Is Glutaral safe in cosmetics?
Glutaral has a safety rating of "POOR" in our database. EU status: restricted. US status: restricted. 10 toxicological study endpoint(s) are available in our database.
Glutaral
Also known as: Glutaric dialdehyde, Pentanedial, 4-01-00-03659, Aldesen, Alhydex (+12 more)
INCI: GLUTARAL
Glutaral (CAS 111-30-8) is a cosmetic cosmetic ingredient functioning as Preservative, Fragrance. Reported NOAEL =50 mg/kg/day in rat (CIR Safety Assessment); EU Regulation 1223/2009 status: restricted, max 0.1%; GHS signal word DANGER. 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.
View industrial chemical safety profile for CAS 111-30-8 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Glutaral is classified GHS Danger (H301, H314, H317, H318, H330, H331, H334, H335) in the chemicals database but is restricted in EU cosmetics at max 0.1%.
Source: Cosmetics: ingredients.eu status/eu max; Chemicals: ghs classifications.signal word/hazard statement code
Function
Preservative, Fragrance
Safety Rating
POOR
Chemistry & Identifiers
IUPAC Name
pentanedial
InChIKey
SXRSQZLOMIGNAQ-UHFFFAOYSA-N
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.1%
US US Status
restricted
US Notes
CIR 1996/2011: safe at 0.5% or less in rinse-off products; unsafe in aerosols; leave-on use restricted to impurity level of 0.000006% or less.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Glutaral.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Glutaral. 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 | =50 mg/kg/day | inhalation | rat | repeated dose toxicity | CIR Safety Assessment |
| NOAEL | =50 mg/kg/day | inhalation | rat | repeated dose toxicity | CIR Safety Assessment |
| NOAEL | =50 mg/kg/day | inhalation | rat | repeated dose toxicity | CIR Safety Assessment |
| NOAEL | =50 mg/kg/day | inhalation | rat | repeated dose toxicity | CIR Safety Assessment |
| NOAEL | 9 mg/kg bw/day | oral | dog | Subchronic | COSMOS DB |
| NOAEL | 13.5 mg/kg bw/day | oral | dog | Short Term Toxicity | COSMOS DB |
| NOAEL | =50 mg/kg bw/day | - | Rat | Carcinogenicity | WHO/JECFA |
| NOAEL | =5 mg/kg bw/day | oral | Rat | subchronic | ECHA |
| NOAEL | =7 mg/kg bw/day | oral | Rat | subchronic | ECHA |
| NOAEL | =12.8 mg/kg bw/day | oral | Rat | short-term | ECHA |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Signal Word
DANGER
Pictograms
SkullToxicCancerHealth hazEnviroAqua
Hazard Statements
Toxic if swallowed, in contact with skin or if inhaled Causes skin and eye irritation May cause an allergic skin reaction May cause allergy or asthma symptoms or breathing difficulties if inhaled May cause respiratory irritation Very toxic to aquatic life
Short-term Exposure Effects
The substance is irritating to the eyes, skin and respiratory tract.
Long-term Exposure Effects
Repeated or prolonged contact with skin may cause dermatitis. Repeated or prolonged contact may cause skin sensitization. Repeated or prolonged inhalation may cause asthma. See Notes.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its vapour, through the skin and by ingestion.
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Acute ToxicityCorrosiveHealth HazardEnvironmental Hazard
Hazard Class and Category
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1A; Aquatic Acute 1; Aquatic Chronic 2
Hazard Statements
- H330 Fatal if inhaled
- H301 Toxic if swallowed
- H335 May cause respiratory irritation
- H314 Causes severe skin burns and eye damage
- H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled
- H317 May cause an allergic skin reaction
- H400 Very toxic to aquatic life
- H411 Toxic to aquatic life with long lasting effects
Specific Concentration Limits / M-factors
STOT SE 3; H335: 0.5% ≤ C < 5.0%; M = 1
Inserted via ATP: ATP09
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
27.7%
DPRA Lys %
84.8%
KeratinoSens IC50
242.56 µM
hCLAT CV75
5.3 µg/mL
LLNA EC3
0.07%
NESIL
70 µg/cm²
LLNA: Strong (1A)
GHS: 1A
Human: positive
Source: LLNA: Griem et al. (2003) | Basketter et al (2001); DPRA: Gerberick et al. 2004 [DOI:10.1093/toxsci/kfh213] | Nukada et al. 2013 [DOI:10.1016/j.tiv.2012.11.006]; KS: Emter et al. 2010 [DOI:10.1016/j.taap.2010.03.009]; hCLAT: Ashikaga et al. 2010 [DOI:10.1177/026119291003800403]; HPPT: [30] Marzulli FN and Maibach HI (1974): https://doi.org/10.1016/0015-6264(74)90367-8
HRIPT Human Patch Test Studies
3 human repeat insult patch tests aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HRIPT | - | 0 | 69.75 | - | - |
| HRIPT | - | 0 | 3487.51 | - | - |
| OECD_DA_Human | - | 0 | - | - | 1A (Strong sensitizer) |
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Cosmetic-Specific Mechanism
Category: preservative
Receptor targets: ERα (weak, limited)
LOEC: N/A
EU status: restricted (max 0.1%); sensitizer
weak modulator
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
Yes (since 08-Jul-2021)
Hazard classification: Restricted (Annex XVII)
SVHC reason: Respiratory sensitising properties (Article 57(f) - human health)
Substance of Very High Concern (SVHC)
Included: 08-Jul-2021
Respiratory sensitising properties (Article 57(f) - human health)
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex V — Permitted Preservatives
Max: 0.1%
Contains glutaral (9)
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
KR Korea MFDS Annex 2 (Restricted)
Category: Preservative. Max: 0.1%. Aerosol products prohibited
SA Saudi SFDA (V - Preservatives)
Max: 0.001. Contains glutaral (9)
BRIN Brazil/India Cosmetics
Brazil: Permitted Preservative · max 0,1%
India: Permitted Preservative · max 0.001
Additional Jurisdictional Restrictions (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| IN | permitted_preservative | 0.1 | all cosmetics |
| BR | permitted_preservative | 0.1 | Prohibited in sprayable systems; only for concentrations >0.05% in finished product |
| ASEAN | permitted_preservative | 0.1% | All products |
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (7)
Carcinogen Classification
No indication of carcinogenicity to humans (not listed by IARC).
