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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 test for the strain TA 98 in the presence of metabolic activation S9 at 5000 µg/plate: positive.

- mammalian cell gene mutation test: negative.

- Ames test for the strain TA 98 in presence and absence of metabolic activation S9 at 5000 µg/plate: negative.

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

Genetic toxicity in vivo

Description of key information

Results of available in vitro study:

Single cell gel/Comet assay in rats: negative.

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

Additional information

Based on in vitro gene mutation study in bacteria, E131 Patent blue V sodium salt induces biologically significant increases in the number of revertants in the strain TA98 in the presence of metabolic activation at 5000 µg/plate. Anyway, EFSA noted that the positive outcome obtained in the presence of metabolic activation at higher dose levels, strongly indicates that mutagenicity may derive from the presence of impurities. In fact, this test was repeated on strain TA98 with and without metabolic activation at 5000 µg/plate and the result was negative. The test item does not show any potential for genetic toxicity.

The in vitro gene mutation study in mammalian cells showed no mutagenic potential at doses up to 2500 μg/ml. Therefore, EFSA considered the results of this assay inconclusive since the upper limit of concentration (5000 μg/ml) indicated by the relevant OECD guideline (OECD 476) was not tested.

The DNA damaging capabilities of the test item were assessed in the in vivo single cell gel/Comet assay in rats. In this study it concluded that E131 Patent Blue V induced no effect on DNA migration in rat liver, jejunum/ileum and peripheral blood after in vivo treatment.

Justification for classification or non-classification

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