb 75/77MaltitMaltitol G 3Sweet G 2SweetPearlSweetPearl P 200
Chemical Function
HumectantDeodorizerSoftener and conditionerFlavouring and nutrientPharmaceutical excipient
Regulatory Lists
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 and food safety data.
SOURCEChEMBL / DrugCentral / FAERSDB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Maltitol has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted. 4 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by CIR Safety Assessment.
Is Maltitol allowed in the EU?
Maltitol EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Maltitol do in cosmetics?
Maltitol functions as: Humectant, masking agent, moisturising. It is classified as a cosmetic ingredient in our database. CAS number: 585-88-6.
What is the NOAEL for Maltitol?
The NOAEL (No Observed Adverse Effect Level) for Maltitol is =7600 mg/kg bw/day based on a subchronic study via oral: feed route in Rat. A total of 4 study endpoints are available. Source: EFSA.
Is Maltitol used outside cosmetics?
Maltitol 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.
Compliance Tools
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