Registration Dossier
Registration Dossier
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EC number: 940-436-7 | CAS number: 1354632-48-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The substance and/or its structural analogue was negative in the following tests:
1) Ames Test – salmonella & E.coli
2) In Vivo Mammalian Erythrocyte Micronucleus Test
Remazol-Goldgelb RNL was tested for mutagenicity with the strains TA 100, TA 1535, TA 1537, TA 1538, TA 98 of Salmonella typhimurium and Escherichia coli WP2uvrA.
The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. A dose range of 6 different doses from 4 µg/plate to 5000 µg/plate was used.
Control plates without mutagen showed that the number of spontaneous revertant colonies was similiar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies.
Toxicity: The test compound proved to be not toxic to the bacteria. 5000 µg/plate was chosen as top dose level for the mutagenicity study.
Mutagenicity: In the absence of the metabolic activation system, the test compound did not show a significant dose dependent influence in the number of revertants in any of the bacterial strains. Also in the presence of metabolic activation system, treatment of the cells with Remazol-Goldgelb RNL did not result in relevant increases in the number of revertant colonies.
Summarizing, it can be stated that Remazol-Goldgelb RNL is not mutagenic in these bacterial test systems neither with nor without exogenous metabolic activation at the dose levels investigated.
Short description of key information:
Summary of genetic toxicity
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Justification for classification or non classification
The above studies have all been ranked reliability 1 or 2 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and/or 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 genetic toxicity is therefore required.
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