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EC number: 946-329-1 | CAS number: -
- 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
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- November 1997 to February 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of Treatment with Zinc Gluconate or Zinc Acetate on Experimental and Natural Colds
- Author:
- Turner, R. B., Cetnarowski, W. E.
- Year:
- 2 000
- Bibliographic source:
- Clinical Infectious Diseases 2000; 31:1202-8
Materials and methods
- Study type:
- self-reporting of symptoms
- Endpoint addressed:
- acute toxicity: oral
- repeated dose toxicity: oral
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Two clinical trials were conducted, one involving 273 subjects with experimental rhinovirus colds and the other involving 281 subjects with natural colds. Symptomatic volunteers were randomized to receive oral lozenges containing zinc gluconate (13.3 mg), zinc acetate (5 or 11.5 mg), or placebo.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Bis(D-gluconato-O1,O2)zinc
- EC Number:
- 224-736-9
- EC Name:
- Bis(D-gluconato-O1,O2)zinc
- Cas Number:
- 4468-02-4
- Molecular formula:
- C12H22O14Zn
- IUPAC Name:
- zinc bis(2,3,4,5,6-pentahydroxyhexanoate) (non-preferred name)
- Details on test material:
- 13.3 mg
Constituent 1
- Specific details on test material used for the study:
- - Zinc Gluconate (lozenges, 13.3 mg)
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Details on study design:
- A total of 554 subjects were tested, of which 273 were challenged with rhinovirus type 39 and 281 presented a common-cold. The rhinovirus and the common-cold group were divided in four subgroups which received different treatments. Either the subject was treated with oral lozenges containing zinc gluconate (13.3 mg), zinc acetat (5 or 11.5 mg), or placebo.
Subjects were asked to judge the maximum severity of 7 symptoms—sneezing, rhinorrhea, nasal obstruction, sore throat, cough, headache, and hoarseness—occurring in the interval since the last symptom evaluation. Before each patient was randomized to treatment, the symptom scores were recorded in an interactive interview with the study staff once each day, and symptom scores for the 7 individual symptoms were summed to yield the total daily symptom score. After randomization to treatment, the symptom scores were recorded by the subject at »12-h intervals, just prior to the first and the last daily doses of study medication. The morning and evening symptom scores were averaged to provide a daily symptom score.
All subjects who met enrollment criteria for the study were challenged with rhinovirus type 39 and then isolated in hotel rooms for the next 5 days. Subjects were randomized to receive study medication 24 h after challenge if they had a total daily symptom score >3. Subjects who did not meet this symptom criterion were reassessed 48 h after challenge and randomized if they had a total daily symptom score >3. Subjects who did not have a symptom score >3 at one of these time points were not randomized to treatment. Treated volunteers continued receiving study medication >3 days and until cold symptoms resolved, as defined by 2 consecutive symptom scores <1, or until they had received treatment for 14 days. The duration of the cold was defined as the time from the start of study-medication administration to the first of the 2 consecutive symptom scores <1. In the subset of subjects studied at MUSC, nasal lavage was done each morning for the first 5 days after virus challenge, for detection of virus shedding and measurement of IL-8 concentration. The nasal lavage was done after the morning symptom assessment and before the first dose of study medication.
Subjects who presented to the study sites with a common-cold illness of <1 calendar day’s duration (effectively < 36 h), reported >2 different symptoms, and had a total symptom score of >2 were randomized to receive 1 of the treatments. As in the challenge study, all volunteers received medication >3 days and until cold symptoms resolved, as defined by 2 consecutive symptom scores <1, or until they had received treatment for 14 days. The duration of the cold was defined as the time from the start of study-medication administration to the first of the 2 consecutive symptom scores <1.
Results and discussion
- Results:
- Zinc gluconate treatment led to a significant reduction in the median duration of symptoms in volunteers with experimentally induced rhinovirus colds. This observation must be interpreted with caution, however, in light of the fact that zinc gluconate had no effect on the severity of symptoms during the first 3 days of treatment for induced colds and had no effect on either the duration or severity of natural colds. Zinc acetate lozenges had no effect on the duration or severity of symptoms in either the experimental or natural study model.
Applicant's summary and conclusion
- Conclusions:
- Zinc gluconate treatment led to a significant reduction in the median duration of symptoms in volunteers with experimentally induced rhinovirus colds. However, zinc gluconate had no effect on the severity of symptoms during the first 3 days of treatment for induced colds and had no effect on either the duration or severity of natural colds.
Zinc acetate lozenges had no effect on the duration or severity of symptoms in either the experimental or natural study model. - Executive summary:
Two clinical trials were conducted, one involving 273 subjects with experimental rhinovirus colds and the other involving 281 subjects with natural colds. Symptomatic volunteers were randomized to receive oral lozenges containing zinc gluconate (13.3 mg), zinc acetate (5 or 11.5 mg), or placebo. The median duration of illness in zinc gluconate recipients was 2.5 days, contrasted with 3.5 days in the placebo recipients, in the experimental colds study. Zinc gluconate had no effect on symptom severity and zinc acetate had no effect on either duration or severity. Neither formulation had an effect on the duration or severity of natural cold symptoms. Evaluation of blinding, taste, and adverse events revealed no significant differences among the 4 treatment arms.
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