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Key value for chemical safety assessment

Additional information

Justification for selection of genetic toxicity endpoint
GLP compliant studies conducted in accordance with international guidelines.

Short description of key information:
AMES STUDY:
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A study according to OECD Guideline 471 (Bacterial Reverse Mutation Assay), EU Method B.13/14 and EPA OPPTS 870.5100 was carried out in year
2005.
Under the conditions of this study, DMAA showed no evidence of mutagenicity in the Bacterial Reverse Mutation Test either in the presence or absence of Aroclor-induced rat liver S9. The test substance was concluded to be negative in this study.

CHROMOSOME ABERRATION:
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The chromosome aberration test was performed in the year 2005/2006 according to OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test), EU Method B.10, EPA OPPTS 870.5375 and GLP. All criteria for a valid study were met. Under the conditions of this study, DMAA was not found to induce structural or numerical chromosome aberrations in the in vitro mammalian chromosome aberration test in Chinese hamster ovary cells ineither the non-activated or S9 activated systems. It was concluded that the test substance was negative in this in vitro test.

HPRT ASSAY:
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The in vitro Mammalian Cell Gene Mutation Test: HPRT Assay was performed in year 2013 according to OECD Guideline 476, EU Method B.17, EPA OPPTS 870.5300 and GLP. LZ705 tested up to the maximum recommended concentration of 5000 μg/mL, with and without mammalian metabolic activation system and tested over a 5 hour period without metabolic activation did not induce increases in mutant frequency over the background (negative solvent control) in this in vitro test in Chinese hamster ovary cells. LZ705 tested without metabolic activation (S9-mix) over a prolonged treatment period (20 hours) did not induce statistically and biologically significant increases in mutant frequency. It is concluded that the test item, LZ705, was not mutagenic in this in vitro mammalian cell gene mutation test performed with in Chinese hamster ovary cells.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the data available the substance is not classified according to Regulation 1272/2008/EEC (CLP) and according to Directive 67/548/EEC (DSD).

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