Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro gene mutation:

Gene mutation study in bacteria (Ames test):

Read-across:

1. Based on the experimental results obtained with the analogue monosodium salt of cyanuric acid, monohydrate (S. typhimurium: TA100 Spot test: S. typhimurium: TA1535, TA1537, TA97, TA98 and TA100, with and without metabolic activation, genotoxicity negative, no citotoxicity) and the molecular weights, the read-across approach is applied and the same results can be extrapolated for substance trisodium cyanurate.

2. Based on the experimental results obtained with the analogue monosodium salt of cyanuric acid (Salmonella, with and without metabolic activation, genotoxicity negative) and the molecular weights, the read-across approach is applied and the same results can be extrapolated for substance trisodium cyanurate.

Cytogenicity study in mammalian cells (chromosome aberration test):

3 and 4. Based on the experimental results obtained in two studies with the analogue monosodium salt of cyanuric acid (CHO, with and without metabolic activation, genotoxicity negative) and the molecular weights, the read-across approach is applied and the same results for substance trisodium cyanurate can be considered.

Gene mutation study in mammalian cells (mouse lymphoma assay):

5 and 6. Based on the experimental results obtained in two studies with the analogue monosodium salt of cyanuric acid (mouse lymphoma L5178Y cells, with and without metabolic activation, genotoxicity negative) and the molecular weights, the read-across approach is applied and the same results can be extrapolated for substance trisodium cyanurate.

In vivo gene mutation:

1. Based on the experimental results obtained with the analogue monosodium salt of cyanuric acid (male, genotoxicity negative) and the molecular weights, the read-across approach is applied and the same results can be extrapolated to substance trisodium cyanurate.


Short description of key information:
Read-across from in vitro gene mutation studies in bacteria (Gridley and Ross, 1980),in vitro gene mutation studies in mammalian cells (Stewart, 1981) and In vitro cytogenicity studies (Kirby, 1981), which concluded that cyanuric acid and its analogues are not genotoxic under the conditions of the studies. In addition the results of an in vivo bone marrow cytogenetic assay (chromosome abberation assay, Sharma 1981) showed sodium cyanurate to be non genotoxic. Cyanuric acid is considered to be non-cytotoxic when tested up to its solubility limits.
The same results can be extrapolated to trisodium cyanurate.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

It is concluded that the available data indicate that cyanuric acid has no genotoxicity and therefore does not warrant classification for mutagenicity under DSD or CLP.

The same results can be extrapolated to trisodium cyanurate.