Registration Dossier
Registration Dossier
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EC number: 290-924-2 | CAS number: 90294-40-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
An Ames test is in progress and expected to be negative.
A GLP compliant study was performed according to OECD guideline 476 to investigate the potential of the analogue substance 1 to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster. The assay was performed in three independent experiments, using identical procedures, both with and without presence of an artificial metabolic activation system (rat liver S9 mix). Up to the highest investigated concentration no relevant increase in mutant colony numbers was obtained in two independent experiments. Appropriate reference mutagens were used as positive controls and showed a distinct increase in induced mutant colonies. In conclusion it can be stated that during the described mutagenicity test and under the experimental conditions reported the test article did not induce gene mutations at the HPRT locus in V79 cells. Therefore, the substance is considered to be non-mutagenic in HPRT assay.
Based on the read across considerations same resulta apply to Acid Orange 144
Justification for classification or non-classification
For analogue substance 1, results are a positive mutacenicity test in bacteria and a negative mutagenicity test in mammalian cells as well as a negative clastogenicity test in mammalian cells available.
From a
general toxicological point of view tests in mammalian cells superseed
results obtained in bacteria. In addition the molecular structure of
analogue substance 1 contains two nitro-groups in total. Nitro groups
represent an alert structure regarding genotoxicity testing in bacteria.
It is well-known for aromatic nitro compounds to be positive in the
Ames assay resulting from metabolism by the bacteria-specific enzyme
nitro-reductase [Tweats et al. 2012] while reactive oxygen species are
formed as a result of a futile redox cycle. However, it has been
demonstrated in various publications that this is a bacteria-specific
effect and that these Ames positive substances are not mutagenic in
mammalian assays.
It
is therefore considered that the result
of the Ames test as an artificial bacterial-specific effect with less
relevance for mammalian species and that the substance is not classified
for genotoxicity following Regulation 1272/2008.
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