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INORGANIC GERMANIUM COMPOUNDS

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Because certain organic germanium containing agents such as carboxyethylgermanium sesquioxide and spirogermanium have shown promise as antineoplastic agents, some inorganic germanium compounds such as germanium dioxide and germanium lactate citrate have found their way into health foods, especially in Japan.

Specific Substances

    A) GERMANIUM DIOXIDE
    1) Molecular Formula: Ge-02
    2) Germanic acid
    3) CAS 1310-53-8
    GERMANIUM LACTATE-CITRATE
    1) Lactate-citrate germanate
    GENERAL TERMS
    1) Germanium Compounds, inorganic
    2) Germanium Compounds

Available Forms Sources

    A) SOURCES
    1) Consumer exposure has been due to ingestion in "health food supplements" taken to increase general energy levels. This practice has been particularly prevalent in Japan.
    2) Lactate-citrate germanate: This compound is a divalent lactate/citrate salt of germanium. Because it does not contain a carbon-germanium bond it is considered an inorganic salt.
    B) USES
    1) Germanium compounds are used as semiconductors in industry, especially in the manufacture of phosphors, transitors, diodes, and infrared-transmitting glass.

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) HUMAN - Acute overdose has not been reported, but chronic use of a germanium-lactate-citrate preparation has been associated with renal and other organ failure.
    B) ANIMALS - Mice and rats given fatal doses of germanium dioxide acutely developed sedation, excitation, seizures, impairment of locomotor activity, hypothermia, vasodilation, ptosis, cyanosis, tremor, and respiratory paralysis.
    C) Chronic ingestion of germanium salts used in health food products (dioxide, lactate citrate) has been associated with dyspnea, vomiting, tubulointerstitial nephropathy and renal failure, hepatic steatosis, weight loss, lactic acidosis, anemia, extremity numbness, muscle pains, weakness, and fatigue.
    0.2.6) RESPIRATORY
    A) Dyspnea has been reported following chronic ingestion.
    0.2.8) GASTROINTESTINAL
    A) Vomiting and weight loss have been reported following chronic ingestion.
    0.2.9) HEPATIC
    A) Hepatic steatosis has been reported following chronic ingestion.
    0.2.10) GENITOURINARY
    A) Chronic ingestion of germanium dioxide has caused myoglobinuria and renal failure.
    B) Chronic ingestion of germanium lactate citrate has caused persistent tubulointerstitial nephropathy.
    0.2.11) ACID-BASE
    A) Lactic acidosis has been reported with chronic ingestion of germanium lactate-citrate.
    0.2.13) HEMATOLOGIC
    A) Anemia has been commonly reported following chronic ingestion.
    0.2.15) MUSCULOSKELETAL
    A) Numbness in the extremities, muscle pains, weakness, and fatigue have all been reported in patients taking chronic germanium supplements.
    0.2.17) METABOLISM
    A) CPK, BUN, and serum creatinine were elevated in patients who ingested large amounts of germanium dioxide over several months. These patients had renal failure, but proteinuria and hematuria were not seen.

Laboratory Monitoring

    A) Elevated BUN, CPK, and serum creatinine may help diagnose the renal failure seen with germanium dioxide. Measurement of germanium in the hair and nails may also help confirm a diagnosis.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) Ingestions are primarily chronic in nature, so emesis or charcoal are not required.

Range Of Toxicity

    A) Ingestion of between 11 to 300 grams over 4 to 18 months has caused renal failure and anemia.

Clinical Effects

Summary Of Exposure

    A) HUMAN - Acute overdose has not been reported, but chronic use of a germanium-lactate-citrate preparation has been associated with renal and other organ failure.
    B) ANIMALS - Mice and rats given fatal doses of germanium dioxide acutely developed sedation, excitation, seizures, impairment of locomotor activity, hypothermia, vasodilation, ptosis, cyanosis, tremor, and respiratory paralysis.
    C) Chronic ingestion of germanium salts used in health food products (dioxide, lactate citrate) has been associated with dyspnea, vomiting, tubulointerstitial nephropathy and renal failure, hepatic steatosis, weight loss, lactic acidosis, anemia, extremity numbness, muscle pains, weakness, and fatigue.

