Registration Dossier
Registration Dossier
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EC number: 461-870-9 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The results are read across from the free acid form. Read across is applicable based on the content of sodium ions. The presence of these is determined by the pH of the isolation of the dyestuff itself. Therefore the substance to be registered is deemed to be a mixture of free acid, mono and di sodium salts. Upon comparison of the NMR-Spectra of the substance to be registered and the read across chemical it is evident that the chemical shifts as well as the integrations are the same, hence it is difficult to quantify free acid, mono and di variants. The CAS number proposed for the substance to be registered covers the sodium element. The associated free acid has a unique CAS number; this is referenced in the substance identity, as does the disodium variant, which is also referenced.
The substance was negative in the following tests:
1) Ames Test - salmonella
2) Prival Test - salmonella
3) In vitro chromosome aberration test – human lymphocytes
The bacterial reverse mutation tests, showed that the substance does not have any mutagenic properties in different Salmonella and E. Coli strains. In addition, no genotoxic properties have been seen in the in vitro chromosome aberration test. Repeat-dose studies with oral treatment in rats did not reveal any tumorigenic properties which could be related to the administration of the test substance.
Short description of key information:
No genotoxic effects were noted in in-vitro mutagenicity and clastogenicity studies.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for prolonged effects is therefore required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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