Registration Dossier
Registration Dossier
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EC number: 943-995-5 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The analogue substance was tested for gene mutation following OECD 471 and EU Method B10(NONS dossier, 1997). For the Ames test, different strains at concentrations ranging from 10 to 5000 ug/plate were tested with and without S9 mix showing no potential for gene mutation.
For the in vitro mammalian gene mutation test, V79 cells were used with and without S) and did not show any mutagenic potential.
Based on the read across considerations same results apply to Reactive Orange 11.
Short description of key information:
Ames test, with and without S9 mix, 10 to 5000 ug/plate: negative
in vitro V79, with and withou S9 mix: negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Classification for mutagenicity under Regulation 1272/2008 is warranted for substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans. The classification in Category 2 is based on:
— positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:
— somatic cell mutagenicity tests in vivo, in mammals; or
— other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.
Based on the results from genetic toxicity tests the substance is not classified as mutagen.
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