Registration Dossier
Registration Dossier
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Reaction mass of tetrasodium [mono(4,4'-(1Z,1'Z)-(4,4'-dioxidobiphenyl-3,3'-diyl)bis(diazene-2,1-diyl)bis(5-amino-3-oxidonaphthalene-2,7-disulfonate(3-)) cuprate (4-)] and tetraammonium [mono(4,4'-(1Z,1'Z)-(4,4'-dioxidobiphenyl-3,3'-diyl)bis(diazene-2,1-diyl)bis(5-amino-3-oxidonaphthalene-2,7-disulfonate(3-)) cuprate (4-)]
EC number: 943-486-8 | 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 its modification under Prival (NONS dossier, 1991). Different strains at concentrations ranging from 10 to 5000 ug/plate were tested with and without S9 mix showing no potential for gene mutation.
Moreover an in vivo test following OECD 474 (NONS dossier, 1991) showed that no change in the ratio P/N was determined after 24, 48 and 72h oral exposure of mice to the tested substance.
Based on the read across considerations same results apply to Direct Blue 267:1
Short description of key information:
Ames test, with and without S9 mix, 10 to 5000 ug/plate: negative
Ames test, Prival modification, with and without S9 mix, 10 to 5000 ug/plate: negative
in vivo micronucleus, P/N ratio not changed
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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