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EC number: 218-058-2 | CAS number: 2044-56-6
- 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:
- toxicity to reproduction
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was well conducted and scientifically acceptable for assessment . However, available data are summarised and therefore not detailed.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- The effects of prolonged subtoxic lithium ingestion on pregnancy in rats
- Author:
- Trautner, E.M.
- Bibliographic source:
- Austral J Exp Biol. 1958;36:305-22
- Report date:
- 1958
Materials and methods
- Principles of method if other than guideline:
- No common testing procedure was followed. The publication comprised of a variety of tests. For details please refer to "Any other information on results"
- GLP compliance:
- no
- Remarks:
- study performed prior to GLP
- Limit test:
- no
Test material
- Reference substance name:
- Lithium chloride
- EC Number:
- 231-212-3
- EC Name:
- Lithium chloride
- Cas Number:
- 7447-41-8
- IUPAC Name:
- lithium chloride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
20 mmol/L
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
2 mmol/kg bw/d
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
13.9 mg Li /kg bw/d
Basis:
actual ingested
- Control animals:
- yes, concurrent vehicle
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Trautner (1958) reported a number of developmental/reproductive experiments in Wistar rats.
In the first experiment animals were treated with lithium in drinking water at 20 mmol/L for 3-7 weeks prior to mating and during gestation. No signs of toxicity or behavioral changes were observed. The mean time until pregnancy occurred, was 6 days for control and treated groups. 90 of 100 control females (90%) and 46 of 52 treated females (88%) gave birth to offspring. No damage to mothers or litters were noted.
In another experiment, 6 animals per sex and group received lithium in drinking water at 25 mmol/L beginning 17 days before mating. Treatment of females was continued during gestation. Under this experimental setting the rate of pregnant females was decreased when females were treated with lithium. In case only males were treated no effect on the pregnancy rate was observed. The authors stated that the females remained “healthy” through pregnancy. However, no data on maternal toxicity were reported. At 30 mmol/L already death occurred in the repeated dose study of Trautner (1958). No effects were observed when only the males were treated. Therefore, this effect might be due to maternal toxicity.
In the 3rd experiment, male and female rats were treated with lithium in drinking water at 20 mmol/L for presumably 17 days (not specified). No data on maternal or systemic toxicity were reported. 14/15 and 16/17 females gave birth when only males or females were treated with lithium, respectively. When both sexes received lithium 5/7 females delivered offspring. No effect on frequency of pregnancy was reported, although frequency in the latter group might be lower.
In experiment 4, rats received lithium chloride at 20 mmol/L in water for 3-7 weeks before mating and during gestation. Animals were allowed to give birth to offspring normally. No data on maternal or systemic toxicity were available.The experiment was performed in two series. In series 1, no differences in the mean litter size between control and treated females was observed (6.1 vs. 5.9). The mean litter size of treated females in series 2 was lower when compared to control (8.7 vs. 5.7). No malformations or difference in birth weight were found in any of the pups.The early postnatal growth of treated pups was transiently retarded. No differences were observed at later stages.
In another experiment (experiment 5), female rats received lithium chloride at 20 mmol/L in water for 3-7 weeks before mating and during gestation. Animals were laparotomized on gestation day 16-18. Numbers of corpora lutea, implants, and viable fetuses were assessed. Subsequently animals were allowed to give birth to offspring. No data on maternal toxicity were given. Statistically significant reduced corpora lutea (approximately 15%), implants, and viable fetuses were observed. No malformations were observed.
The last experiment, was performed as experiment 5. However, after weaning, born pups were treated with 20 mmol/L via drinking water for a period of 6-7 months. Thereafter, female offspring was mated with untreated males and laparotomized on gestation day 16-18. No controls were used within this experiment. However, data received were compared to the animals of experiment experiment 5.
No effects on the pubs were observed and it is stated that they were “in all aspects indistinguishable from normal rats”. However upon laparotomy significantly reduced numbers of corpora lutea and viable fetuses were observed. The lower number of implantations were not statistically significant when compared to controls of experiment 5.
Taken together, no effects on the pregnancy rates and litters were observed within the first three experiments at doses being not maternal toxic. However, within experiments 4 to 6 decreased numbers of corpora lutea and also decreased numbers of implantations and thus viable fetuses were observed. Upon birth a transient delay in development was reported occasionally but overall all pups developed normal. Based on these findings lithium showed no adverse effects on development of pups but may affect the early follicle development.
Applicant's summary and conclusion
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