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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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No data are provided regarding the nature of the radiochemical impurities in the 14C-labelled chlorhexidine. Therefore, it must be considered that impurities such as breakdown products of lower molecular weight may have penetrated through the skin at a higher amount than chlorhexidine itself and contributed to the 14C-activity which was found in urine and faeces. This would have led to an overestimation of the percutaneous absorption of chlorhexidine. After the 24 h application of the test substance, excess material was wiped off but the animals were not washed. Since the animals were housed in the metabolism cages in pairs, it must also be considered that some remaining radioactivity at the site of application could have been licked up by the other animal leading to oral uptake and contributing to the excretion of radioactivity with the faeces. This would also contribute to an overestimation of the percutaneous absorption of chlorhexidine. Furthermore, the distribution of 14C-labelled chlorhexidine in blood and organs was not measured. However, the data on excretion and residual 14C-contents at the application site and in the skin patch clearly indicate that the overall amount of chlorhexidine in the body will be very small. Furthermore, in the same study, the structurally related OPB which was percutaneously absorbed similar to chlorhexidine could hardly be detected in most tissues including blood. The lack of distribution data for chlorhexidine is not considered a major drawback and the data of the study are considered relevant for the evaluation of the toxicokinetics of chlorhexidine digluconate.
Data source
Reference
- Reference Type:
- publication
- Title:
- Percutaneous absorption and tissue distribution of 1-(3,4-dichlorobenzyl)-5-octylbiguanide (OPB-2045) in rats
- Author:
- Kudo S, Furukawa M, Okumura H, Umehara K, Odomi M & Miyamoto G
- Year:
- 1 998
- Bibliographic source:
- Xenobiotic Metabolism and Disposition 13, 13-20
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 427 (13th April 2004)
- Deviations:
- not applicable
- GLP compliance:
- no
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
- Molecular formula:
- C22H30Cl2N10.2C6H12O7
- IUPAC Name:
- N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)] - D-gluconic acid (1:2)
- Details on test material:
- Test material: Chlorhexidine from Sigma Aldrich, Tokyo, Japan; 14C-(biguanide)-labelled chlorhexidine from Amersham, Tokyo, Japan; Gluconic acid from Wako Pure Chemical Industries, Osaka, Japan
Lot/Batch number: not given
Specification: Non-radioactive chlorhexidine was mixed with 14C-(biguanide)-labelled chlorhexidine base and with gluconic acid
Description: Non-radioactive chlorhexidine digluconate: 20 % aqueous solution
Purity: Non-radioactive chlorhexidine: no data; 14C-(biguanide)-labelled chlorhexidine base: radiochemical purity >= 97.2 %, specific activity 655 kBq/mg
Impurities: no data about the chemical nature
Stability: no data
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C-(biguanide)-labelled
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Charles River, Kanagawa, Japan
-Age at study initiation: 5-6 w
-Weight at study initiation: 188-245 g
-Individual metabolism cages: no (in pairs)
-Diet: ad libitum
-Water: ad libitum
-Acclimation period: ca. 1 w
ENVIRONMENTAL CONDITIONS
-Temperature (°C): 23 +/- 2
-Humidity (%): 60 +/- 10
-Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Duration of exposure:
- 24 h
- Doses:
- The test solution was prepared by mixing of gluconic acid with a 14C-labelled chlorhexidine solution at a 2:1 molar ratio and diluting to a final concentration of 0.04 (w/v) % a 14C-chlorhexidine (pH 4.74). 0.3 ml of the test solution was applied to a 2.5 cm2 patch, placed on the shaved back skin of the animals, covered with cloth tape, and held by elastic adhesive bandage.
- No. of animals per group:
- 3 m
- Control animals:
- no
- Details on study design:
- After an application time of 24 h the excess unabsorbed test material was removed by sanitary cotton.
Two groups of animals: group 1: shaved, intact skin; group 2: shaved, abraded skin (Stratum corneum removed by tape-stripping) with light erythema.
Animals were housed in pairs in metabolism cages. Urine and faeces were collected for 7 days. Cages were washed each day and washings were retained for analysis. Animals were sacrificed at the end of the study and carcasses were retained for analysis of radioactivity.
In the same study, the percutaneous absorption, distribution, and excretion of 14C-labelled 1-(3,4-dichlorobenzyl)-5-octylbiguanide (OPB), a related biguanide biocide, was also studied.
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- see below
- Total recovery:
- see below
Any other information on results incl. tables
No differences in percutaneous absorption were observed between animals with intact or damaged skin.
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Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the assay, the percutaneous absorption of chlorhexidine from topically applied liquid solutions of chlorhexidine digluconate is low.
- Executive summary:
In this study the percutaneous absorption of 14C-labelled chlorhexidine as chlorhexidine digluconate solution with an application to undamaged and damaged skin of rats under occlusive conditions for 24 h was studied. The recovery of chlorhexidine in skin patch, skin area, urine, and faeces was measured.
Under the conditions of the assay, the percutaneous absorption of chlorhexidine from topically applied liquid solutions of chlorhexidine digluconate is low. More than 97 % of the applied radioactivity was removed with the skin patch and only trace amounts (<= 0.3 %) could be detected in urine. No significant differences in toxicokinetics were observed between undamaged and damaged skin.
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