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EC number: 215-235-6 | CAS number: 1314-41-6
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- effects on testes
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male rats were administered lead acetate in drinking water at concentrations of 0, 0.25, 0.5, and 1 g/L over 60 days and biochemical and histopathological analyses were performed on the testes.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Lead di(acetate)
- EC Number:
- 206-104-4
- EC Name:
- Lead di(acetate)
- Cas Number:
- 301-04-2
- IUPAC Name:
- lead (II) acetate trihydrate
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Initial weight at study initiation: 70-80 g.
- Water: Deionized water was available ad libitum.
ENVIRONMENTAL CONDITIONS
Not specified.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- Animals of the control group received deionized water ad libitum. Three other groups of animals received lead acetate in deionized drinking water ad libitum. Fresh solutions of lead acetate were prepared every day and a few drops of acetic acid were added to optimize solubility of the lead acetate.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Animals were dosed for 60 days.
- Frequency of treatment:
- Animals drank lead acetate-containing water ad libitum.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: g/L (nominal in water)
- Dose / conc.:
- 0.25 other: g/L (nominal in water)
- Dose / conc.:
- 0.5 other: g/L (nominal in water)
- Dose / conc.:
- 1 other: g/L (nominal in water)
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- One day prior to sacrifice, the animals were kept individually in metabolic cages and 24-hour urine samples were collected for ALA estimation.
- Positive control:
- None
Examinations
- Parental animals: Observations and examinations:
- Weight gain and fluid intake were recorded twice a week and the animals were observed for any overt signs of lead toxicity over a period of 60 days.
- Postmortem examinations (parental animals):
- All animals were lightly anesthetized with ether for collection of blood via heart puncture for blood lead estimation. Animals were then sacrificed by cervical dislocation, and testes were weighed and used for determining testicular concentrations of lead, ascorbic acid, and cholesterol. Testes were also fixed and sectioned for histopathological and histometric analyses.
- Statistics:
- All statistical analyses were performed by Student's t-test.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight was statistically significantly decreased at all tested doses.
- Water consumption and compound intake (if drinking water study):
- not specified
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Statistically significant increase in urinary δ-aminolevulinic acid (ALA).
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- There were statistically significant decreases in seminiferous tubule diameter and spermatid count at 0.5 g/L and above, and in spermatogenic count and Leydig cell number and nuclear diameter at 1 g/L. Spermatocytes and spermatids were in degenerative condition, and the lumen of the seminiferous tubules was filled with cellular debris at 0.5 g/L. At 1 g/L, the cellular pattern of the seminiferous tubules was disintegrated, spermatogenic inhibition was at the stage of spermatogonia, and Leydig cells were in atrophic condition.
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- BIOCHEMICAL: There were statistically significant increases in blood and testicular lead concentrations, urinary δ-aminolevulinic acid (ALA), and testicular cholesterol at all tested doses. There was a statistically significant decrease in testicular ascorbic acid at all tested doses.
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Details on results (P0)
BIOCHEMICAL: There were statistically significant increases in blood and testicular lead concentrations, urinary δ-aminolevulinic acid (ALA), and testicular cholesterol at all tested doses. There was a statistically significant decrease in testicular ascorbic acid at all tested doses.
HISTOPATHOLOGICAL: There were statistically significant decreases in seminiferous tubule diameter and spermatid count at 0.5 g/L and above, and in spermatogenic count and Leydig cell number and nuclear diameter at 1 g/L. Spermatocytes and spermatids were in degenerative condition, and the lumen of the seminiferous tubules was filled with cellular debris at 0.5 g/L. At 1 g/L, the cellular pattern of the seminiferous tubules was disintegrated, spermatogenic inhibition was at the stage of spermatogonia, and Leydig cells were in atrophic condition.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive
- Effect level:
- 250 mg/L drinking water
- Based on:
- not specified
- Sex:
- male
- Basis for effect level:
- other: Based on inhibition of spermatogensis (i.e., seminiferous tubular diameter, spermatid count, number of gametogenic cells in seminiferous tubules) at or above 0.5 g/L.
- Dose descriptor:
- LOAEL
- Effect level:
- 250 mg/L drinking water
- Based on:
- not specified
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
Results: P1 (second parental generation)
Effect levels (P1)
- Remarks on result:
- other: See 'Remarks':
- Remarks:
- Study investigated relative sensitivity of testicular physiology in rats exposed to lead via drinking water.
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- other: See 'Remarks'
- Remarks:
- Study investigated relative sensitivity of testicular physiology in rats exposed to lead via drinking water.
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- other: See 'Rmarks':
- Remarks:
- Study investigated relative sensitivity of testicular physiology in rats exposed to lead via drinking water.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The authors concluded that lead may inhibit spermatogenesis at the pre-meiotic stage via lack of testosterone production from Leydig cells.
- Executive summary:
Male rats were administered lead acetate in drinking water at concentrations of 0, 0.25, 0.5, and 1 g/L over 60 days and biochemical and histopathological analyses were performed on the testes. Body weight was statistically significantly decreased at all tested doses. Testicular weight was statistically significantly decreased at 1 g/L. There were statistically significant increases in blood and testicular lead concentrations, urinary δ-aminolevulinic acid (ALA), and testicular cholesterol at all tested doses. There was a statistically significant decrease in testicular ascorbic acid at all tested doses. There were statistically significant decreases in seminiferous tubule diameter and spermatid count at 0.5 g/L and above, and in spermatogenic count and Leydig cell number and nuclear diameter at 1 g/L. Spermatocytes and spermatids were in degenerative condition, and the lumen of the seminiferous tubules was filled with cellular debris at 0.5 g/L. At 1 g/L, the cellular pattern of the seminiferous tubules was disintegrated, spermatogenic inhibition was at the stage of spermatogonia, and Leydig cells were in atrophic condition. The reproductive NOAEL and systemic LOAEL from this study were both 0.25 g/L. The authors stated that high levels of cholesterol and decreased ascorbic acid along with atrophic Leydig cells in animals exposed to 1 g/L suggests non-utilization of cholesterol towards the synthesis of testosterone from Leydig cells. They concluded that lead may inhibit spermatogenesis at the pre-meiotic stage via lack of testosterone production from Leydig cells.
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