Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 813-944-0 | CAS number: 1884575-91-0
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- This is a scientific study in accordance with generally accepted scientific principles. The salt chlorhexidine digluconate was used instead of chlorhexidine base. Due to the high level of structural similarity it is considered that the derived data also apply to the chlorhexidine base taking into account the differences in the stated concentrations. 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 and the fact that the digluconate salt was used are not considered to be of bigger concern and the study is regarded relevant to assess also the sensitisation potential of chlorhexidine base.
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)
- Version / remarks:
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 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.- Deviations:
- no
- Type of study:
- guinea pig maximisation test
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
Results and discussion
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Chlorhexidine tested using chlorhexidine digluconate was not sensitising in a GPMT using a multiple dose design. This test is considered the most relevant because it used several doses of the test substances, increasing the sensitivity of the assay, and was performed in accordance with current guideline. The weakly positive responses in a Buehler test in the same study and of a GMPT and a SIAT in another study may have been due to an irritant effect rather than a sensitisation and therefore do not provide reliable evidence for a sensitisation. The same holds true for the PLNA in mice. Regarding related substances, chlorhexidine diacetate was not sensitising in a modified Buehler test.
In humans, allergic reactions to chlorhexidine have been described. Allergic contact dermatitis to chlorhexidine is known but is rare (1 % or lower). In view of the widespread and worldwide use of chlorhexidine digluconate (and other chlorhexidine salts) over several decades, allergic reactions to chlorhexidine are considered an uncommon event.
In summary, it is concluded that chlorhexidine digluconate is not a skin sensitizer in standard animal tests. Allergic reactions in humans are rare.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.