Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- other: Epidemiological - Mortality
- Adequacy of study:
- supporting study
- Study period:
- 1990-2003
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
- Study type:
- cohort study (prospective)
- Endpoint addressed:
- not applicable
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Prospective cohort study
Test material
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- HYPOTHESIS TESTED: Women with blood lead concentrations above a threshold will experience higher total and cause specific mortality.
METHOD OF DATA COLLECTION
- Type: Questionnaire; interview; clinical examination; blood sample; mortality
- Details: Each participant completed a baseline questionnaire that ascertained her education and health behaviors including smoking, alcohol use, and exercise. Participants were also asked about diagnosed diabetes and hypertension and the use of estrogen. At baseline, each participant had her blood pressure, height and weight measured and body mass index (BMI) calculated. Whole blood was drawn for blood lead measurements. Participants were contacted every four months after baseline visits (1991-1992) over 12 years of follow-up. Deaths were confirmed by death certificates.
STUDY PERIOD: 1990-2003
SETTING: University of Pittsburgh and University of Maryland clinics
STUDY POPULATION
- Total population (Total no. of persons in cohort from which the subjects were drawn): 9704
- Selection criteria: Participants were women aged 65 years and older and ambulatory, and were selected from the Study of Osteoporotic Fractures (SOF), a longitudinal cohort study that enrolled 9704 white women from 1986 to 1988 using population-based listings in Baltimore, MD; Minneapolis, MN; Portland, OR; and the Monongahela Valley near Pittsburgh, PA.
- Total number of subjects participating in study: 533
- Sex/age/race: White women aged 65-87 years
- Smoker/nonsmoker: 12% of participants were current smokers
- Total number of subjects at end of study: 533
COMPARISON POPULATION
- Type: Internal
- Details: Participants were categorized into two groups based on blood lead level
HEALTH EFFECTS STUDIED
- Disease(s): Mortality - Exposure assessment:
- measured
- Details on exposure:
- TYPE OF EXPOSURE: Environmental lead
TYPE OF EXPOSURE MEASUREMENT: Biomonitoring (blood)
EXPOSURE LEVELS: Mean blood lead concentration was 5.3 ± 2.3 μg/dL (range 1–21)
DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: Lead concentrations were dichotomized above and below 8 μg/dL, thus the two groups were: < 8 μg/dL (referent, n = 454), and ≥ 8 μg/dL (n = 79). - Statistical methods:
- The authors compared baseline characteristics by lead and mortality status, using chi-square tests for categorical variables and t-tests for continuous variables. Two-tailed p-values were used for all tests, at 5% statistical significance. Separate models were analyzed for all cause and cause specific mortality. Cardiovascular disease (CVD) mortality was categorized into two subgroups: deaths due to stroke, and coronary heart disease. Cox proportional hazards regression analysis were used to estimate the Hazard Ratio (HR) and 95% confidence intervals (CI) to determine association between blood lead concentration and mortality. The following variables were controlled for in all models: age increase per 5 years, clinic, BMI, education, smoking, alcohol intake, estrogen use, hypertension, total hip BMD, walking for exercise, and diabetes.
Results and discussion
- Results:
- A total of 123 (23%) women died over a mean follow-up of 12.0 (± 3) years. Women who died had 7% higher mean (± SD) blood lead [5.56 (± 3) μg/dL] than survivors: 5.17(± 2.0) μg/dL (p = 0.09). Women with baseline blood lead concentrations ≥ 8 μg/dL, had 59% increased risk of multivariate adjusted all-cause mortality (Hazard Ratio [HR] = 1.59; 95% confidence interval [CI], 1.02–2.49; p = 0.041), especially coronary heart disease (CHD) mortality (HR = 3.08; 95% CI, 1.23–7.70; p = 0.016), compared to women with blood lead concentrations < 8 μg/dL. There was no association of blood lead with stroke, cancer, or non-cardiovascular deaths.
- Confounding factors:
- Women with blood lead concentration ≥ 8 μg/dL had higher alcohol intake, were more likely to smoke, and had 8% lower total hip bone mineral density (BMD). As compared to survivors, women who died were older, more likely to smoke and to have hypertension. A lower proportion of women who died reported walking for exercise. Age, clinic, smoking, hypertension, and total hip BMD were significantly associated with mortality in women with blood lead concentration ≥ 8 μg/dL.
- Strengths and weaknesses:
- The authors noted that the strengths of their study include more than 95% complete follow-up for 12 years and controlling for a number of covariates and cardiovascular risk factors. The noted weaknesses include: participation limited to older Caucasian women, no determination of co-contaminants such as cadmium, no measures of factors that might influence the association between lead and mortality, and the possibility of some misclassification of the cause of death.
Applicant's summary and conclusion
- Conclusions:
- The authors concluded: "Women with blood lead concentrations of ≥ 8 μg/dL (0.384 μmol/L), experienced increased mortality, in particular from CHD as compared to those with lower blood lead concentrations."
- Executive summary:
This prospective cohort study of 533 women aged 65 -87 aimed to determine the association between blood lead and all-cause and cause-specific mortality in elderly women. After collection of baseline data from 1990-1991, a total of 123 (23%) women died over a mean follow-up period of 12.0 (± 3) years. Women who died had 7% higher mean blood lead [5.56 (± 3) μg/dL] than survivors: 5.17(± 2.0) μg/dL (p = 0.09). Women with baseline blood lead concentrations ≥ 8 μg/dL, had 59% increased risk of multivariate adjusted all-cause mortality (Hazard Ratio [HR] = 1.59; 95% confidence interval [CI], 1.02–2.49; p = 0.041) especially coronary heart disease (CHD) mortality (HR = 3.08; 95% CI, 1.23–7.70; p = 0.016), compared to women with blood lead concentrations <8 μg/dL. There was no association of blood lead with stroke, cancer, or non-cardiovascular deaths. The authors concluded: "Women with blood lead concentrations of ≥ 8 μg/dL (0.384 μmol/L), experienced increased mortality, in particular from CHD as compared to those with lower blood lead concentrations."
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
This website uses cookies to ensure you get the best experience on our websites.
Find out more on how we use cookies.