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EC number: 242-354-0 | CAS number: 18472-51-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- other: clinical case reports
- Adequacy of study:
- other information
- Study period:
- 1987 - 2006
- Reliability:
- 2 (reliable with restrictions)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Hibiclens keratitis
- Author:
- Hamed S, Ellis FD, Boudreault G, Wilson FM & Helveston EM
- Year:
- 1 987
- Bibliographic source:
- Am J Ophthalmol 104, 50-56
- Reference Type:
- publication
- Title:
- Corneal edema related to accidental hibiclens exposure
- Author:
- Phinney RB, Mondino BJ, Hofbauer JD, Meisler DM, Langston RHS, Forstot SL & Benes SC
- Year:
- 1 988
- Bibliographic source:
- Am J Ophthalmol 106, 210-215
- Reference Type:
- publication
- Title:
- Corneal damage due to eye contact with chlorhexidine digluconate
- Author:
- Tabor E, Bostwick DC & Evans CC
- Year:
- 1 989
- Bibliographic source:
- J Am Med Assoc 261, 557-558
- Reference Type:
- publication
- Title:
- Hibiclens keratopathy
- Author:
- Varley GA, Meisler DM, Benes SC, McMahon JT, Zakov ZN & Fryczkowski A
- Year:
- 1 990
- Bibliographic source:
- Cornea 9, 341-346
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
- Study type:
- clinical case study
Test material
- Reference substance name:
- D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)
- EC Number:
- 242-354-0
- EC Name:
- D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)
- Cas Number:
- 18472-51-0
- Molecular formula:
- C22H30Cl2N10.2C6H12O7
- IUPAC Name:
- N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)] - D-gluconic acid (1:2)
Constituent 1
Results and discussion
- Clinical signs:
- A number of cases have been described in the medical literature of severe eye irritation and eye damage following the accidental contact of the eye with Hibiclens. According to the Material Safety Data Sheet and the Product sheet (Moelnlyke, 2006) for this compound (which is only marketed in the USA), hibiclens contains 4 % chlorhexidine digluconate, 4 % propan-2-ol and further, not-specified ingredients. According to Hamed et al. (1987), Hibiclens also contains detergents.
Hamed et al. (1987) described two cases of severe keratitis with permanent corneal opacification and blindness after accidental exposure of the eye to Hibiclens during ophthalmic surgery. In one case, a large central epithelial defect in the cornea remained 38 days after surgery. Though the epithelial effect gradually healed over a course of six weeks, the cornea became progressively opaque, ecstatic, and vascularised over the next 18 months. In the second case, Hibiclens was accidentally introduced into the eye during the scrub prior to eye surgery for cataract. Starting one day, an epithelial cornea defect developed and progressed, and the cornea became opaque. Four months after surgery, the a large epithelial defect persisted, a dense yellow-white sequestration was present, and the underlying cornea was thinned to one-fourth its normal thickness.
Further 5 cases were described by Phinney et al. (1988) where patients developed corneal lesions after accidental exposure to Hibiclens. All patients complained of postoperative ocular pain, had conjunctival inflammation, corneal epithelial defects, corneal edema 2 to 10 weeks later, and all developed corneal vascularization. Edema of 3 patients gradually cleared after months, but progressed to bullous keratopathy in 2 patients. Histopathological examination revealed lacking or degenerating keratocytes, loss of endothelial cells and an abnormal posterior collagenous layer. Permanent visual impairment was noticed in 2 patients.
Tabor et al. (1989) described two additional cases in which chlorhexidine digluconate solutions were used for preparing a patient's facial skin prior to surgery and accidentally got into the eyes. Exposure led to irreversible corneal damage with eye redness, pain and diminished vision.
A further case of keratopathy following accidental exposure of the eye to Hibiclens during preoperation preparation of the face was described by Varley et al. (1990). The patient developed epithelial and stromal oedema and later bullous keratopathy which led to penetrating keratoplasty 10 months later. The authors also mention further cases of similar eye damage described in the medical literature and discuss that the deep penetration of chlorhexidine into the cornea could be facilitated by detergent components present in the Hibiclens formulation.
Applicant's summary and conclusion
- Executive summary:
A number of case reports described in the medical literature show that a product (Hibiclens) containing a 4 % solution of chlorhexidine digluconate and other ingredients presents a severe hazard to the eye and may cause severe corneal damage. The presence of detergent may facilitate the penetration of chlorhexidine.
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