Registration Dossier
Registration Dossier
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EC number: 407-250-3 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The genotoxic potential of the test substance was investigated in-vitro and in-vivo.
The positive response in the Ames Test is assessed as false-positive. This is justified by the clear negative results in two subsequently performed Ames Tests (one standard protocol, one modified version for azo dyes) and the absence of any genotoxic or mutagenic response in an HPRT-gene mutation assay in-vitro as well as an UDS-assay performed in-vivo.
It is widely accepted that the metabolic conditions of the standard Ames test protocol are not appropriate for testing azo dyes for mutagenic activity in Salmonella typhimurium. Instead,a specific protocol should be followed to reduce the azo compounds to free amines. The conversion of the parent compound by azo-reduction in vivo results in the formation of sulphonated arylamines as well as unsulphonated aromatic amines that may not be formed in the standard in vitro genotoxicity tests. There is evidence of sulphonated aromatic amines not being associated with genotoxicity in vitro and in vivo. In contrast to their unsulphonated analogues they have no or very low genotoxic potential. Hence it was concluded that exposure to sulphonated aromatic amines are unlikely to induce any significant genotoxic risk.
The in-vitro chromosome aberration test in V79 chinese hamster cell line revealed a slight increase of chromosomal aberrations by the test article compared to controls. The subsequently conducted in-vivo micronucleus test however was devoid of a genotoxic response.
The studies were found to be adequate to fufill the purposes of this endpoint.
Short description of key information:
in-vitro: positive in Ames Test with Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and 1538 (with and without microsomal activation)
in-vitro: negative in Ames Test with Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and 1538 and E.coli Wp2 (with and without microsomal activation)
in-vitro: negative in Prival-Ames with Salmonella strains TA 98, TA 100
in-vitro: negative in hprt-gene mutation assay in Chinese Hamster V79 cells
in-vivo: negative in micronucleus assay in Chinese Hamster bone marrow cells
in-vivo: negative in Dominant Lethal Study in mice
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
There are multiple and conclusive data to prove that classification of the test substance with regard to mutagenicity is not indicated.
The substance is not classified for this endpoint in accordance to Directive 67/548/EEC or the CLP Regulation (EC) No 1272/2008
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