Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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.