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Diss Factsheets
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EC number: 223-026-6 | CAS number: 3697-42-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- This is a scientific study in accordance with generally accepted scientific principles. The study was specifically conducted to compare the sensitivity of the two standard skin sensitisation tests which are recommended by the OECD guideline 406. Only 5 animals/group were used, but 5 groups were used which received different concentrations of the test substance increasing the total number of animals and the sensitivity of the assay. There was no positive control in a strict way, but all other tested substances (including known skin sensitizers) in the study (chloraniline, eugenol, formaldehyde, mercaptobenzothiazole and neomycin sulphate) gave positive results demonstrating the validity of the assay. These alterations are not considered to be of any concern and the study is regarded relevant to assess the sensitisation potential of chlorhexidine digluconate.
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparison of the sensitivities of the Buehler test and the guinea pig maximization test for predictive testing of contact allergy
- Author:
- Frankild S, Volund V, Wahlberg JE & Andersen KE
- Year:
- 2 000
- Bibliographic source:
- Acta Derm Venereol 80, 256-262
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Pilot study: Yes
The procedure was performed according to Magnusson and Kligman. The GPMT procedure was modified with a multiple-dose design: 30 animals were assigned to one control group of 5 animals and 5 test groups containing 5 animals each, using different induction concentrations of the potential allergen for each group. Simultaneous increases in both intradermal and topical doses induction doses were used. In the multiple-dose GPMT procedure pretreatment with SDS was omitted. - GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- non-LLNA in-vivo methods were already available
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)
- Test material form:
- not specified
- Details on test material:
- chlorhexidine digluconate (Degussa AG)
analytical grade
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Source: Salblins, Malmö, Sweden
Weight at study initiation: 300-350 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.001-1 % in saline
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.01-10 % in saline (topical); tested up to highest concentration tolerated systemically and not producing skin necrosis
Concentration Freunds Complete Adjuvant (FCA): not reported
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 and 0.3 % in saline (up to maximum non-irritant concentration)
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 and 0.3 % in saline (up to maximum non-irritant concentration)
- No. of animals per dose:
- 5/group (5 treatment groups)
- Details on study design:
- Induction schedule: day 0 (intradermal + FCA) – day 7 (topical, occlusive)
Challenge schedule: day 21 (challenge) – day 35 (rechallenge)
Rechallenge: Yes
Scoring schedule: 48 h and 72 h after challenge - Challenge controls:
- 5
- Positive control substance(s):
- yes
- Remarks:
- chloraniline, eugenol, formaldehyde, mercaptobenzothiazole and neomycin sulphate
Results and discussion
- Positive control results:
- The other 5 tested substances gave a positive reaction
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: other: detailed scoring not reported.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: other: detailed scoring not reported.
- Key result
- Reading:
- rechallenge
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: other: detailed scoring not reported.
Any other information on results incl. tables
Results of pilot studies: Highest non-irritating topical concentration for challenge: 0.3 %.
Challenge: No animals in the test groups and no animals in the control showed a positive response to chlorhexidine digluconate in the challenge.
Re-challenge: Not explicitly stated, but chlorhexidine digluconate was reported to give negative result in the complete test.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the assay, chlorhexidine digluconate was not sensitising in a GPMT.
- Executive summary:
This is a scientific study in accordance with generally accepted scientific principles. The study was specifically conducted to compare the sensitivity of two standard skin sensitisation tests recommended by the OECD guideline 406.
Under the conditions of the assay, chlorhexidine digluconate was not sensitising in a GPMT.
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