Registration Dossier
Registration Dossier
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EC number: 226-552-4 | CAS number: 5423-23-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro gene mutation study in bacteria
Read across: OECD TG 471, S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A, 5000 µg/plate: not mutagenic with and without metabolic activation in all tester strains.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro gene mutation study in bacteria
The source substance guanidinium phosphate was tested in a study according to OECD 471 and GLP in S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvr A. The test item was applied in a concentration up to 5000 µg/plate. The results were negative in all strains with and without metabolic activation (Rat liver S9). Due to the same structures of the source and the target substance, there is no indication for a different genotoxic mode of action of the target substance. This is also confirmed by the profiling results of the OECD QSAR Toolbox v4.2. So, this result is also true for the target substance bisguanidinium phosphate. Therefore, bisguanidinium phosphate is also considered to be not mutagenic in bacterial strains.
Justification for classification or non-classification
The GLP in vitro gene mutation guideline study in bacteria with the source substance guanidinium phosphate was negative for all tester strains with and without metabloic activation. Due to the same structures of the source and the target substance, there is no indication for a different genotoxic mode of action of the target substance. Therefore, bisguanidinium phosphate is also considered to be not mutagenic in bacterial strains and does not require classification according to Regulation (EC) No 1272/2008 for mutagenicity.
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