Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Several in vitro assays (Ames tests, a chromosome aberration test, a HGPRT assay, 2 SCE assays and several UDS/DNA repair assays) are published. Additionally an in-vitro micronuleus test in chinese hamster V79 cells according to OECD TG 487 was conducted.
No in vivo assay is available.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Description of key information

No in vivo assay is available.

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the Ames test, 1,4-dihydroxyanthraquinoe was positive (with the exception of those assays were only a limited number of S. typhimurium strains were used. 1,4-dihydroxyanthraquinone was also positive in the CA test and the in-vitro micronucleus test in Chinese hamster V79 cells.

In the HGPRT test and the UDS/DNA repair assays, 1,4-dihydroxyanthraquinone was negative, also in the genotoxicity assay in Saccharomyces cervesia. In the SCE assay, 1,4-dihydroxyanthraquinone revealed a weak (and dose independent) effect.

In 2 in vitro DNA binding assays a positive and a negative result was obtained (see section 7.9.3 specific investigations).




Justification for classification or non-classification

In the Ames tests, the chromosome aberration test and the in-vitro MNT a positive result was obtainded. In the HGPRT test and the UDS/DNA repair assays, 1,4-dihydroxyanthraquinone was negative, also in the genotoxicity assay in Saccharomyces cervesia. In the SCE assay, 1,4-dihydroxyanthraquinone revealed a weak (and dose independent) effect.

In 2 in vitro DNA binding assays a positive and a negative result was obtained (see section 7.9.3 specific investigations).

Overall, 1,4-dihydroxyanthraquinone was positive in several in-vitro assays, but no in-vivo studies are available. Based on the inconclusive results a classification according to CLP classification criteria (Regulation (EC) No 1272/2008) is not suitable, however due to the ambigouos results 1,4-dihydroxyanthraquinone is allocated to the medium hazard band.