Cardiovascular

    3.5.2) CLINICAL EFFECTS
    A) TACHYARRHYTHMIA
    1) Tachycardia (120 beats/minute) was reported in a 58-year-old male who developed renal failure following ingestion of germanium-lactate-citrate, total dose of 426 grams over a six month period (Luck et al, 1999). This patient also had a pericardial effusion.

Respiratory

    3.6.1) SUMMARY
    A) Dyspnea has been reported following chronic ingestion.
    3.6.2) CLINICAL EFFECTS
    A) DYSPNEA
    1) CASE REPORT - Dyspnea was reported in a 5-year-old taking germanium dioxide and other germanium compounds chronically (Higuchi et al, 1989).
    3.6.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) RESPIRATORY DISORDER
    a) RATS were given intratracheal germanium dioxide at doses of 30, 50, and 70 mg. Seven months later they had developed thickening of alveolar walls and hyperplasia of pulmonary lymphatic vessels (Mogilevskaja, 1973).

Neurologic

    3.7.2) CLINICAL EFFECTS
    A) NEUROPATHY
    1) Electromyography revealed spontaneous muscular activity and myotonic discharge without observation of clinical neurological signs in a 58-year-old male who had chronically ingested germanium-lactate-citrate over a 6-month period. The nerve conduction velocity was also delayed for the peroneal nerve, although it was normal for the median nerve. Six months after initial presentation, the patient's polyneuropathy persisted (Luck et al, 1999).
    3.7.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) CNS EFFECTS
    a) Mice and rats given fatal doses of germanium dioxide acutely, developed sedation, excitation, seizures, impairment of locomotor activity, hypothermia, vasodilation, ptosis, cyanosis, tremor, and respiratory paralysis (Vouk, 1986).

Gastrointestinal

    3.8.1) SUMMARY
    A) Vomiting and weight loss have been reported following chronic ingestion.
    3.8.2) CLINICAL EFFECTS
    A) VOMITING
    1) CASE REPORT - Vomiting was reported in a 5-year-old taking germanium dioxide and other germanium compounds chronically (Higuchi et al, 1989).
    2) Nausea and vomiting occurred in a 58-year-old male who developed renal failure after ingesting germanium-lactate-citrate for 6 months (Luck et al, 1999).
    B) WEIGHT LOSS FINDING
    1) Weight loss has been noted in patients who have been chronically ingesting germanium as a "health-food supplement" (Nagata et al, 1985; Okada et al, 1989; Luck et al, 1999).
    3.8.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) WEIGHT DECREASE
    a) Poisoned animals have also shown loss of fat (Rosenfeld & Wallace, 1953).

Hepatic

    3.9.1) SUMMARY
    A) Hepatic steatosis has been reported following chronic ingestion.
    3.9.2) CLINICAL EFFECTS
    A) STEATOSIS OF LIVER
    1) Hepatic steatosis was reported in two cases of chronic germanium ingestion (Nagata et al, 1985; Van Der Spoel et al, 1990).
    3.9.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) HEPATIC NECROSIS
    a) Acute and subacute studies in rodents found degenerative changes and necrosis of the liver and kidney (Vouk, 1986).

