Poor Cosmetic Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed Sensitization Data

Glyoxal

Also known as: Ethanedial, 4-01-00-03625, Aerotex glyoxal 40, BRN 1732463, EINECS 203-474-9 (+4 more)

INCI: GLYOXAL

Glyoxal (CAS 107-22-2) is a cosmetic cosmetic ingredient functioning as Preservative (formaldehyde releaser). NOAEL 100 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 0.05%; 1 safety opinion reviewed (cir). 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 107-22-2 →

Auto-generated CPSR Part A draft with source citations
Function
Preservative (formaldehyde releaser)
Safety Rating
POOR

Chemistry & Identifiers

Formula
C2H2O2
MW
58.04 g/mol
EC Number
203-474-9
PubChem CID
7860
IUPAC Name
oxaldehyde
InChIKey
LEQAOMBKQFMDFZ-UHFFFAOYSA-N

Regulatory Status

EU EU Status restricted
EU Max Conc. 0.05%
US US Status restricted
US Notes Restricted / pending ban — FDA identified glyoxal as a formaldehyde releaser. US proposed rule under MoCRA to ban formaldehyde and formaldehyde releasers in cosmetics

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Glyoxal. 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 =100 mg/kg/day oral rat oral toxicity CIR_vision_codex
NOAEL =100 mg/kg/day oral rat oral toxicity CIR_vision_codex
NOAEL =100 mg/kg/day oral rat oral toxicity CIR_vision_codex
NOAEL =100 mg/kg/day oral rat oral toxicity CIR_vision_codex
NOAEL =25 mg/kg bw - - Chronic toxicity INCHEM_WHO_cicads_cicads_cicad57
NOAEL =25 mg/kg bw - - Chronic toxicity INCHEM_WHO_cicads_cicads_cicad57
NOAEL =125 mg/kg bw/day oral Rat Subchronic toxicity INCHEM_WHO_cicads_cicads_cicad57
NOAEL =125 mg/kg bw - Rat Toxicology study INCHEM_WHO_cicads_cicads_cicad57
NOAEL =125 mg/kg bw - Rat Toxicology study INCHEM_WHO_cicads_cicads_cicad57
NOAEL =5 mg/kg bw oral rat NOAEL study SCCS_vision_codex

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Short-term Exposure Effects
The substance is irritating to the eyes and skin.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol or vapour and by ingestion.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir
Verdict: safe
NOAEL: 300 mg/kg/day (oral)

to limit the concentration of free formaldehyde, the Expert Panel concluded that Glyoxal is safe for use in products intended to be applied to the nail at concentrations < 1.25%. The available data are insufficient to support the safety for other uses, if any. INTRODUCTION Glyoxal (CAS No. 1

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Glyoxal across SCCS product categories, with measured dermal absorption where available.

Sensitization Profile

Contact sensitization data for Glyoxal based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.3%
Cross-reactivity Group
aldehyde-group
Reaction Type
contact-dermatitis

Source: ESSCA; IVDK; NACDG

EU CLP Annex VI Harmonized Classification

Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.

Signal Word
Warning
Pictograms
Health HazardHarmful / Irritant
Hazard Class and Category
Muta. 2; Acute Tox. 4 *; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
Hazard Statements
  • H341 Suspected of causing genetic defects
  • H332 Harmful if inhaled
  • H315 Causes skin irritation
  • H319 Causes serious eye irritation
  • H317 May cause an allergic skin reaction
Specific Concentration Limits / M-factors
*

Inserted via ATP: CLP00

Sensitization AOP Dashboard

Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.

DPRA Cys %
62.35%
DPRA Lys %
47.25%
KeratinoSens IC50
693.99 µM
hCLAT CV75
396 µg/mL
LLNA EC3
1%
NESIL
6207 µg/cm²
LLNA: Strong (1A) GHS: 1A Human: positive

Source: LLNA: Gerberick et al. (2005) | Schneider & Akkan (2004); DPRA: Gerberick et al. 2007 [DOI:10.1093/toxsci/kfm064] | Nukada personal communication (undated); KS: Natsch et al. 2013 [DOI:10.1002/jat.2868] | Natsch et al. 2011 [DOI:10.1021/tx2003678]; hCLAT: Ashikaga et al. 2010 [DOI:10.1177/026119291003800403]; HPPT: [27] Kligman AM (1966): https://doi.org/10.1038/jid.1966.160

HRIPT Human Patch Test Studies

2 human repeat insult patch tests aggregated from dermatological literature.

