Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

ortho-Diaminotoluene, propoxylated was negative in a bacterial reverse mutation assay, an in vitro chromosome aberration test and a HPRT assay.

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 (under GLP and according to OECD 471).

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. 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.


Short description of key information:
Negative in an AMES test.
Negative in an in-vitro 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 genotoxicity testing do not warrant classification.