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Toxicological information

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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Results of available in vitro studies:

- AMES tests: negative;

- Mouse lymphoma L5178Y gene mutation test: negative;

- Micronucleus and comet assay only without metabolic activation: positive (biological significance unclear);

- Micronucleous in Chinese hamster V79 with and without metabolic activation: negative.

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

Genetic toxicity in vivo

Description of key information

Results of available in vivo study:

- micronucleus test: negative.

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

Additional information

E104 Quinoline Yellow was negative in several studies conducted in bacterial cells, in a bacterial reverse mutation assay and in an in vitro micronucleus test in Chinese hamster V79 cells performed in compliance with the OECD guidelines. Negative results were also reported in an in vivo micronucleus assay conducted in accordance with OECD Test Guideline 474. As a consequence, EFSA ANS Panel (EFSA, 2009)and EFSA FEEDAP Panel (EFSA, 2013) considered E104 Quinoline Yellow of no concern for genotoxic potential.

Justification for classification or non-classification

Not classified for genetic toxicity according to the CLP Regulation (EC.1272/2008). For justification see additional information.