Genitourinary

    3.10.1) SUMMARY
    A) Chronic ingestion of germanium dioxide has caused myoglobinuria and renal failure.
    B) Chronic ingestion of germanium lactate citrate has caused persistent tubulointerstitial nephropathy.
    3.10.2) CLINICAL EFFECTS
    A) ABNORMAL RENAL FUNCTION
    1) CASE SERIES - Sanai et al (1990) reported 5 patients who, after taking germanium dioxide in health food products for periods of months (4 to 6), developed renal insufficiency. The total dose ranged from 27 to 250 grams.
    a) Serum creatinine gradually increased while on the germanium dioxide, and then, when the drug was discontinued, dropped to about 2.1 to 3.6 mg/dL where it stayed for 10 to 40 months. None of the patients had proteinuria or hematuria.
    2) CASE REPORT - Irreversible renal dysfunction was reported in a 57-year-old woman following ingestion of 12 mg of germanium daily for 2.5 years (total dose 10.8 g) (Van Der Spoel et al, 1990).
    3) CASE SERIES - Tubulointerstitial nephropathy, which persisted after germanium was discontinued, was reported in 2 patients infected with HIV taking germanium lactate citrate as an immunostimulant (Hess et al, 1993).
    4) CASE REPORT - A 25-year-old female took 2.5 g/d of germanium lactate citrate 18% over 9 months (total of 260 g; 47 g of germanium). At presentation the serum creatinine was 4.6 mg/dL, increasing to 9.9 mg/dL. Two years after germanium lactate citrate was discontinued the creatinine clearance was 14 mL/min/1.73 m(2) (Hess et al, 1993).
    5) CASE REPORT - A 26-year-old male reported taking germanium lactate citrate intermittently. The creatinine clearance was 43 mL/min/1.73 m(2) at presentation and unchanged after 9 months not taking germanium lactate citrate (Hess et al, 1993).
    B) RENAL FAILURE SYNDROME
    1) CASE SERIES - Okada et al (1989) reported renal failure and interstitial nephritis in three patients who ingested an unknown germanium salt at a dose of 90 mg per day for 6 to 20 months. The chronic renal failure occurred without abnormal urinary findings.
    2) CASE REPORT - Nagata et al (1985) reported a patient who died of acute renal failure after ingestion of 600 mg of germanium daily for 18 months.
    3) CASE REPORT - Renal failure was reported in a 58-year-old male who had ingested germanium-lactate-citrate for 6 months, a total dose of 426 grams. Urinalysis revealed erythrocytes and protein. Creatinine clearance was 11 mL/min and serum creatinine peaked at 424 mmol/L on day 8 of hospital admission. Electrophoresis of the urinary protein indicated tubular damage. Six months later renal dysfunction, with a creatinine clearance of 25 ml/min, persisted (Luck et al, 1999).
    3.10.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) RENAL NECROSIS
    a) Acute and subacute studies in rodents found degenerative changes and necrosis of the liver and kidney (Vouk, 1986).

Acid-Base

    3.11.1) SUMMARY
    A) Lactic acidosis has been reported with chronic ingestion of germanium lactate-citrate.
    3.11.2) CLINICAL EFFECTS
    A) LACTIC ACIDOSIS
    1) CASE REPORT - Ingestion of germanium lactate-citrate 2250 mg/day for 57 days was associated with lactic acidosis, renal failure, and hepatotoxicity in a 43-year-old female. During this time, the patient took other drugs, including selenium, alpha-tocopherol, tamoxifen and ferrous sulfate. The patient died 48 hours after germanium lactate-citrate was discontinued (Krapf et al, 1992).

Hematologic

    3.13.1) SUMMARY
    A) Anemia has been commonly reported following chronic ingestion.
    3.13.2) CLINICAL EFFECTS
    A) ANEMIA
    1) CASE SERIES - Anemia was reported in 5 patients who took small doses of germanium dioxide chronically over several months. The total dose ranged from 27 to 250 grams (Sanai et al, 1990). Okada et al (1989), Nagata et al (1985), and Matsusaka et al (1988) also described anemia in their patients.
    2) Normocytic, normochromic anemia was reported in a man who developed renal failure following long-term ingestion of germanium-lactate-citrate (Luck et al, 1999).

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) ERUPTION
    1) Skin irritation was reported with germanium TETRACHLORIDE (Vouk, 1986).
    3.14.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) LACK OF EFFECT
    a) RATS - When shaved rat skin was exposed to neutralized germanium dioxide topically, twice daily for two weeks, no irritation was seen (Rosenfeld, 1954).

