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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
health surveillance data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented publication.

Data source

Reference
Reference Type:
publication
Title:
Bismuth salts and neurotoxicity. A randomised, single-blind and controlled study
Author:
Noach, L.A.
Year:
1995
Bibliographic source:
Hum. Exp. Toxicol. 14, 349-355

Materials and methods

Study type:
medical monitoring
Endpoint addressed:
acute toxicity: oral
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
medical monitoring, single blind case control
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Bismuth(3+) tripotassium bis[2-hydroxypropane-1,2,3-tricarboxylate]
EC Number:
260-872-5
EC Name:
Bismuth(3+) tripotassium bis[2-hydroxypropane-1,2,3-tricarboxylate]
Cas Number:
57644-54-9
IUPAC Name:
bismuth(3+) tripotassium bis[2-hydroxypropane-1,2,3-tricarboxylate]
Details on test material:
- Name of test material (as cited in study report): Colloidal bismuth subcitrate (CBS)
No further details are given.

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
A randomised, single-blind controlled study was carried out in 66 patients with H. pylori associated gastritis. Patients were randomised to receive either amoxicillin (control group) for 4 weeks or CBS for 8 weeks.
Clinical and neurophysiological tests including electroneurography (ENG) and spectral electroencephalography (EEG) were performed before and after therapy.

Results and discussion

Results:
No clinically relevant changes were observed with clinical tests as well as with ENG and spectral EEG recordings within each group and between the groups.

Applicant's summary and conclusion

Conclusions:
The normal use of colloidal bismuth subcitrate does not exhibit clinical neurotoxicity.