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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Additional information

The following studies have been conducted with closely related read-across substances:

Bismuth subsalicylate was not mutagenic in the reverse mutation assay (Ames Test) with Salmonella typhimurium, tested at doses up to 666µg/plate.

Bismuth (III) trinitrate was not mutagenic in an in vitro mutation test in E. coli bacteria, tested up to 100 nmol/tube.

In a mammalian gene mutation test, bismuth subnitrate did not induce mutation at the hprt locus of L5178Y mouse lymphoma cells when tested under the conditions employed in this study. These conditions included treatments up to the maximum practicable concentration, 140 µg/mL (limited by solubility in the primary vehicle), in two independent experiments in the absence and presence of a rat liver metabolic activation system (S9).

Bismuth subnitrate was tested in a chromosome aberration assay using Chinese hamster V79 lung cells according to OECD Guideline 473. Bismuth subnitrate did not induce a significant level of chromosome aberrations in a repeatable, dose-dependent way in the performed experiments with or without metabolic activation. Therefore, bismuth subnitrate is considered not clastogenic in this test system.

Bismuth subsalicylate was tested in vitro in a chromosome aberration assay using Chinese hamster V79 lung cells according to OECD Guideline 473. Bismuth subsalicylate did not induce a significant level of chromosome aberrations in a repeatable, dose-dependent way in the performed experiments with or without metabolic activation. Therefore, bismuth subsalicylate is considered not clastogenic in this test system.


Justification for selection of genetic toxicity endpoint
No one study is selected as five studies are available with negative results.

Short description of key information:
By read-across to an Ames test (OECD Guideline 471) and a chromosome aberration test (OECD Guideline 473) with bismuth subsalicylate, a chromosome aberration test (OECD Guideline 473) and a mammalian gene mutation study with bismuth subnitrate and a bacterial gene mutation test with bismuth trinitrate, bismuth hydroxide is not classified for genetic toxicity. A read-across approach is considered acceptable due to the presence of the common bismuth component.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Bismuth hydroxide is not classified for genetic toxicity by read-across to the negative results of an Ames Test (OECD Guideline 471) and a chromosome aberration study (OECD Guideline 473) with bismuth subsalicylate, a bacterial gene mutation test with bismuth trinitrate, a chromosome aberration study (OECD Guideline 473) and a mammalian gene mutation study with bismuth subnitrate.