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In vitro Bacterial mutagenicity (Ames Tests)

Rhodiasolv Polarclean has been evaluated in a bacterial mutagenicity assay in vitro (OECD 471/472) using four strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100) and one strain of Escherichia coli (WP2PuvrA) (Key study - Agh, 2009) .

In two separate experiments, the test substance did not induce any significant, reproducible increases in the observed numbers of revertant colonies in any strain with or without an auxiliary metabolising system (S9). Under the conditions of this assay, the test substance was considered non-mutagenic.

These results were confirmed in a second Ames test, assigned as supporting study and conducted for Japan registration purpose (Nakamura, 2014), where the test item did not induce gene mutations by base pair changes or frameshifts in the genome of any of the strains used.

In vitro mammalian cell mutagenicity

Rhodiasolv Polarcleanwas tested in the in vitro HPRT test in hamster V79 cellsin two independent experiments in the presence and absence of an auxiliary metabolising system (S9).No substantial and reproducible dose dependent increase of the mutation frequency was observed.

In vitro mammalian cell chromosome aberration

Rhodiasolv Polarclean was tested in the chromosome aberration assay using human lymphocytes in vitro, in two independent experiments in the presence and absence of an auxiliary metabolising system (S9). Neither a statistically significant nor a biologically relevant increase in the number of cells carrying structural chromosomal aberrations was observed after treatment with the test item. No evidence of an increase in polyploid metaphases was noted after treatment with the test item as compared to the control cultures.

In vivo mammalian erythrocyte micronucleus test

Rhodiasolv Polarclean was tested in the mouse micronucleus test to investigate potential to produce damage to chromosomes or aneuploidy. There were no statistically significant increases in the frequency of micronucleated PCE in any test item dose groups. Rhodiasolv Polarclean was considered to be non-genotoxic under the conditions of the test.


Rhodiasolv Polarclean was concluded not to have genotoxic potential.

Justification for selection of genetic toxicity endpoint
No specific study was selected since all available in vitro and in vivo studies were negative.

Short description of key information:
The name of the tested substance for the Ames test was DV-SOLV 1059, the previous name of Rhodiasolv Polarclean. The specifications of DV-SOLV 1059 are in line with the dossier and representative of the industrial product manufactured by Schirm.
Three in vitro genotoxicity studies are considered to be key studies covering the mutagenic and clastogenic endpoints of genotoxicity.
An Ames test (Agh, 2009; OECD 471/472, Rel. 1), The HPRT test in hamster V79 cells (Wollny, 2011; OECD 476 Rel. 1) and a Chromosome Aberration Assay (Bohnenberger, 2011; OECD 473, Rel. 1) all gave negative results. These studies confirm that Rhodiasolv Polarclean does not have genotoxic potential.
An in vivo mouse micronucleus study (Brown, 2012, OECD 474, Rel 1) was carried out to comply with the new substances regulations in China. This study also gave a negative result, confirming the lack of genotoxic potential of Rhodiasolv Polarclean.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on absence of mutagenicity and clastogenicity in four studies in vitro and one in vivo study, it is concluded that the Rhodiasolv Polarclean is not genotoxic. Therefore no classification is warranted according to the criteria of Annex VI Directive 67/548/EEC or EU Regulation 1272/2008 (CLP).