Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Mutaginicity data for C.I Pigment Orange 5 are characterized by a certain inconsistency. Most bacterial gene mutation (OECD 471) assays were positive and one test revealed an equivocal result. However there was neither consistency with regard to the requirement of metabolic activation nor with regard to the strains affected. As an overall conclusion, a gene mutation potential of C.I Pigment Orange 5 in bacteria can not be excluded.

Clear and negative studies for mutaginicity have been seen in vitro in OECD 473 and OECD 476. In vivo there were no marked increases in the incidence of unscheduled DNA synthesis in animals dosed with the test item (OECD 486) and PO5 is not mutagenic in the in vivo chromosome aberration test in bone marrow cells of the Chenese hamster (OECD 475).

Overall conclusion: the test item is not considered to be mutagenic.


Justification for selection of genetic toxicity endpoint
No adverse effects have been seen in vitro in OECD 473, OECD 476 while ambiguous or possitive test results have been seen in Ames tests with and without metabolic activation (OECD 471). In vivo there were no marked increases in the incidence of unscheduled DNA synthesis in animals dosed with the test item (OECD 486) and PO5 is not mutagenic in the in vivo chromosome aberration test in bone marrow cells of the Chenese hamster (OECD 475).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

C.I Pigment Orange 5 does not have to be classified for mutagenicity according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) because no adverse effects due to the test item have been seen in vitro in OECD 473 and OECD 476 studies while ambiguous, possitive and negative test results have been seen in Ames tests with and without metabolic activation (OECD 471). In vivo there were no marked increases in the incidence of unscheduled DNA synthesis in animals dosed with the test item (OECD 486).