Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Daltolac R159 was evaluated in a bacterial reverse mutation assay (OECD 471 guideline study). The test material did not induce an increase in the frequency of revertant colonies in either the absence or presence of S9 -mix in either of two separate experiments (BioReliance, 2009).

Daltolac R159 was also evaluated in an in vivo mouse micronucleus assay (OECD 474). The test material did not induce a significant increase in the incidence of micronucleated polychromatic erythrocytes in the bone marrow of male ICR (CD-1) mice. Therefore, DADPM/DEG-PO was concluded to be negative in the mouse micronucleus assay (BioReliance 2013). The in vivo micronucleus test was requested by the National Institute of Environmental Research (NIER) of Korea for their registration of Daltolac R159.

To assess this endpoint further data from a read-across substance (based on grouping of substances (category approach)) ortho-Diaminotoluene, propoxylated were used. The results were negative in an in vitro chromosome aberration test and a HPRT assay. See section 13 for the read-across justification report.

The test material did not induce a statistically significant increase in the frequency of cells with chromosome aberrations in either the absence or presence of a liver enzyme metabolising system in either of two separate experiments (under GLP and according to OECD 473). The test material was therefore considered to be non-clastogenic to human lymphocytes in vitro (Safepharm, 2005).

The substance did not induce mutagenic effects in the in vitro gene mutation assay (HPRT test, according to OECD 476 and under GLP) with Chinese hamster V79 cells in the presence and absence of a metabolic activation system (Bayer Healthcare, 2008).

Short description of key information:
Daltolac R159 was tested in both in vitro bacterial reverse mutation assay and in vivo mouse micronucleus test. The both studies showed negative results. The results of chromosome aberration assay and HPRT test were further read-across from ortho-Diaminotoluene, propoxylated, a read-across substance based on grouping of substances (category approach) were negative; the chromosome aberration test (human lymphocytes) and an HPRT test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The findings from the in-vitro and in vivo genotoxicity testing do not warrant classification.