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Ingredients

Ingredient Dictionary

GLUTARAL

Glutaraldehyde is a dialdehyde comprised of pentane with aldehyde functions at C-1 and C-5.

Korean limit
0.1%
Molecular structure

Definition

US FDA substance register · UNII T3C89M417N · registered name GLUTARAL · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

Glutaral is the dialdehyde that conforms to the formula:

Glutaraldehyde is a dialdehyde comprised of pentane with aldehyde functions at C-1 and C-5. It has a role as a disinfectant, a cross-linking reagent and a fixative.

Source: PubChem

Cosmetic roles

Stops microbes growing in the productPRESERVATIVEListed as a fragrance-composition material (not a claim that it adds scent)FRAGRANCE

Safety & regulatory references

Allowed preservative
United Kingdom

Source: ASEAN Cosmetic Directive · EU Cosmetics Regulation · Taiwan FDA cosmetic ingredients · UK cosmetics regulations (OPSS)

Argentina · Brazil

  • Maximum concentration permitted at final product : 0.1%
  • Other limitations and requirements : Banned in sprayable systems such as aerosols and sprays
  • Use conditions and warnings that must appear on the label : Contains glutaraldehyde (for concentrations greater than 0.05% in the finished product only)

ASEAN

  • Maximum authorised concentration in the finished cosmetic product : 0.1%
  • Other limitations and requirements : Prohibited in aerosols (sprays)
  • Conditions of use and warning which must be printed on the labels : - Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.05%)

Taiwan

  • Maximum concentration : 0.1%
  • 0.1%

China · South Korea

  • Maximum concentration : 0.1%

European Union

  • Maximum concentration in ready for use preparation : 0.1%
  • Other : Not to be used in aerosols (sprays)
  • Wording of conditions of use and warnings : Contains glutaral (9)

Source: MFDS (Korea) cosmetic regulatory information

Korea’s toxic-substance GHS classification: Danger · H411 (category 2) · H301 (category 3) · H317 (category 1A) · +5 more

Source: Korea toxic substances GHS register (NIER)

EU Cosmetics Regulation, Annex V (allowed preservatives), entry 48 · maximum concentration 0.1%

Source: EU allowed preservatives (Annex V)

Restriction V/48 · Other restriction: ban substances that deplete the ozone layer

Source: EU CosIng ingredient list

Reviewed by CIR: Final Report on the Safety Assessment of Glutaral

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: 40th Anniversary Overview and Rereview Summaries From 2011 to 2015

Source: US Cosmetic Ingredient Review (CIR)

More data — names, identifiers, properties, test records, literature

Names & identifiers

GLUTARALINCI글루타랄Korean label name (MFDS standard)글루타랄(펜탄-1,5-디알)Korean label name (MFDS standard)PentanedialSynonym
CAS No.chemical registry number
111-30-8
EC No.EU chemical inventory number
203-856-5
DTXSIDUS EPA chemical ID
DTXSID6025355
DTXCIDUS EPA compound ID
DTXCID605355
IUPAC
Pentanedial
Molecular formula
C5H8O2
Molecular weight
100.117 g/mol

Measured properties

Appearance
Glutaraldehyde solution is a light yellow liquid. Mixes with water. (USCG, 1999) · Dry Powder, Liquid
Odour
Pungent odor · Sweetish
Boiling point
369 to 372 °F at 760 mmHg (decomposes) (NTP, 1992) · 187-189 °C (decomposes)
Melting point
less than 20 °F (USCG, 1999) · Freezing point: -14 °C
Solubility
greater than or equal to 100 mg/mL at 72 °F (NTP, 1992) · Miscible with water
Density
1.062 to 1.124 at 68 °F (USCG, 1999) · 0.72
Colour
colourless
Melting/freezing point
-33 ℃
Initial boiling point and range
102 ℃
Flash point
95 ℃
Vapour pressure
2.3 ㎪ (20℃)
Water solubility
100 ㎎/ℓ (72° F)
Vapour density
3.5
Relative density
1.13 (20℃)
n-Octanol/water partition coefficient (Kow)
-0.36 (at 23℃, pH7 EU Method A.8)
Auto-ignition temperature
395 ℃ (at 1013 hPa)
Viscosity
12.75 (25℃)
Molecular weight
100.12

Values measured on the substance itself. The KOSHA data are a reference for writing and reviewing safety data sheets, not a specification for a commercial raw material.

