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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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direct observations: clinical cases, poisoning incidents and other
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
not applicable
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented publication.

Data source

Reference Type:
Bismuth subcitrate nephrotoxicity
Sarikaya, M.; et al.
Bibliographic source:
Nephron 90, 501-502

Materials and methods

Study type:
poisoning incident
Endpoint addressed:
acute toxicity: oral
Test guideline
no guideline required
Principles of method if other than guideline:
case report, nephrotoxicity
GLP compliance:

Test material

Constituent 1
Reference substance name:
Bismuth(3+) tripotassium bis[2-hydroxypropane-1,2,3-tricarboxylate]
EC Number:
EC Name:
Bismuth(3+) tripotassium bis[2-hydroxypropane-1,2,3-tricarboxylate]
Cas Number:
bismuth(3+) tripotassium bis[2-hydroxypropane-1,2,3-tricarboxylate]
Details on test material:
- Name of test material (as cited in study report): Bismuth subcitrate
No further details are given.


Type of population:
- Number of subjects exposed: 1
- Sex: female
- Age: 17 years
- Race: Asian
No further details are given.
Ethical approval:
not applicable
Route of exposure:
Reason of exposure:
Exposure assessment:
Details on exposure:
The girl had taken 25 tablets containing 300 mg bismuth subcitrate (total 7.5 g).
- Urine analysis: yes
- Haematology: yes; laboratory examination of blood urea nitrogen (BUN), serum creatinine, uric acid , serum glutamic-oxaloacetic transaminase and lactic dehydrogenase.
- Other: physical examination, abdominal ultrasonography and colour doppler ultrasonography. Renal biopsy was performed.
Medical treatment:
The patient was managed with heamodialysis via subclavian vein catheter (6 times) and metoclopramide was added to treatment for nausea and vomiting.

Results and discussion

Clinical signs:
After ingestion of bismuth subcitrate, the girl noticed a progressive decrease in urine output. She was admitted to emergency room with complains of nausea, vomiting and anuria.
Results of examinations:
- Urine analysis: Urine examination showed ph 6.0, density 1020, protein 300 mg/dL, glucose 1000 mg/dL, 5-6 RBC and 3-4 WBC/hpf.
- Haematology: Laboratory examination revealed blood urea nitrogen (BUN) 71 mg/dL, serum creatinine 12.3 mg/dL, uric acid 8.5 mg/dL, serum glutamic-oxaloacetic transaminase 85 U/L and lactic dehydrogenase 2371 U/L.
- Other: Physical examination was unremarkable except pretibial and periorbital oedema and gastric pain. Abdominal ultrasonography revealed normal kidney size; however, renal parenchymal echo was increased. Colour doppler ultrasonography revealed no thrombus in renal vein and arteries. There was no glomerular pathology. Signs of acute tubular necrosis were encounted in the proximal tubule epithelium.
Effectivity of medical treatment:
On the 8th day of treatment, the patients urine volume was gradually increased. At that time, laboratory examination revealed BUN 91 mg/dL and creatinine 1.8 mg/dL. Urinary examination did not show any protein, erythrocyte or leukocytes.
On the 21st day she was discharged from the hospital with complete health and BUN and creatinine were within normal limits.
Outcome of incidence:
no data

Applicant's summary and conclusion

An overdose of bismuth subcitrate can cause renal necrosis.