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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
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study in French with English summary
Data source
Reference
- Reference Type:
- publication
- Title:
- Tolérance clinique des antiseptiques cutanés chez 3403 malades en pratique de ville
- Author:
- Caumes E, Le Maitre M, Garnier JM, Bricaire F & Crickx B
- Year:
- 2 006
- Bibliographic source:
- Ann Dermatol Veneorol 133, 755-760
Materials and methods
- Study type:
- other: Prevalence of adverse cutaneous reactions
- Endpoint addressed:
- other: Prevalence of adverse cutaneous reactions
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
Method
- Details on study design:
- The prevalence and the clinical forms of adverse cutaneous reactions were studied which are associated with the main antiseptics used in France. 3403 patients (mean age: 47 years; 61 % women; 39 % men) were included in the study. The patients for whom ambulatory treatment with a cutaneous antiseptic was performed were recruited from 773 French dermatologists during May and June 2003. Adverse reactions as reported by the patient in person or at telephone interview were validated by two independent experts.
Results and discussion
- Results:
- Among the 6 most widely used treatments (96 % of prescriptions), there were several containing chlorhexidine alone or in combination: chlorhexidine-benzalkonium (28 %), chlorhexidine-alcohol (16.5 %), aqueous chlorhexidine (7 %), and hexamidine-chlorhexidine (1.8 %). Of all patients treated, 4 to 7 % noticed a burning sensation, there was no significant difference between antiseptics. Detailed examination revealed 10 adverse events (9 with persistent burning sensation, one with contact dermatitis) (overall prevalence: 2.9/1000, ranging from 0-0.5 % for the various antiseptics). A history of contact dermatitis was associated with a risk of an adverse reaction (OR:7.2; 95 % C.I. 2-26.4).
There were no significant differences for the reactions between the different antiseptics.
Applicant's summary and conclusion
- Executive summary:
In this study, adverse skin reactions following the topical administration of antiseptics were studied in dermatological patients. A number of the antiseptics contained chlorhexidine, mostly in combination with other compounds.
No differences were noted between the different antiseptics. The results of the study indicate that adverse reactions of the skin following topical administration of antiseptics including chlorhexidine is a very rare event.
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