Musculoskeletal

    3.15.1) SUMMARY
    A) Numbness in the extremities, muscle pains, weakness, and fatigue have all been reported in patients taking chronic germanium supplements.
    3.15.2) CLINICAL EFFECTS
    A) MUSCLE WEAKNESS
    1) Generalized muscular weakness and general malaise may occur after chronic germanium ingestion (Okada et al, 1989; Nagata et al, 1985).
    2) CASE REPORT - Weakness was reported in a 5-year-old taking germanium dioxide and other germanium compounds chronically (Higuchi et al, 1989).
    B) PARESTHESIA
    1) CASE REPORT - Numbness of the extremities and pain of the back muscles were reported in one patient (Matsusaka et al, 1988).
    3.15.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) MYOPATHY
    a) Animal studies and experimental data from rats suggest mitochondrial dysfunction causing myopathy (Higuchi et al, 1989).

Endocrine

    3.16.2) CLINICAL EFFECTS
    A) FINDING OF THYROID FUNCTION
    1) Elevated TSH (22.9 mU/L) was reported in a 58-year-old male following long-term ingestion of germanium-lactate-citrate. The TSH level gradually returned to normal following discontinuation of the germanium compound (Luck et al, 1999).
    B) DIABETES MELLITUS
    1) A 58-year-old male developed diabetes mellitus, requiring the twice-daily administration of insulin, following chronic ingestion of germanium-lactate- citrate. Laboratory analysis showed elevated levels of fasting glucose (10.7 mmol/L), glycosylated hemoglobin (11.1%), and C-peptide (8.06 ng/mL). Six months later, the patient's daily insulin requirement decreased to once-daily administration (Luck et al, 1999).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS7440-56-4 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Elevated BUN, CPK, and serum creatinine may help diagnose the renal failure seen with germanium dioxide. Measurement of germanium in the hair and nails may also help confirm a diagnosis.
    4.1.2) SERUM/BLOOD
    A) BLOOD/SERUM CHEMISTRY
    1) Measurement of serum creatinine, CPK, and BUN may be of aid in making the diagnosis of germanium induced nephrotoxicity. Serum creatinine, serum uric acid, and BUN may be elevated (Sanai et el, 1990).
    4.1.3) URINE
    A) URINALYSIS
    1) Chronic renal failure may occur without abnormal urinary findings such as proteinuria or hematuria (Okada et al, 1989). Proteinuria and hematuria are usually not present.
    4.1.4) OTHER
    A) OTHER
    1) HAIR
    a) In patients who ingest germanium in addition to that normally found in foods, hair and nails will show high germanium concentrations. In three patients who had been taking about 90 mg of germanium per day, the germanium concentrations (in micrograms per gram of dry weight) were (Okada et al, 1989):
     Patient 1Patient 2Patient 3
    Toenails14.615.8N/A
    Fingernails15.75.4N/A
    Hair56.4173.788

    b) In patients shown to have high germanium levels, these levels remained higher than controls even 5 to 24 months later (Sanai et al, 1990).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Monitoring

    A) Elevated BUN, CPK, and serum creatinine may help diagnose the renal failure seen with germanium dioxide. Measurement of germanium in the hair and nails may also help confirm a diagnosis.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) SUMMARY -
    1) Since ingestions are primarily chronic rather than acute, emesis or activated charcoal are not required.
    6.5.2) PREVENTION OF ABSORPTION
    A) SUMMARY
    1) Since ingestions are primarily chronic rather than acute, emesis, lavage, or activated charcoal are not required.
    6.5.3) TREATMENT
    A) SUPPORT
    1) Discontinuation of germanium therapy.
    2) Symptomatic treatment, if necessary for renal failure and anemia. Hemodialysis is occasionally required.
    3) Chelation has not been tried.

Enhanced Elimination

    A) SUMMARY
    1) Enhanced methods of elimination have not been tried.

