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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-238-7 | CAS number: 55-56-1
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study performed according to US EPA Proposed Guideline for Toxicology - Section 162.81-2, but only a summary of the full study is available. Due to the very high structural similarity between chlorhexidine base and chlorhexidine gluconate, the data generated for this endpoint using chlorhexidine gluconate are considered to be relevant for chlorhexidine base after dose level correction.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA - Proposed Guidelines for Toxicology - Section 162.81-2 and 5
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
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
- IUPAC Name:
- N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)] - D-gluconic acid (1:2)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no further data
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- application to abraded skin (no further data)
- Duration of exposure:
- no data
- Doses:
- 5 g/kg bw as chlorhexidine gluconate and 2.82 g/kg bw as chlorhexidine base
- No. of animals per sex per dose:
- 2 m / 2 f
- Control animals:
- no
- Details on study design:
- post-observation period: 14 d
- Statistics:
- no data
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 815 mg/kg bw
- Based on:
- other: chlorhexidine base
- Mortality:
- none
- Clinical signs:
- other: All rabbits were exceedingly hyperaemic at the end of 24 hrs. Moderate to severe (2 animals) or severe (2 animals) skin irritation into eschar formation. Skin thickening. Irritation subsided in 3 animals within one week, but in one animal, skin became ver
- Gross pathology:
- No significant findings on the interior side of the skin; all organs unremarkable
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the assay, chlorhexidine gluconate showed a very low acute dermal toxicity.
- Executive summary:
Acute dermal toxicity study in rabbits according to EPA guideline.
Under the conditions of the assay, 2815 mg/kg of chlorhexidiene base (5000 mg/kg of chlorhexidine gluconate) caused no death in rabbits. Moderate to severe skin irritation was observed that subsided in most animals within one week but led to epidermal scrubbing in one animal.
Overall, the test substance was irritating to the skin but the acute dermal toxicity of the test substance was low.
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.