9,10-Anthracenedione, 1,4-bis[(2-ethylhexyl)amino]-5,8-dihydroxy-

Endpoint summary

Additional information

The test article, Spectrace® MD-810 Marker (Solvent Free), was tested in the bacterial reverse mutation assay using Salmonella typhimurium tester strains TA98, TA100, TA1535 and TA1537 and Escherichia coli tester strain WP2uvrA in the presence and absence of Aroclor-induced rat liver S9. The assay was performed in two phases, using the plate incorporation method. The first phase, the initial toxicity mutation assay, was used to establish the dose-range for the confirmatory mutagenicity assay and to provide a preliminary mutagenicity evaluation. The second phase, the confirmatory mutagenicity assay, was used to evaluate and confirm the mutagenic potential of the test article.

Dimethyl sulfoxide (DMSO) was selected as the solvent based on solubility of the test article and compatibility with the target cells. The test article formed workable suspensions in dimethyl sulfoxide from 50 to 100 mg/rnL in the solubility determination.

In the initial toxicity-mutation assay, the maximum dose tested was 5000 μg per plate; this dose was achieved using a concentration of 100 mg/mL and a 50 μL plating aliquot. The dose levels tested were 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 μg per plate. The test article formed workable suspensions in DMSO from 1.0 to 100 mg/mL and soluble and clear solutions from 0.030 to 0.30 mg/mL. In the initial toxicity-mutation assay, no positive mutagenic response was observed. Precipitate was observed beginning at 50 μg per plate. No appreciable toxicity was observed. Based on the findings of the initial toxicity-mutation assay, the maximum dose plated in the confirmatory mutagenicity assay was 5000 μg per plate.

In the confirmatory mutagenicity assay, no positive mutagenic response was observed. The dose levels tested were 50, 150, 500, 1500 and 5000 μg per plate. Precipitate was observed beginning at 50 or 150 μg per plate. No appreciable toxicity was observed.

Under the conditions of this study, test article Spectrace® MD-810 Marker (Solvent Free) was negative in the bacterial reverse mutation assay (Ames test).

Short description of key information:
All criteria for a valid study were met. The results of the bacterial reverse mutation assay indicate that, under the conditions of ths study, Spectrace MD-810 Marker (Solvent Free) did not cause a positive response in either the presence or absence of Aroclor-induced rat liver S9.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Acccording to an OECD guideline 471 study Spectrace MD-810 Marker (Solvent Free) did not cause a positive response in either the presence or absence of Aroclor-induced rat liver S9.