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EC number: 235-730-0 | CAS number: 12627-14-4
- 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
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- short-term repeated dose toxicity: other route
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- publication
- Title:
- Lithium chloride and dilithium carbamyl phosphate: lithium distribution and toxicity in mice
- Author:
- Jernigan, H.M., et al.
- Year:
- 1 977
- Bibliographic source:
- Toxicol Appl Pharmacol. 1978 May;44(2):413-21
Materials and methods
- Principles of method if other than guideline:
- Two groups of 15 mice each were given lithium chloride at 600 mg/kg bw/d twice-daily via ip-injections for 21, 23 or 30 days. Lithium concentrations were measured in blood and tissue samples.
- GLP compliance:
- no
- Limit test:
- yes
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
- Details on test material:
- - Supplier: Mallinckrodt Chemical Works, St. Louis, Missouri, USA
- Analytical purity: no data given
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- C57BL
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 168 - 180 days
- Diet: Purina Mouse Chow; ad libitum
- Water: water; ad libitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 21, 23, 30 days
- Frequency of treatment:
- twice daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
600 mg/kg bw/d
- No. of animals per sex per dose:
- 15 animals
- Control animals:
- other: Dilithium Carbamyl Phosphate, 1200 mg/kg bw/d
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 2 days prior to dosing, 4-6 h after first dose, on days 2, 7, 14, 21, 23, 30
- Animals fasted: No data
- How many animals: each animal
- Parameters were examined: leukocyte counts, packed cell volume. and random reticulocyte counts
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 2 days prior to dosing, 4-6 h after first dose, on days 2, 7, 14, 21, 23, 30
- Animals fasted: No data
- How many animals: each animal
- Parameters were examined: lithium content
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes: Spleen, brain, spinal cord, lumbar spinal nerve, lung, heart, skeletal muscle, parotoid salivary gland, thyroid, adrenal, kidney, urinary bladder, testes, epididymis, ovaries, oviduct, fetuses, lens, eye (lens removed), bone (cranium), skin and hair, liver, gall bladder, stomach, duodenum, ileum, cecum, colon - Other examinations:
- Tissue lithium was determined by the modified method of Schou (1958). Lithium analysis of tissue or of blood was done using a Perkin—Elmer Model 290E atomic absorption spectrophotometer.
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
3/7 males and 3/8 females of the lithium chloride group, and 7/10males and 1/5 females of the dilithium carbamide phosphate group died during the first 21 days. No spontanous deaths were noted thererafter. No mice died within 17 days after administration of sodium chloride.
BODY WEIGHT AND WEIGHT GAIN
The surviving mice in both groups had a small weight loss in the first week; thereafter they were gradually regaining the lost weight (no further data given).
HAEMATOLOGY
The mean leukocyte counts and the hematocrit of surviving mice in both groups decreased with time. At autopsy, the reticulocyte counts were elevated in both groups (greater than 4%) in all mice examined. Reticulocyte counts were highest (up to 11%) in those individual mice which had the lowest hematocrits.
CLINICAL CHEMISTRY
- The mean lithium concentrations in blood at different time points ranged from 1 to 2 mEq/liter with a mean for each group of 1.7 ± 0.7 mEq/liter averaging all values measured after lithium administration began. At the last routine bleeding before a nonsurvivor died, blood lithium ranged from 1.3 to 12 mEq/liter for lithium chloride and 1.4 to 11 mEq/liter for dilithium carbamide phosphate.
- After normalizing the dose of lithium, there were no significant differences (p > 0.05 using Student’s t-test) in survivors comparing the lithium concentration of each tissue in both groups (see table).