Test Type N Sensitized Dose µg/cm² NESIL µg/cm² Potency
HMT - 0 6206.9 - -
OECD_DA_Human - 0 - - 1A (Strong sensitizer)

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
10,000 - 100,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)

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.

SA Saudi SFDA (III - Restricted)
Max: 100 mg/kg.
BRIN Brazil/India Cosmetics
Brazil: Restricted · max 100 mg/kg
India: Restricted · max 100 mg/kg
Additional Jurisdictional Restrictions (2)
Jurisdiction Status Max % Product Type
BR restricted 0.01 As impurity/trace only; max 100 mg/kg (0.01%)
ASEAN restricted 100 mg/kg All products

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Aggregated DA Values (1 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured 100.0% in_vitro - SCCP/0023

Additional Ingredient Properties

1 property record from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "preservative", "cross_reactivity_group": "aldehyde-group", "patch_test_frequency_pct": "0.3", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA; IVDK; NACDG"}

PubChem Annotations

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

Safety (3)
Evidence for Carcinogenicity
A4: Not classifiable as a human carcinogen.
Source: Hazardous Substances Data Bank (HSDB)
ICSC Safety Card
1162
Source: ILO-WHO International Chemical Safety Cards (ICSCs)
Skin Eye Respiratory Irritation
Liquid /is/ irritating to skin and eyes. | Inhalation causes some irritation of nose and, 40% solution throat.
Source: Hazardous Substances Data Bank (HSDB)

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Biocide Chemical reaction regulator Film former Fragrance Preservative
Regulatory List Membership (2)
FDA Indirect Food Contact Additives EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Glyoxal.

Regulatory Flags

potential-allergen preservative eu_cosing_listed

NOAEL Studies Summary

View details ->

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

Studies
55
Lowest NOAEL
5
Highest NOAEL
1000

Units vary across source rows: mg/kg bw/day, mg/kg bw, mg/kg/day

ToxValDB_ECHA_IUCLID INCHEM_WHO_cicads_cicads_cicad57 CIR_vision_codex SCCS_vision_codex

Dermal Absorption

View details ->
Absorption % Method Vehicle
100.0% in_vitro -

Known Synonyms

Ethanedial 4-01-00-03625 Aerotex glyoxal 40 BRN 1732463 EINECS 203-474-9 UNII-50NP6JJ975 Diformal ethane-1,2-dial oxal

Chemical Function

Fragrance Biocide Preservative Chemical reaction regulator Film former

Regulatory Lists

inert_ingredient; non_food_use; Pesticides active_ingredient; Europe; Pesticides Indirect additives food contact (10/2018) active_ingredient; Europe; Pesticides Europe; Personal care; restricted

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.

ChEMBL ID
CHEMBL1606435
View full pharmaceutical profile →

Frequently Asked Questions

Is Glyoxal safe in cosmetics?

Glyoxal 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. This ingredient has been reviewed by cir.

Is Glyoxal allowed in the EU?

Glyoxal EU regulatory status: restricted. Maximum allowed concentration: 0.05%. This is based on EU Regulation 1223/2009 and its amendments.

What does Glyoxal do in cosmetics?

Glyoxal functions as: Preservative (formaldehyde releaser). It is classified as a cosmetic ingredient in our database. CAS number: 107-22-2.

What is the NOAEL for Glyoxal?

The NOAEL (No Observed Adverse Effect Level) for Glyoxal is =100 mg/kg/day based on a oral toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: CIR_vision_codex.

Is Glyoxal used outside cosmetics?

Glyoxal 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.

Does Glyoxal have different safety status in cosmetics vs industrial chemicals?

Glyoxal is classified GHS Danger (H302, H332, H315, H317, H319, H334, H335, H341) in the chemicals database but is restricted in EU cosmetics at max 0.05%.

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