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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 215-290-6 | CAS number: 1319-46-6
- 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
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Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- 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 acetate
- EC Number:
- 239-379-4
- EC Name:
- Lead acetate
- Cas Number:
- 15347-57-6
- IUPAC Name:
- lead(4+) tetraacetate
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.
- Details on mating procedure:
- Not applicable
- 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 / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.25, 0.5, 1.0 g/L
Basis:
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
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Other effects:
- effects observed, treatment-related
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
- 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
- Sex:
- male
- Basis for effect level:
- other: Based on decreased body weight at all doses tested.
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 tests. 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 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.
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.
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