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Ames tests are negative for Malachite Green (MG). In Fessard et al. (1999) study results show an higher cytotoxicity of MG: it had no mutagenic activity in any bacterial strains, with and without metabolic activation, for doses at or lower than 10 µg per plate. In Clemmensen at al (1984) cell toxicity was usually encountered at 1.28 µg/plate unless S-9 was added. In TA 98 there was no increase without metabolic activation, but a significant increase was seen in the three highest doses after addition of S-9, nevertheless these doses are well above the citotoxicity level and the consideration is of doubtful relevance.

In the study of Fessard et al. (1999) MG was found to be extremely cytotoxic to mammalian cells (CHO) in culture and study confirmed also that MG induced DNA alterations only at cytotoxic doses.

In another study on chromosomal aberration (Au et al., 1979) MG did not show a relevant number of brakes for metaphase.

In the in vivo study of Clemmensen (1984) no significant increase in the number of micronuclei in bone marrow smears of mice treated by gavage with a single dose of 37.5 mg/kg bw was observed.

In the study of Mittelstaedt (2004), gene mutations in transgenic Big Blue B6C3F1 mice was investigated. In female Big Blue mice fed up to 408 ppm Leucomalachite Green (LG) or 450 ppm MG chloride for 16 weeks, the ceII mutant frequency was significantly increased in the liver of mice exposed to LG, but not MG chloride. In the same study, neither MG nor LG increased the peripheral blood micronucleus frequency or Hprt lymphocyte mutant frequency in female mice. The results of this study suggest a correlation between the mutagenicity of LG and its tumorigenicy in mice and rats.

 

In conclusion MG was found to be cytotoxic. Tests in vitro and in vivo on genetic toxicity of MG are in general negative up to the cytotoxicity level.

 

Despite some results are not conclusive, there is not enough evidence to consider MG genetoxic according to CLP classification.

Short description of key information:

Not mutagen

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to CLP regulation (EC1272/2008) Malachite Green Acetate is not classified as mutagen