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Diss Factsheets
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EC number: 910-427-2 | 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
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Used in EU risk assessment for zinc metal. Study well documented, meets generally accepted scientific principles, acceptable for assessment.
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:
- Changes in dietary zinc and copper affect zinc-status indicators of postmenopausal women, notably, extracellular superoxide dismutase and amyloid precursor proteins
- Author:
- Davis CD, Milne DB & Nielsen FH
- Year:
- 2 000
- Bibliographic source:
- Am. J. Clin. Nutr. 71: 781–8
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- repeated dose toxicity: oral
- Principles of method if other than guideline:
- Controlled metabolic ward study was performed to evaluate the effect of dietary zinc (and its relation to copper intake) on various indicators of zinc status in humans.
- GLP compliance:
- no
Test material
- Reference substance name:
- Zinc
- EC Number:
- 231-175-3
- EC Name:
- Zinc
- Cas Number:
- 7440-66-6
- Molecular formula:
- Zn
- IUPAC Name:
- zinc
- Reference substance name:
- Reference substance 001
- Details on test material:
- - Name of test material (as cited in study report): Zinc gluconate
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 25
- Sex: Female (postmenopausal)
- Age: 64.9 ± 6.7 yr
- Race: White
- Weight: 65.1 ± 9.5 kg
- Height: 159.6 ± 7.6 cm
- Known diseases: No underlying disease - Ethical approval:
- confirmed and informed consent free of coercion received
- Route of exposure:
- oral
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- After a 10 d equilibration period, volunteers divided randomly into two groups and consumed a diet with either a low (1 mg/d; n = 12) or a high (3 mg/d; n = 13) copper content based on a total energy content of 8.4 MJ. They received the same amount of copper throughout the study. Both groups were fed the basal diet (3 mg Zn/d) with no zinc supplement for one 90 d period, and after second 10 d equilibration period, the diet supplemented with 50 mg Zn/d for another 90 d period.
- Examinations:
- - Zinc concentrations of plasma and blood cellular components
- Plasma, erythrocyte and bone-specific alkaline phosphatase activity
- 5'-Nucleotidase activity in plasma, mononuclear cells, and erythrocytes
- Free and total triiodothyronine, free and total thyroxine, and thyroid-stimulating hormone (TSH) level as a measure of thyroid status
- Superoxide dismutase activity in erythrocytes and serum
- Amyloid precursor protein (APP) expression in platelets
- Ethanol tolerance test to determine effect of zinc intake on ethanol metabolism
All the analysis were performed during the last month of each dietary period. - Medical treatment:
- None
Results and discussion
- Clinical signs:
- No data
- Results of examinations:
- - Zinc concentrations: Plasma zinc concentrations were within the normal range for healthy adults (10.7–18.4 mmol/L) throughout the low-zinc
period. In contrast, levels were significantly elevated beginning 1 month after zinc supplementation and remained elevated throughout the zinc supplementation period. 8 of 23 volunteers had plasma zinc concentrations > 18.4 mmol/L at the end of the zinc-supplementation period. Neither erythrocyte nor erythrocyte membrane zinc concentrations responded significantly to changes in dietary zinc.
- Alkaline phosphatase activity: Zinc supplementation significantly increased bone-specific alkaline phosphatase activity (0.40 ± 0.02 compared with 0.32 ± 0.02 µkat/L) and seemed to increase plasma alkaline phosphatase activity (1.66 ± 0.02 compared with 1.57 ± 0.02 µkat/L); however, this difference was not significant. Erythrocyte membrane alkaline phosphatase activity did not change significantly with the different dietary treatments.
- 5'-Nucleotidase activity: Zinc supplementation significantly increased mononuclear white cell 5'-nucleotidase activity (17.90 ± 1.54 compared with 12.16 ± 1.54 U/L) (apparent only for high-copper diet group) and significantly decreased plasma 5'-nucleotidase activity (4.64 ± 0.19 compared with 6.36 ± 0.19 U/L). No change in red blood cell membrane activity.
- Thyroid status: Plasma free thyroxine concentrations were significantly higher and plasma free triiodothyronine concentrations tended to be higher, but not significantly so, during the high-zinc period than during the low-zinc period. However, dietary zinc did not significantly affect total thyroxine or triiodothyronine concentrations.
(See Table 2 in attached full study report for details of all the above mentioned parameters)
- Superoxide dismutase activity: Extracellular, but not erythrocyte, superoxide dismutase activity was significantly increased by zinc supplementation. This effect was more apparent when subjects were fed the low-copper diet. In contrast, zinc supplementation depressed erythrocyte superoxide dismutase activity (see Fig 1 in attached full study report).
- APP expression: Zinc supplementation significantly depressed platelet APP expression only when subjects were fed the low-copper diet (see Fig 2 in attached full study report).
- Ethanol tolerance test: Ethanol metabolism was not significantly affected by zinc intake. There were no significant differences in the rate of clearance of ethanol or in alcohol dehydrogenase activity among the different dietary treatments (see Fig 3 in attached full study report). - Effectivity of medical treatment:
- Not applicable
- Outcome of incidence:
- Not applicable
Any other information on results incl. tables
Remarks on thestudy, reported by Davis et al. (2000) and Milne et al. (2001):
From personal communication with the authors it appears that for ESOD activity the initial equilibration values varied markedly between individuals, and that for women who were assigned to the low copper group ESOD activity was substantially higher than for those assigned to the high copper group. This implicates that for this indicator, the assignment of the subjects to the two groups was suboptimal, which might also be the case for other indicators.
The frequent blood sampling (an average of no more than 235 ml per month was drawn) might have compromised the physiology of the subjects (as was suggested for haemoglobin).
The subjects served as their own controls: values upon both treatments (i.e. low and high zinc administration) were compared with values upon first equilibration. However, as the second treatment is not independent of the first treatment, the study design is not optimal.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, changes in dietary zinc and copper affect zinc-status indicators of postmenopausal women, notably, extracellular superoxide dismutase and amyloid precursor proteins.
- Executive summary:
- Controlled metabolic
ward study was performed to evaluate the effect of dietary zinc (and its
relation to copper intake) on various indicators of zinc status in humans.
Indicators of zinc status were measured in 25 healthy postmenopausal women aged 64.9 ± 6.7 y. After a 10 d equilibration period, volunteers consumed a diet with either a low (1 mg/d; n = 12) or a high (3 mg/d; n = 13) copper content based on a total energy content of 8.4 MJ. They received the same amount of copper throughout the study. Both groups were fed the basal diet (3 mg Zn/d) with no zinc supplement for one 90-d period, and the diet supplemented with 50 mg Zn/d for another 90 d period.
Zinc supplementation significantly increased extracellular but not erythrocyte superoxide dismutase activity. This increase was more apparent when subjects were fed the low copper diet. Zinc supplementation in combination with the low copper diet significantly decreased amyloid precursor protein expression in platelets. Other indicators of zinc status that were significantly elevated after zinc supplementation were as follows: plasma zinc, and free thyroxine concentrations and mononuclear 5'-nucleotidase (only apparent with high copper-diet), and bone-specific alkaline phosphatase activities.
In conclusion, changes in dietary zinc and copper affect zinc-status indicators of postmenopausal women, notably, extracellular superoxide dismutase and amyloid precursor proteins.
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