Source: PubChem · KOSHA safety data sheets (Korea)

What products actually use it for

What the 117 products reported to the US EPA with this ingredient use it for. Products outside cosmetics are included, so the top few rows are its main uses.

  • Preservative88
  • Biocide9
  • Processing aids not otherwise specified7
  • Pigment2
  • Fragrance2
  • Brightener2
  • Hardener1
  • Tanning agents not otherwise specified1
5 other uses
  • Anti-scaling agent1
  • Oxidizing agent1
  • Flavouring and nutrient1
  • Intermediate1
  • Embalming agent1

Source: US EPA CompTox dashboard

Irritation and sensitisation studies

21 skin studies and 11 eye studies are on record.

Classed as highly irritating2

The study conclusions largely agree (100%). These tests are on the raw material itself; irritation at the amount in a finished product is a different question.

See all 32 studies
  • Corrosive
    skin irritation: in vivo · Screening · OECD Guideline 404 (Acute Dermal Irritation / Corrosion) equivalent or similar to
  • Sah
    Skin Sensitization · Authoritative
  • Skin Corr. 1B
    Skin Irritation · Authoritative
  • Corrosive
    skin irritation: in vivo · Screening · other guideline: EPA 40 CFR 183 according to
  • Severe Irritation
    skin irritation: in vivo · Screening · OECD Guideline 404 (Acute Dermal Irritation / Corrosion) equivalent or similar to
  • Studies Indicate No Significant Irritation
    skin irritation: in vivo · Screening · other guideline: Draize Test according to
  • Skin Sens. 1A
    Skin Sensitization · Authoritative
  • Skin Sens. 1
    Skin Sensitization · Screening
  • Skin Corr. 1B
    Skin Irritation · Screening
  • Corrosive
    skin irritation: in vivo · Screening · OECD Guideline 404 (Acute Dermal Irritation / Corrosion) according to
  • Category 8.2B (Category 1B)
    Skin Irritation · Read Across
  • Skin corrosion/irritation - Category 1
    Skin Irritation · Screening
  • Skin sensitization - Category 1A
    Skin Sensitization · Screening
  • Category 6.5B (Category 1)
    Skin Sensitization · Read Across
  • Category 1
    Skin Irritation · Screening
  • Category 1
    Skin Sensitization · Screening
  • Category 6.3A (Category 2)
    Skin Irritation · Read Across
  • Ambiguous
    skin irritation: in vivo · Screening · other guideline: in vivo rabbit skin test method for corrosion, specified by the U.S. Dept. of Transportation (DOT). equivalent or similar to
  • Severe Irritation
    skin irritation: in vivo · Screening · OECD Guideline 404 (Acute Dermal Irritation / Corrosion) (adopted 1981) according to
  • Corrosive
    skin irritation: in vivo · Screening · other guideline: in vivo rabbit skin test method for corrosion, specified by the U.S. Dept. of Transportation (DOT). equivalent or similar to
  • Corrosive
    skin irritation: in vivo · Screening · OECD Guideline 404 (Acute Dermal Irritation / Corrosion) (as adopted 1981) equivalent or similar to
  • Eye Dam. 1
    Eye Irritation · Screening
  • Severe Irritation
    eye irritation: in vivo · Screening · other guideline: Draize Test according to
  • Corrosive or Irritation Persists for > 21 days
    eye irritation: in vivo · Screening · OECD Guideline 405 (Acute Eye Irritation / Corrosion) equivalent or similar to
  • Severe Irritation
    eye irritation: in vivo · Screening · EPA OPP 81-4 (Acute Eye Irritation) according to
  • Corrosive or Irritation Persists for > 21 days
    eye irritation: in vivo · Screening · other guideline: Fed. Reg. 38, No. 187, s 1500.42, p. 27019 of Sept. 27, 1973 according to
  • Studies Indicate No Significant Irritation
    eye irritation: in vivo · Screening · other guideline: Draize Test equivalent or similar to
  • Corrosive or Irritation Persists for > 21 days
    eye irritation: in vivo · Screening · other guideline: Draize Test according to
  • Severe Irritation
    eye irritation: in vivo · Screening · other guideline: Draize Test equivalent or similar to
  • Category 8.3A (Category 1)
    Eye Irritation · Read Across
  • Category 1
    Eye Irritation · Screening
  • Category 6.4A (Category 2A)
    Eye Irritation · Read Across

Source: US EPA CompTox dashboard

Related literature

Linked databases 28