Moderate Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed

Maltitol

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 and food safety data.

View industrial chemical safety profile for CAS 585-88-6 →

Auto-generated CPSR Part A draft with source citations
Function
Humectant, masking agent, moisturising
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C12H24O11
MW
344.31 g/mol
EC Number
209-567-0
PubChem CID
493591
IUPAC Name
(2S,3R,4R,5R)-4-[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexane-1,2,3,5,6-pentol
InChIKey
VQHSOMBJVWLPSR-WUJBLJFYSA-N

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes Allowed; also approved as a food additive (sugar alcohol), further supporting its safe topical profile.

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Maltitol.

Calculate MoS for your specific formulation with the MoS Calculator.

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 Assessment September 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 Assessment September 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

Additional Ingredient Properties

8 property records from structured ingredient metadata.

acne
{"cas_number": "585-88-6", "anti_acne_mechanism": "anti_inflammatory", "comedogenicity_rating_0_to_5": "0-1", "acne_type_efficacy": "inflammatory", "sebum_reduction_pct_clinical": "0-5", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentration_pct": "No limit", "japan_quasi_drug_anti_acne": "No", "korea_functional_cosmetic_acne": "No", "eu_cosmetic_restriction…
baby_pediatric
{"cas_number": "585-88-6", "ingredient_class": "moisturizer_baby", "pediatric_safety_rating": "excellent", "minimum_age_months": "0", "neonatal_safe": "yes", "premature_infant_safe": "yes", "skin_barrier_maturity_consideration": "Sugar alcohol, GRAS", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern": "Humectant penet…
comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "0", "skin_type_suitability": "all,oily,dry,combination,normal", "acne_safe": "yes", "source": "Humectant"}
humectant
{"cas_number": "585-88-6", "ingredient_class": "humectant/polyol/sugar_derivative", "molecular_weight_Da": "344.31", "chemical_type": "polyol", "water_binding_mechanism": "hydrogen_bonding/hygroscopic", "water_holding_capacity_g_per_g": "0.5-0.7", "hygroscopicity_at_50_RH": "good", "hygroscopicity_at_80_RH": "excellent", "NMF_component": "no", "NMF_percentage_natural": "0", "TEWL_reduction_pct": "…
ph_stability
{"optimal_ph_min": "3.0", "optimal_ph_max": "10.0", "stable_ph_min": "3.0", "stable_ph_max": "11.0", "ph_dependent_function": "Sugar alcohol humectant", "formulation_note": "Disaccharide alcohol", "source": "Formulation literature"}
skin_suitability
{"oily_skin": "acceptable", "dry_skin": "recommended", "sensitive_skin": "acceptable", "combination_skin": "acceptable", "normal_skin": "recommended", "acne_prone": "acceptable", "rosacea": "acceptable", "eczema": "acceptable", "hyperpigmentation": "acceptable", "aging_mature": "acceptable", "dehydrated": "recommended", "skin_benefit_primary": "humectant", "skin_benefit_secondary": "texture-enhanc…
solubility_hlb
{"water_soluble": "yes", "oil_soluble": "no", "soluble_in": "water, glycerin", "insoluble_in": "oils, ethanol, silicones", "log_p": "-3.5", "melting_point_c": "148-151", "appearance": "white powder", "source": "Roquette"}
uv_stability
{"uv_stable": "yes", "uv_degradation_rate": "stable", "photosensitizer": "no", "phototoxic": "no", "photoallergic": "no", "requires_uv_protection_packaging": "no", "color_change_uv": "no", "odor_change_uv": "no", "efficacy_loss_uv_pct": "0", "spf_contribution": "no", "uva_protection": "no", "uvb_protection": "no", "photostable_sunscreen": "no", "boost_spf_of_others": "no", "antioxidant_under_uv": …

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Regulatory (4)
JECFA Evaluation
DRIED MALTITOL SYRUP | 1997 | NOT SPECIFIED | TRS 884-JECFA 49/21 | FAS 40-JECFA 49/103
Source: WHO/JECFA
JECFA Evaluation
HYDROGENATED MALTOSE | 1993 | NOT SPECIFIED | TRS 837-JECFA 41/16 | FAS 32-JECFA 41/101
Source: WHO/JECFA
JECFA Evaluation
HYDROGENATED HIGH MALTOSE-CONTENT GLUCOSE SYRUP | 1997 | NOT SPECIFIED | TRS 884-JECFA 49/21 | FAS 40-JECFA 49/103
Source: WHO/JECFA
EU Food Improvement
Food additives
Source: EU Food Improvement Agents

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Deodorizer Flavouring and nutrient Humectant Pharmaceutical excipient Softener and conditioner

Expert Verdict

Expert safety assessment and concern-level summary for Maltitol.

Regulatory Flags

potential-allergen jecfa_safe

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Maltitol by CAS number or substance name.

Studies
4
Lowest NOAEL
7600 mg/kg bw/day
Highest NOAEL
15400 mg/kg bw/day
EFSA

Known Synonyms

D-Glucitol, 4-O-alpha-D-glucopyranosyl- Amalty Lesys Lycasin HBC Mabit Mabit 50M Malti-MR 100 Maltidex Maltidex CH 16385 Maltidex M 16313 Maltilite 5575 Maltilite 7575 Maltilite P 200 Maltilol Maltisorb 75/77 Maltit Maltitol G 3 Sweet G 2 SweetPearl SweetPearl P 200

Chemical Function

Humectant Deodorizer Softener and conditioner Flavouring and nutrient Pharmaceutical 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 food safety data.

SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
Maltitol
E Number
E965(i)
ADI
NOT SPECIFIED mg/kg bw
Food Category
sweetener
View full food safety profile →

Frequently Asked Questions

Is Maltitol safe in cosmetics?

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 and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Is Maltitol in Your Products?

Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free →

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Maltitol in your formulation.