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Ingredient Dictionary

CHLORHEXIDINE

Chlorhexidine is a bisbiguanide compound with a structure consisting of two (p-chlorophenyl)guanide units linked by a hexamethylene bridge.

Molecular structure

Definition

US FDA substance register · UNII R4KO0DY52L · registered name CHLORHEXIDINE · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

Chlorhexidine is an organic compound that conforms to the formula:

Chlorhexidine is a bisbiguanide compound with a structure consisting of two (p-chlorophenyl)guanide units linked by a hexamethylene bridge. It has a role as an antibacterial agent and an antiinfective agent. It is a member of biguanides and a member of monochlorobenzenes. It is functionally related to a biguanide.

Source: PubChem

Cosmetic roles

Cares for the mouthORAL CAREInhibits microbial growthANTIMICROBIALStops microbes growing in the productPRESERVATIVE

Safety & regulatory references

Restricted
China · South Korea
Allowed preservative
United Kingdom

Source: Health Canada Cosmetic Ingredient Hotlist · MFDS (Korea) cosmetic regulatory information · EU Cosmetics Regulation · Japan Standards for Cosmetics · Taiwan FDA cosmetic ingredients · UK cosmetics regulations (OPSS)

Argentina · Brazil

  • Maximum concentration permitted at final product : 0.3% (expressed as chlorhexidine)

ASEAN

  • Maximum authorised concentration in the finished cosmetic product : 0.3% expressed as chlorhexidine

Canada

  • Maximum Concentration Permitted : a) 0.14% calculated as chlorhexidine free base b) 0.19% calculated as chlorhexidine diacetate c) 0.20% calculated as chlorhexidine digluconate d) 0.16% calculated as chlorhexidine dihydrochloride

Taiwan

  • 0.3%

Japan

  • Maximum amount per 100 g (Cosmetics not used for mucosa and to be washed away) : 0.10 g
  • Maximum amount per 100 g (Cosmetics not used for mucosa and not to be washed away) : 0.050 g
  • Maximum amount per 100 g (Cosmetics that may be used for mucosa) : 0.050 g

European Union

  • Maximum concentration in ready for use preparation : 0.3% (as chlorhexidine)

Source: MFDS (Korea) cosmetic regulatory information

Not classified under Korea’s toxic-substance GHS list

Source: Korea toxic substances GHS register (NIER)

Restriction V/42

Source: EU CosIng ingredient list

Reviewed by CIR: Annual Review of Cosmetic Ingredient Safety Assessments: 2007-2010

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: Final Report on the Safety Assessment of Chlorhexidine/Chlorhexidine Diacetate/Chlorhexidine Dihydrochloride/Chlorhexidine Digluconate

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: Note Regarding the Safety Assessment of Chlorhexidine, Chlorhexidine Diacetate, Chlorhexidine Digluconate, and Chlorhexidine Dihydrochloride

Source: US Cosmetic Ingredient Review (CIR)

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

Official labels & definitions

JCIA labelling name クロルヘキシジン: 本品は、次の化学式で表される芳香族化合物である。

Source: JCIA labelling names (Japan)

Names & identifiers

CHLORHEXIDINEINCI클로헥시딘Korean label name (MFDS standard)2,4,11,13-Tetraazatetradecanediimidamide, N1,N14-bis(4-chlorophenyl)-3,12-diimino-SynonymクロルヘキシジンJapanese labelling name
CAS No.chemical registry number
55-56-1
EC No.EU chemical inventory number
200-238-7
DTXSIDUS EPA chemical ID
DTXSID2033314
DTXCIDUS EPA compound ID
DTXCID0013314
IUPAC
N,N''''-Hexane-1,6-diylbis[N'-(4-chlorophenyl)triimidodicarbonic diamide]
Molecular formula
C22H30Cl2N10
Molecular weight
505.45 g/mol

Measured properties

Appearance
Dry Powder · Crystals from methanol, [HSDB]
Melting point
134 °C
Solubility
800 mg/L (at 20 °C) · MW: 578.38, crystals, decomposes 260-262 °C. Solubility in water at 20 °C: 0.06 g/100 mL /Chlorhexidine dihydrochloride/
Stability
Stable under ambient warehouse conditions to moisture and simulated sunlight. /Chlorhexidine diacetate/ · Stable under recommended storage conditions.
Dissociation constant
10.8 (at 25 °C)
Colour
white
Melting/freezing point
134 ℃
Initial boiling point and range
&amp, gt, 280 ℃
Flash point
32.9~311.6 ℃
Flammability (solid, gas)
flammable
Vapour pressure
0.000000000000000192 ㎜Hg (25 ℃, est.)
Water solubility
800 ㎎/ℓ (20 ℃)
Vapour density
17.45
Relative density
1.39 (20 ℃)
n-Octanol/water partition coefficient (Kow)
0.08
Auto-ignition temperature
(&amp, gt, 400℃)
Molecular weight
505.455

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 6 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.

  • Biocide4
  • Preservative2

Source: US EPA CompTox dashboard

Irritation and sensitisation studies

5 skin studies and 3 eye studies are on record.

Classed as low2

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 8 studies
  • Not classified
    Skin Irritation · Screening
  • SkinSens1
    Skin Sensitization · QSAR Predicted
  • Category 6.3A (Category 2)
    Skin Irritation · Read Across
  • Category 1
    Skin Sensitization · Screening
  • Studies Indicate No Significant Irritation
    skin irritation: in vivo · Screening · OECD Guideline 404 (Acute Dermal Irritation / Corrosion) according to
  • Corrosive or Irritation Persists for > 21 days
    eye irritation: in vivo · Screening · OECD Guideline 405 (Acute Eye Irritation / Corrosion) according to
  • Category 6.4A (Category 2A)
    Eye Irritation · Read Across
  • Category 1
    Eye Irritation · Screening

Source: US EPA CompTox dashboard

Related literature

Linked databases 26

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