GROSS PATHOLOGY
At autopsy, no infection. inflammation, or hematomas were found at the site of the injections or in the peritoneal cavity.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- < 600 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: mortality and hematological effects
- Dose descriptor:
- NOAEL
- Effect level:
- < 1 400 mg/kg bw/day
- Based on:
- other: silicic acid, lithium salt
- Sex:
- male/female
- Basis for effect level:
- other: recalculated value based on the assumption that silicic acid, lithium salt contains 7% lithium (corresponding to MR: 2.8)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Tab. 1: Whole blood lithium concentration (mEy/L; mean ± SD) in mice survived until the end of study:
Days on study | |||||
0 | 2 | 7 | 14 | 21-30 | |
Lithium chloride (n = 6) | 0 | 1.9 ± 1.0 | 1.9 ± 0.5 | 1.6 ± 0.4 | 1.4 ± 0.5 |
Dilithium carbamide phopshate (n = 8) | 0 | 1.9 ± 1.1 | 2.0 ± 0.6 | 1.1 ± 0.3 | 1.9 ± 0.6 |
Tab. 2: Lithium distribution in tissues (mEq/kg wet weight):
Surviving 3 weeks | Died during 3 weeks | |||
Tissue | Lithium chloride | Dilithium carbamide phopshate | Lithium chloride | Dilithium carbamide phopshate |
Number of animals | 3 males, 3 females | 7 males, 1 female | 4 males, 5 females | 3 males, 4 females |
Blood (mEq/L) | 1.4 ± 0.5 | 1.9 ± 0.6 | - | - |
Spleen | 1.2 ± 0.3 | 18 ± 0.5 | 3-13 | 7-26 |
Brain | 1.2 ± 0.2 | 1.8 ± 0.5 | 8-12 | 6-18 |
Spinal Cord | 1.3 ± 0.4 | 1.7 ± 0.4 | 3-12 | 6-12 |
Lumbar spinal nerve | 2.4 ± 0.7 | 3.1 ± 1.0 (d) | - | - |
Lung | 1.9 ± 0.6 | 2.6 ± 0.8 | 11-18 | 5-13 |
Heart | 1.8 ± 0.5 | 2.4 ± 0.6 | 4-18 | 6-28 |
Skeletal muscle | 2.7 ± 0.9 | 3.4 ± 0.6 | 4-20 | 6-29 |
Parotoid salivary gland | 2.2 ± 0.4 | 2.9 ± 0.6 | 10-15 | 6-24 |
Thyroid | 1.9 ± 1.3 | 3.7 ± 2.2 | 13-31 | 9-50 |
Adrenal | 2.0 ± 1.6 | 1.8 ± 0.6 | 4-12 | 5-23 |
Kidney (whole) | 2.2 ± 0.5 | 2.7 ± 0.8 | 4-12 | 6-22 |
Kidney (cortex) | 2.3 ± 0.6 | 2.8 ± 0.8 | 4-14 | 6-23 |
Kidney (remainder) | 2.3 ± 0.5 | 3.0 ± 0.7 | 4-13 | 6-21 |
Urinary bladder | 2.1 ± 0.7 (d) | 4.0 ± 1.3 | 5-15 | 8-49 |
Urine (mEq/L) | 8.1 (e) | 19.46 (e) | - | - |
Testes | 1.4 ± 0.4 | 1.5 ± 0.5 | 4-10 | 5-21 |
Epididymis | 2.2 ± 1.1 | 4.0 ± 1.6 | 4-15 | 7-17 |
Ovaries | 1.5 ± 0.8 | 1.2 (e) | 8 (e) | 10 (e) |
Oviduct | 1.0 ± 0.3 | - | - | 4 (e) |
Fetuses | - | - | 4-6 | 10-15 |
Lens | 1.6 ± 0.4 | 2.3 ± 0.7 (d) | 3-16 | 9-25 |
Eyes (lens removed) | 2.5 ± 0.5 | 3.8 ± 1.2 | 16-21 | 11-38 |
Bone (Cranium) | 2.5 ± 0.3 | 3.0 ± 1.0 | 6-16 | 6-79 |
Skin and hair | 7.1 ± 2.8 | 4.5 ± 1.7 | 8-15 | 8-18 |
Liver | 0.8 ± 0.3 | 1.1 ± 0.5 | 4-12 | 6-14 |
Gall bladder | 1.9 ± 1.2 | 2.6 ± 0.7 | 6-13 | 2-17 |
Bile (gall bladder) | 10.7 (e) | 4.3, 9.5 (e) | - | - |
Stomach tissue | 1.2 ± 0.8 | 2.2 ± 2.1 (d) | 4-7 | 12 (e) |
Stomach contents | 1.2 ± 0.9 | 1.2 ± 0.4 (f) | 4-7 | 4-11 |
Duodenum tissue | 1.5 ± 0.4 | 1.6 ± 0.8 (d) | 4-16 | 9-27 |
Duodenum contents | 2.2 ± 1.2 | 2.6 ± 0.9 | 6-16 | 10-32 |
Ileum tissue | 1.8 ± 0.4 | 3.1 ± 1.4 (d) | 6-20 | 10-42 |
Ileum contents | 1.9 ± 0.7 | 5.3 ± 4.2 | 5-19 | 9-31 |
Cecum tissue | 3.8 ± 0.4 | 7.0 ± 2.5 (d) | 6-33 | 14-89 |
Cecum contents | 4.8 ± 1.6 | 10.1 ± 3.7 | 7-40 | 14-97 |
Colon tissue | 3.4 ± 0.8 | 5.5 ± 2.1 (d) | 6-21 | 10-27 |
Colon contents | 9.1 ± 4.3 | 15.2 ± 7.0 | 6-20 | 23-80 |
Feces | - | 25 ± 10 | - | - |
d: one mouse showing very high lithium content in this tissue was not included in the average
e: single sample
f: two mice showing very high lithium content in this tissue were not included in the average
Applicant's summary and conclusion
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