Source: Toxin and Toxin Target Database (T3DB)
Carcinogen Classification
Glutaraldehyde | TR-490: Toxicology and Carcinogenesis Studies of Glutaraldehyde (CASRN 111-30-8) in F344/N Rats and B6C3F1 Mice (Inhalation Studies) (1999 ) | 10/30/98 | No Evidence | No Evidence | No Evidence | No Evidence | Under the conditions of these 2-year inhalation studies, there was no evidence of carcinogenic activity of glutaraldehyde in male or female F344/N rats exposed to 2
Source: NTP Technical Reports
Evidence for Carcinogenicity
A4; Not classifiable as a human carcinogen. /Glutaraldehyde/
Source: Hazardous Substances Data Bank (HSDB)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
ICSC Safety Card
0158
Source: WHO/JECFA
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Flavouring and nutrient
Fragrance
Oxidizing agent
Preservative
Processing aids not otherwise specified
Regulatory List Membership (3)
EU Regulated in Personal Care
FDA Substances Added to Food (EAFUS)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Glutaral.
Regulatory Flags
sensitizer
restricted
annex-v
aerosol-prohibited
legacy-preservative
occupational-hazard
labeling-required
not-cosmos-approved
fda_food_additive
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Glutaral by CAS number or substance name.
Studies
22
Lowest NOAEL
5
Highest NOAEL
1020
Units vary across source rows: mg/kg bw/day, mg/kg/day
ECHA
COSMOS DB
CIR Safety Assessment
WHO/JECFA
Known Synonyms
Glutaric dialdehyde
Pentanedial
4-01-00-03659
Aldesen
Alhydex
BRN 0605390
Caswell No. 468
1,3-Diformylpropane
EINECS 203-856-5
EPA Pesticide Chemical Code 043901
Glutaric aldehyde
Glutarol
NCI-C55425
Aldehyd glutarowy
Glutaralum
UNII-T3C89M417N
1,5-Pentanedione
Chemical Function
Preservative
Biocide
Fragrance
Flavouring and nutrient
Regulatory Lists
pharmaceutical
active_ingredient; Europe; Pesticides
Europe; Other direct contact consumer goods; residue
Canada; pharmaceutical
Cleaning products and household care - dishwasher and dishes - automatic dishwashing detergent; Europe
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
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
Australian Status
AICIS status: listed_with_terms
Specific information requirements: Obligations to provide information apply. These obligations are: 1. If the assessment report about the chemical recommends secondary notification of the chemical in particular circumstances and any of the circumstances occur in relation to the introduction (importation or manufacture) of the chemical by a person, then the...
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
GLUTARAL
ChEMBL ID
CHEMBL1235482
Max Phase
2
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
GLUTARALDEHYDE
Food Category
food_additive
Frequently Asked Questions
Is Glutaral allowed in the EU?
Glutaral EU regulatory status: restricted. Maximum allowed concentration: 0.1%. This is based on EU Regulation 1223/2009 and its amendments.
What does Glutaral do in cosmetics?
Glutaral functions as: Preservative, Fragrance. It is classified as a cosmetic ingredient in our database. CAS number: 111-30-8.
What is the NOAEL for Glutaral?
The NOAEL (No Observed Adverse Effect Level) for Glutaral is =50 mg/kg/day based on a repeated dose toxicity study via inhalation route in rat. A total of 10 study endpoints are available. Source: CIR Safety Assessment.
Is Glutaral classified as hazardous under GHS?
Glutaral carries a GHS signal word of "DANGER". Hazard statements: Toxic if swallowed, in contact with skin or if inhaled Causes skin and eye irritation May cause an allergic skin reaction May cause allergy or asthma symptoms or breathing difficulties if inhaled May cause respiratory irritation Very toxic to aquatic life. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.
Is Glutaral used outside cosmetics?
Glutaral 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.
Does Glutaral have different safety status in cosmetics vs industrial chemicals?
Glutaral is classified GHS Danger (H301, H314, H317, H318, H330, H331, H334, H335) in the chemicals database but is restricted in EU cosmetics at max 0.1%.
Compliance Tools
Check Glutaral compliance across multiple jurisdictions:
Ingredient Decoder
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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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