Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In all in-vitro genetic toxicity assays (Ames test, CA, V79/HGPRT test), Nickel, 5,5'-azobis-2,4,6(1H,3H,5H)-pyrimidinetrione complexes, Gelbpigment E4GN was negative.


Justification for selection of genetic toxicity endpoint
The results of the Ames tests, the chromosome aberration test and the HPRT test were considered

Short description of key information:
Nickel, 5,5'-azobis-2,4,6(1H,3H,5H)-pyrimidinetrione complexes, Gelbpigment E4GN, CAS 68511-62-6 was investigated in 2 Salmonella/microsome tests (Ames tests). In the study by Herbold, 1991 only 4 strains were used. Result: negative, no evidence of mutagenic activity was seen (with and without mutagenic activation). In a second ames test which was only available as secondary literature, 5 strains were tested (S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 andE. coli WP2 uvr A). The result was also negative with and without metabolic activation. Additional, Gelbpigment E4GN was evaluated as negative in an chromosome aberration test and also in a V79/HPRT test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Due to the negative results in all available in-vitro genetic toxicity tests a classification is not justified.