Abstracts

Case Reports

    A) ADULT
    1) A 36-year-old who had ingested germanium containing products for about 6 months, was found to have increasing serum creatinine and BUN. He eventually required dialysis.
    2) On examination after his first dialysis, he had a normal physical examination and a urine that was normal except for being isotonic. His urine volume was 1200 to 1800 mL per day. Renal sonogram and renoscintigram showed no morphological abnormalities.
    3) A renogram found a fairly well-preserved renal blood flow and decreased renal function of the bilateral kidneys. A biopsy done one week after discontinuation of the germanium compounds showed degenerative changes with fine granular deposits in the distal tubular epithelium.
    4) Desquamated epithelial casts were noted in the dilated distal tubules. The glomeruli appeared normal. When a second biopsy was done two months later, the granular deposits had cleared, but the vacuolar degeneration of the distal tubluar epithelium was more prominent.
    5) He was discharged on the 88th day after admission after improvements had been seen in renal function.
    6) The urinary concentration of germanium was 7,080 nanograms/mL about 1 week after admission, and 14 ng/mL 7 months after discontinuation of the germanium dioxide (Sanai et al, 1990)

Range Of Toxicity

Summary

    A) Ingestion of between 11 to 300 grams over 4 to 18 months has caused renal failure and anemia.

Therapeutic Dose

    7.2.1) ADULT
    A) GENERAL
    1) The amount taken in health food supplements has ranged from 50 to 600 milligrams of germanium per day (Matsusaka et al, 1988).

Minimum Lethal Exposure

    A) CASE REPORTS
    1) A fatal case of acute renal failure was reported by Nagata et al (1985) in an adult who ingested germanium dioxide 600 milligrams per day for six months.

Maximum Tolerated Exposure

    A) CASE REPORTS
    1) NORMAL INTAKE - It is estimated that the ordinary amount of germanium ingested in foods is approximately 400 to 3,500 micrograms per day (Schroeder & Balassa, 1967).
    2) Renal failure was noted in patients taking the following doses.
    a) 5 patients who had ingested a total of 27 to 250 milligrams over several months (Sanai et al, 1990).
    b) 3 patients who ingested 90 milligrams per day for 6 to 20 months (Okada et al, 1989).
    c) A patient died with a dose of 600 milligrams per day for 6 months (Nagata et al, 1985).
    3) A 25-year-old who ingested a total of 30 grams of germanium dioxide over an eight month period (50 to 250 milligrams/day), developed renal failure and later died of cardiogenic shock (Matsusaka et al, 1988).
    4) A 36-year-old who ingested a total of 40 grams of germanium dioxide over 13 months (daily intake of about 70 to 140 mg) and developed anemia, renal failure, and muscular pain (Matsusaka et al, 1988).
    5) A 55-year-old ingested 47 grams of Ge element through various compounds. Renal failure developed (Takeuchi et al, 1992).
    6) A 58-year-old male ingested a total of 426 grams germanium-lactate-citrate (equivalent to 76 grams elemental Ge) over a 6-month period and developed renal failure, gastrointestinal distress, thyroid dysfunction, pericardial effusion, and diabetes mellitus (Luck et al, 1999). The renal dysfunction persisted six months after cessation of germanium intake.

Serum Plasma Blood Concentrations

    7.5.2) TOXIC CONCENTRATIONS
    A) TOXIC CONCENTRATION LEVELS
    1) ADULT
    a) The germanium concentrations in whole blood and serum were 4.3 milligrams/ liter and 3.7 milligrams/liter, respectively, in a 58-year-old male who had ingested a total dose of 426 grams germanium-lactate-citrate over a 6-month period (Luck et al, 1999).

Workplace Standards

    A) ACGIH TLV Values for CAS7440-56-4 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) NIOSH REL and IDLH Values for CAS7440-56-4 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS7440-56-4 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    D) OSHA PEL Values for CAS7440-56-4 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) References: Rosenfeld & Wallace, 1953
    1) LD50- (INTRAPERITONEAL)RAT:
    a) 750 mg/kg

Physicochemical

Physical Characteristics

    A) A white powder, hexagonal, amorphous, or tetragonal.

Molecular Weight

    A) 104.6

References

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