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EC number: 233-162-8 | CAS number: 10049-04-4
- 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

Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Alcide gel was used in this study (antimicrobial compound consisting of solutions of sodium chlorite and lactic acid that produce chlorine dioxide when mixed)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Pharmacodynamics of Alcide, a new antimicrobial compound, in rat and rabbit
- Author:
- Scatina JA, Abdel-Rahman MS, Gerges SE, Khan MY and Gona O
- Year:
- 1 984
- Bibliographic source:
- Fundamental and Applied Toxicology, 4: 479-484
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The dermal toxicity of Alcide gel was assessed following application of the gel to the backs of rabbits 5 days/week for 3 months.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Alcide Gel
- IUPAC Name:
- Alcide Gel
- Details on test material:
- Alcide Gel is a preparation composed of sodium chlorite and lactic acid, which when combined in equal volumes results in the formation of chlorine dioxide.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Forty rabbits (1.57 - 1.64 kg), twenty of each sex were used in the studies.
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- Duration of treatment: 3 months
- Frequency of treatment:
- Alcide gel was applied 5 day/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5, 1.0 and 2.0 g/kg
Basis:
other: Doses were administered on a gel weight basis containing 50 % Part A and 50 % Part B.
- No. of animals per sex per dose:
- 4 rabbits/sex/group
- Control animals:
- other: Eight animals received 2.0 g/kg of a placebo gel which contains the gelling material alone without the active ingredients. Another group served as the control and did not receive any treatment.
- Details on study design:
- Any test material remaining on the skin following the daily exposure was washed off prior to the new application.
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- After 3 months, blood was collected from all animals by cardiac puncture. White blood cell count, red blood cell count, haemoglobin concentration, packed cell volume, mean corpuscular volume, mean corpuscular haemoglobin and mean corpuscualr haemoglobin concentration were determined.
Clinical studies were conducted after 90 days. The remainder of the blood was used for the determination of glutathione (GSH), osmotic fragility and methemoglobin.
Organ/ body weight ratios were calculated .
The liver, kidney, lung, heart, ovary/testes, spleen, skin, stomach, duodenum and ileum from all rabbits were examined microscopically while microscopic examination of brain, pancreas, adrenals and thyroid was done only on animals from the high dose and control groups. - Other examinations:
- No data
- Statistics:
- Statistical analysis of food consumption, body weight, haematology, clinical chemistry, glutathione, osmotic fragility and organ/ body weight ratios were performed using an analysis of variance test and Duncan's multiple range test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS
All rabbits appeared healthy throughout the 90 day treatment period.
DERMAL IRRITATION
No changes were found at physical examination of the application sites during the experiment.
FEED CONSUMPTION AND BODY WEIGHT
These parameters were not significantly altered at any time point.
CLINICAL CHEMISTRY AND HAEMATOLOGY
In the 2.0 g/kg Alcide group as well as in the placebo group, creatinine values were elevated in serum, 1.60 ± 0.06 and 1.64 ± 0.07 vs 1.32 ± 0.08 for the control group, respectively. In addition the blood urea nitrogen/ creatinine ratio was reduced in the 2.0 g/kg group, 11.5 ± 0.8 compared to 14.6 ± 1.1 for the control group. In the 1.0 g/kg Alcide group, the carbon dioxide content was increased in serum while the serum inorganic phosphorous and calcium concentrations were decreased in serum.
No significant changes were noted in experimental aniamls compared to controls for any of the haematological parameters studied.
Glutathione content in blood was significantly decreased in the group receiving 2.0 g/kg Alcide gel as well as in the placebo gel group which also received 2.0 g/kg. Erythrocyte osmotic fragility was not altered and methemoglobin was not detected in blood.
ORGAN WEIGHT
In the group receiving 1.0 g/kg of Alcide gel, the liver/ body weight ration was significantly increased compared to the control group.
PATHOLOGY
All organs appeared normal.
HISTOPATHOLOGY
No histological changes were observed in the livers of either this group or in any other treatment group. Adrenal cortical hyperplasia was observed in all animals examined , including the control group and was the only significant histopathological alteration observed.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No data
Applicant's summary and conclusion
- Executive summary:
In a subchronic toxicity study, Chlorine Dioxide (ClO2) under Alcide gel form, was applicated on the backs of forty male and female New Zealand White rabbits at dose levels of 0.5, 1.0 and 2.0 g/kg bw for three months.
An animal group received 2.0 g/kg bw of a placebo gel which contains the gelling material alone without the active ingredients whereas another animal control group did not received any treatment.
After three months, blood was collected from all animals, clinical studies were conducted, organ/body weight ratios were calculated and several tissues were examined microscopically.
All rabbits appeared healthy at the end of the experiment and no changes were found at physical examination of the application sites during the experiment. Feed consumption and body weights remained stable during the treatment period.
Glutathione concentrations in blood were decreased in the group receiving 2.0 g/kg Alcide gel as well as in the placebo gel group which received the same concentration. The 1.0 and 0.5 g/kg Alcide groups did not have any alterations in glutathione content. This observation suggests that the gel itself was responsible for glutathione depletion.
No significant changes were noted in experimental animals compared to controls for any of the haematological parameters studied.
In the group receiving 1.0 g/kg of Alcide gel, the liver/ body weight ration was significantly increased compared to the control group.
No histological changes were observed in the livers of either this group or in any other treatment group.
In this dermal toxicity study using rabbits, no gross signs of toxicity were observed.
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