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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
Endpoint summary
Administrative data
Description of key information
Within a skin irritation study according to OECD Guideline 404, 3 Albino rabbits were treated with 0.5 g of the test substance moistened with 0.9 mL of Aqua demin to one intact and one scarified test site, which was occluded for 4 hrs after treatment. Scoring was done according to Draize 1, 24, 48 and 72 hrs after application. The treatment gave no indication for a dermal irritation potential and the PDII was calculated with 0.0. Edema and erythema scores were 0 in all animals at all time points.
In the eye irritation study according to OECD Guideline 405, 3 Albino rabbits were treated with 0.1 g of the test substance. Scoring was done according to Draize and effects were recorded for up to 21 days. The treatment caused corneal damage clouding; redding of conjunctiva, swelling of eye lids, hypersecretion. All effects are reversible within one week. No systemic toxicity was observed. In this test chlorhexidine dihydrochloride was judged as slightly irritating. Classification in GHS category 2 is warrented.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: ASTA-Werke AG, Bielefeld
-Age at study initiation: 5-6 months
-Weight at study initiation: 2 - 2.2 KG
-Housing: single in stainless steel cages
-Diet: Standard ssniff(R); no feed at treatment day
-Water: ad libitum
-Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
-Temperature (°C): 22 +/- 1
-Humidity (%): 50-60
-Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and scarified
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- Concentration: 0.5 g
- Duration of treatment / exposure:
- 4 hrs
- Observation period:
- up to 14 days after treatment
- Number of animals:
- 3
- Details on study design:
- TEST SITE
-Area of exposure: ca. 6.25 cm2
-% coverage: no data
-Type of wrap if used: occlusive
REMOVAL OF TEST SUBSTANCE
-Washing (if done): no data
SCORING SYSTEM: Draize - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1-72 hrs
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: no effects observed
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- No edema or erythema noted. Scoring was 0 for each animal and time point of 1, 24, 48 and 72 hours after treatment. Primary score 0.0.
- Other effects:
- No systemic effects noted.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The treatment gave no indication for a dermal irritation potential of chlorhexidine dihydrochloride.
- Executive summary:
In this study according to OECD Guideline 404, 3 Albino rabbits were treated with 0.5 g of the test substance moistened with 0.9 mL of Aqua demin to one intact and one scarified test site, which was occluded for 4 hrs after treatment. Scoring was done according to Draize 1, 24, 48 and 72 hrs after application.
The treatment gave no indication for a dermal irritation potential and the PDII was calculated with 0.0.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
-Source: ASTA-Werke AG, Bielefeld
-Age at study initiation: 5 months
-Weight at study initiation: 2.25 - 2.45 KG
-Housing: single in stainless steel cages
-Diet: ad libitum
-Water: ad libitum
-Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
-Temperature (°C): 22 +/- 2
-Humidity (%): 55 +/- 15
-Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye used as control
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- single application / not rinsed
- Observation period (in vivo):
- up to 21 days after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
-Washing: not rinsed
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4.6
- Max. score:
- 80
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 5.5
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 10.1
- Max. score:
- 110
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- corneal damage clouding (max. score 1 at day 1 and 2 in 1 animal); redding of conjunctiva (max. score 3 at 2 days in one animal), swelling of eye lids (max. score 2 at 1 day in one animal), hypersecretion (max. score 2 at 2 days in one animal), all effects reversible within one week, total score 10.1 (72 h).
- Other effects:
- No systemic-toxic effects were observed.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In this test chlorhexidine dihydrochloride was judged as slightly irritating. All effects were fully reversible within 7 days.
- Executive summary:
In this study according to OECD Guideline 405, 3 Albino rabbits were treated with 0.1 g of the test substance. Scoring was done according to Draize and effects were recorded for up to 21 days. The treatment caused corneal damage clouding; redding of conjunctiva, swelling of eye lids, hypersecretion. All effects are reversible within one week. No systemic toxicity was observed. In this test chlorhexidine dihydrochloride was judged as slightly irritating. Classification in GHS category 2 is warrented.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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.
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