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EC number: 237-486-0 | CAS number: 13814-96-5
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1979-1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The rationale for the reliability scoring is based upon a Lead Study Quality Asessment tool for Pediatric Neurological Effects developed by the Scientific Advisory Panel assembled to provide independent academic review of the Voluntary Risk Assessment for Lead. The Pediatric Assessment assessed study quality on the basis of the following major aspects of study design, data collection, and analysis: Adequacy of Cohort Definition and Size Nature and Extent of Lead Exposure Indices Examiner Training and Procedures for Data Collection and Analysis Precision of Endpoint Definition Extent of Correction for Major Confounding Variables
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
- Study type:
- cohort study (prospective)
- Endpoint addressed:
- developmental toxicity / teratogenicity
- Principles of method if other than guideline:
- Epidemiological-Prospective Study
Test material
- Reference substance name:
- Lead
- EC Number:
- 231-100-4
- EC Name:
- Lead
- Cas Number:
- 7439-92-1
Constituent 1
Method
- Type of population:
- other: General Population: Pregnant mothers and their offspring
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- HYPOTHESIS TESTED (if cohort or case control study): A prospective method was used in this study to assess the effects of fetal lead exposure on neurodevelopmental status in 3- and 6-month old infants.
METHOD OF DATA COLLECTION
- Type: Interview / Questionnaire / Record review / Work history / Clinical tests / other:
- Details:
STUDY PERIOD: 1979-1987
SETTING: The final follow-up study sample consisted of 305 mothers, recruited between 1979 and 1984, residing in predesignated lead-hazardous areas of Cincinnati. This geographical area has a history of having a relatively large number of children with lead poisoning according to city health department data. Results of other studies on the Cincinnati cohort have shown that lead from paint, dust, and generally poor housing stock is the major contributor to body burden.
STUDY POPULATION
- Total population (Total no. of persons in cohort from which the subjects were drawn): 305 Mothers and Newborns
- Selection criteria:
- Total number of subjects participating in study:
- Sex/age/race:
- Smoker/nonsmoker:
- Total number of subjects at end of study:
- Matching criteria:
- Other:
COMPARISON POPULATION
- Type: State registry / Regional registry / National registry / Control or reference group / Other comparison group:
- Details:
HEALTH EFFECTS STUDIED
- Disease(s): Developmental Toxicity
- ICD No.:
- Year of ICD revision:
- Diagnostic procedure:
- Other health effects:
OTHER DESCRIPTIVE INFORMATION ABOUT STUDY: - Exposure assessment:
- measured
- Details on exposure:
- See Below (Any other info on mats and mets incl. tables)
- Statistical methods:
- The data analytic procedures used in this study were designed to achieve the best possible compromise between the conflicting goals of reducing the probability of type 1 error (ie, false-positive lead effect) and type II error (ie, false-negative (no) lead effect). The analytic strategy involves a priori specification of potential developmental confounders and covariates, pretesting covariables for confounding potential (P = .10), backward elimination of nonsignificant covariates and confounders through multiple regression analyses to a trimmed regression model, and, finally, the testing of potential dynamic interactions among lead exposures, biologic outcomes, and behavioral performance through structural equation analyses. Multiple regression analyses allow for the evaluation of the contribution of toxicant exposure to development, independent of covariables. Structural equation analyses go further to allow the testing of causal pathways wherein lead indirectly affects neurobehavioral status through its efect on covariables such as birthweight, gestation, or other perinatal factors.
Results and discussion
- Results:
- An inverse relationship between prenatal and neonatal blood lead levels and performance on the Bayley Mental Development Index (PDI) was found at 3 and 6 months of age. This effect was found to be mediated through lead's effect on birth weight, growth and maturation.
- Confounding factors:
- Undue lead exposure is known to covary with a number of social and biologic risks that may mimic, obscure, or otherwise interact with the effects of toxicant exposure on child development. Therefore, a substantial amount of medical and social background data were collected on all subjects. The candidate confounders and covariates that were selected a priori based upon their theoretical and/or known empirical association with the effects of toxicant exposure on child development are as follows:
Perinatal Variables: Birthweight; gestational age b y examination; obstetrical complications; postnatal complications scale; composite index of tobacco and alcohol consumption; no. of cigarettes smoked per day; maternal age at birth of child; gravidity; parity; maternal total iron-binding capacity; race of child; sex of child.
Sociohereditary Variables: Socioeconomic Status; Developmental Stimulation (Home Observation for Measurement of the Environment Scale); No. of children in the home
Any other information on results incl. tables
Covariate-Adjusted Parameter Estimates for Fetal lead Exposure Variables on 3 -Month Bayley Mental Developmental Index*
Prenatal (maternal) | Beta | SE | t value | P value | Range of Effect |
Umbilical cord | -.34 | 0.17 | -1.96 | .05 | 9.2 |
Newborn (10 days) | -.60 | 0.26 | -2.30 | .02 | 16.8 |
Newborn (3 months) | .06 | 0.22 | 0.26 | .79 | |
-.23 | 0.18 | -1.30 | .20 |
*Other variables remaining in final models as statistically significant (P < .05) covariates included birth weight, gestation, maternal age, child race, child sex, and socioeconomic status. Neither Composite Index of Tobacco and Alcohol Consumption nor quantity of cigarettes smoked per day remained in the models as statistically significant covariates. P value calculated by two-tailed test.
Covariate-Adjusted Parameter Estimates for Fetal Lead Exposure Variables on 6 -Month Bayley Mental Developmental Index*
Blood Source or Interaction | Beta | SE | t value | P value | Range of Effect |
Prenatal (maternal) | -0.76 | 0.34 | -2.16 | .02 | 22.7** |
Prenatal x child sex | 1.27 | 0.51 | 2.49 | .01 | |
Umbilical cord | -.066 | 0.37 | -1.76 | .08 | |
Newborn (10 d) | -3.49 | 1.29 | 2.69 | .007 | 16.1*** |
Newborn x socioeconomic status | 0.18 | 0.07 | 2.45 | .01 | |
Newborn (3 months) |
*Other variables remaining in the final models as statistically significant (P<<.05) covariates included birth weight, gestation, maternal age, child race, child sex, and socioeconomic status. Neither Composite index of Tobacco and Alcohol Consumption nor quantity of cigarettes smoked per dqay remained in the models as statistically significant covariates. P value calculated by two-tailed test.
** In male infants
*** In infants with scores less than the median socioeconomic status score for the sample.
Applicant's summary and conclusion
- Conclusions:
- An inverse relationship between prenatal and neonatal blood lead levels and performance on the Bayley Mental Development Index (PDI) was found at 3 and 6 months of age. This effect was found to be mediated through lead's effect on birth weight, growth and maturation.
- Executive summary:
A prospective method was used in this study to assess the effects of fetal lead exposure on neurodevelopmental status in 3- and 6- month old infants. At their first prenatal medical appointments, 305 lower socioeconomic status women residing in predesignated lead-hazardous areas of Cincinnati were recruited. lead was measured in whole blood in both the mother and fetal-placental unit (prenatal and cord) and the neonate (ten days and 3 months). All blood lead levels were less than 30 ug/dl. Infant development was assessed with the Bayley Scales at 3 and 6 months of age. Multiple regression analyses which treated perinatal health factors such as birth weight and gestation as confounders indicated an independent, inverse relationship between both prenatal and neonatal blood lead levels and performance on the Bayley Mental Development Index at both ages. The effect was found to be mediated through lead's effect on birth weight, growth and maturation. Male infants and infants from the poorest families appeared to be especially sensitive to these developmental influences.
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