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EC number: 242-354-0 | CAS number: 18472-51-0
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Additional information
Short description of key information:
A two generation reproduction study according to OECD Guideline 416
is not available. However, there are data which indicate that there are
no effects on the reproductive organs, that there are no relevant
effects in the offspring and that offspring are not more sensitive than
dams:
The main observation in adult rats, i.e. the reactive histiocytosis of
mesenteric lymph nodes following oral administration of chlorhexidine
digluconate, has been investigated in a specially designed pre-,
postnatal and weaning study. In this study, oral treatment of dams from
day 15 of pregnancy until parturition or further through lactation to
day 21 postpartum had no effect on maternal weight gain, length of
gestation, litter size at birth, the number of dead pups per litter, or
on postnatal development.
In chronic toxicity studies with chlorhexidine digluconate in adult
rats, there were no treatment-related effects on the gonads of male and
female rats. Also, no histopathological effects on female or male
reproductive organs were observed in a carcinogenicity study with mice.
In a chronic toxicity study with dogs, adverse histological effects were
observed in the liver, but there were no effects in female or male
reproductive organs.
Toxicokinetic studies in humans indicate that there is only minimal if
any absorption of chlorhexidine after dermal single and repeated
exposure. Therefore, there is very little concern for systemic effects
on reproduction after dermal exposure.
From the overall evidence it is concluded that there is no concern for
effects of chlorhexidine digluconate on reproduction.
It is concluded that a two generation reproductive toxicity study for
chlorhexidine digluconate is not justified from a scientific viewpoint
and for animal welfare reasons.
Effects on developmental toxicity
Description of key information
A peri-, postnatal and weaning study in rats provides no evidence for a developmental toxic effect of chlorhexidine digluconate. Also a developmental and fertility toxicity study gave no concern for developmental or teratogenic effects.
As there is minimal if any dermal absorption of chlorhexidine after administration to the skin, it is considered that there is no concern for a specific developmental effect.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 0.18 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
The results of fertility and developmental toxicity studies with chlorhexidine digluconate are summarised in the following Table:
Route of exposure |
Test type |
Species |
Exposure Period |
Doses (mg/kg bw/d) |
Critical |
NO(A)EL (mg/kg bw/d) |
Oral, gavage |
Peri-, post-natal , weaning study |
Rat |
From day 15 of gestation up to |
0, 0.18, 0.89 or 8.9 (dams) 4.5 (pups in protocols C and D) |
Mild to moderate histiocytosis of mesenteric lymph nodes in dams and pups, same effect level, but effect more pronounced in dams than in pups |
0.18 |
Oral, gavage |
Teratology study |
Rat |
gestation day 6‑19 |
0, 10, 30 or 100 |
Dams: laboured breath at >= 30 mg/kg bw/d |
dams: 10 |
Justification for classification or non-classification
The available studies gave no concern for adverse effects.
Therefore, there is no need for classification.
Additional information
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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