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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Guideline is not stated in the study report. However, the method used is described in sufficient detail and follows the standard acute method in principal.
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Chlorhexidine dihydrochloride
- EC Number:
- 223-026-6
- EC Name:
- Chlorhexidine dihydrochloride
- Cas Number:
- 3697-42-5
- Molecular formula:
- C22H30Cl2N10.2ClH
- IUPAC Name:
- chlorhexidine dihydrochloride
- Test material form:
- solid
- Details on test material:
- Chlorhexidindihydrochlorid
Chargen-Nr: 1/Dez. 83
CAS-Nr. 3967-42-5
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: male: 72 d, female 83- 84 d
- Weight at study initiation: male: 206-224 g, female: 153 - 179 g
- Fasting period before study: ca. 16 h prior to dosing
- Housing: Single in Macrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 d
- Number of animals per group: 5
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 50 - 60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: suspension tragant (0.5%)
- Details on oral exposure:
- Application of 21.5 mL/kg (equal to 5110 mg/kg bw)
- Doses:
- 5110 mg/kg bw
- No. of animals per sex per dose:
- m: 5
f: 5 - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not reported
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs - Statistics:
- LD50: Probit analysis
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 110 mg/kg bw
- Mortality:
- No deaths recorded
- Clinical signs:
- other: No signs of intoxication were observed
- Gross pathology:
- not tested
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this assay, chlorhexidine dihydrochloride was of very low oral toxicity to rats. The LD50 value for male and female animals was > 5000 mg/kg bw.
- Executive summary:
In this study performed according to OECD guideline 401, groups of 5 male and 5 female Wistar rats were dosed orally via gavage with chlorhexidine dihydrochloride. At the tested dose level (5110 mg/kg bw), no mortality or clinical signs was observed. Due to no mortality, the LD50 value for male and female animals was estimated to be > 5000 mg/kg bw. Under the conditions of the assay, chlorhexidine dihydrochloride was of very low oral toxicity to rats.
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.