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EC number: 931-722-2 | 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
Data source
Materials and methods
- Type of study / information:
- Bioavailability of ingested lead in humans.
- Endpoint addressed:
- basic toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- This study examined the bioavailability of lead in wine using a human in vivo model. The study was a single-dose, nonrandomized cross-over study. Blood was obtained for screening of lead isotope ratios from 61 adult subjects in New York, United States; 10 adult subjects in Glasgow, Scotland; and 12 adult subjects in Brisbane, Australia. In New York, six subjects were chosen (ages 21-40 years), with blood lead concentrations <0.24 µmol/L, and 206Pb/207Pb ratios ≥1.195. Participants were admitted to the Clinical Research Center twice, one week apart. During the first admission, subjects ingested sherry obtained from the original bottle. During the second admission, they ingested sherry that had been stored for three years in a lead-crystal decanter and had a lead concentration of 14.2 µmol/l. The ratio of 206Pb/207Pb and total lead content were simultaneously measured in the blood and the urine.
- GLP compliance:
- no
Method
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- SETTING: Clinical Research Center
HEALTH EFFECTS STUDIED: In vivo bioavailability of lead.
Results and discussion
- Results:
- Most New York subjects had blood 206Pb/207Pb ratios of 1.195 or higher. Australian subjects had the lowest 206Pb/207Pb ratios, ranging from 1.095 to 1.145. Scottish subjects had only slightly higher values, ranging from 1.105 to 1.155. Table 1 presents the results of this study. Prior to the ingestion of sherry that had been in a lead-crystal decanter (206Pb/207Pb = 1.078), the mean blood lead level was 0.10 µmol/L and the mean 206Pb/207Pb ratio was 1.202. After consumption of the sherry, the blood lead levels rose and the 206Pb/207Pb ratio fell to attain values in the range 1.118-1.150 at 48 hours. These changes were essentially complete by 24 hours, at which time the mean blood lead level had risen to 0.18 µmol/L (p = 0.0003) and the mean blood 206Pb/207Pb ratio had fallen to 1.137 (p = 0.0001). In contrast, neither blood lead level (Table 1), blood 206Pb/207Pb ratio, nor ALAD changed significantly after the consumption of sherry obtained from the original bottle. On average, by 24 hours, 38.4% of the administered lead dose was in the blood compartment. Bioavailability was estimated by comparing the kinetics of an oral dose to those of an intravenous dose. Previous studies of intravenous 203Pb indicate that at 24 hourw, 55% of an administered dose is still in the blood compartment. The authors estimated the mean fraction of lead absorbed from the sherry to be 70%. Individual values for bioavailability were 96, 83, 77, 71, 47, and 46%.
Any other information on results incl. tables
Table 1: Demographics and findings of the study.
Control Hospitalization |
Lead Crystal Hospitalization | |||||||||||
BPb (µmol/L) | BPb (µmol/L) | 206Pb/207Pb | ||||||||||
Subject | Age (years) | Weight (kg) | Race | Gender | Start | 24 hr | Dose Pb (µmol) | Start | 24 hr | Start | 24 hr | % Absorbed |
1 | 24 | 60.6 | White | F | 0.16 | 0.16 | 1.04 | 0.17 | 0.29 | 1.206 | 1.148 | 96 |
2 | 23 | 58.2 | Black | F | 0.09 | 0.07 | 1 | 0.06 | 0.16 | 1.202 | 1.12 | 83 |
3 | 28 | 48 | Asian | F | 0.06 | 0.07 | 0.83 | 0.07 | 0.14 | 1.204 | 1.144 | 46 |
4 | 26 | 73.5 | White | M | 0.1 | 0.1 | 1.26 | 0.1 | 0.19 | 1.199 | 1.135 | 77 |
5 | 24 | 80 | Black | M | 0.11 | 0.11 | 1.38 | 0.08 | 0.14 | 1.196 | 1.142 | 47 |
6 | 24 | 60 | Black | F | 0.09 | 0.11 | 1.03 | 0.09 | 0.17 | 1.202 | 1.135 | 71 |
Mean | 25 | 63.4 | 0.1 | 0.1 | 1.09 | 0.1 | 0.18* | 1.202 | 1.137** | 70 | ||
*p= 0.0003, compared to starting BPb. | ||||||||||||
**p= 0.0001, compared to starting 206Pb/203Pb ratio. | ||||||||||||
BPb = Blood lead concentration |
Applicant's summary and conclusion
- Conclusions:
- The authors concluded that lead leached from lead-crystal glass is highly bioavailable as, on average, 70% of the ingested dose of lead was absorbed. Repeated ingestions may cause elevated blood lead concentration. The authors concluded that for a 70-kg subject, a single dose of 0.48 µmol of lead in sherry will induce a rise in blood lead concentration of approximately 0.05 µmol/L. The technique of stable isotope dilution is useful for the study of the bioavailability of lead in other matrices, including soil.
- Executive summary:
The authors sought to determine the bioavailability of lead leached from a lead-crystal decanter, using the technique of stable isotope dilution in blood. The bioavailability of lead in any matrix can be determined by isotope dilution provided the isotopic ratio of the ingested samples is sufficiently different from that in the blood of the subjects who ingest it. The lead-crystal decanter was manufactured with lead from Australia, where the ratio of 206Pb/207Pb is distinctly different from that in the United States. The authors conducted a single-dose, nonrandomized cross-over study in which participants were admitted to the Clinical Research Center twice, one week apart. During the first admission, subjects ingested sherry obtained from the original bottle. During the second admission, they ingested sherry that had been stored in the lead-crystal decanter and that had achieved a lead concentration of 14.2 µmol/L. After ingesting decanter-stored sherry, mean blood lead increased (p = 0.0003) from 0.10 to 0.18 µmol/L, while mean 206Pb/207Pb fell from 1.202 to 1.137 (p = 0.0001). On average, 70% of the ingested dose of lead was absorbed. The authors concluded that lead derived from crystal glass is highly bioavailable; repeated ingestions could cause elevated blood lead concentrations. The advantage of the technique of stable isotope dilution is its sensitivity and precision, which allows one to estimate bioavailability even when the fraction of lead absorbed is as low as 5%.
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