6-aminopenicillanic acid

Endpoint summary

Additional information

In vitro gene mutation in bacteria:

Mutagenic activity of 6-Aminopenicillanic acid was not observed. The study was considered sufficient to fulfil the standard information requirement 8.4.1 in vitro gene mutation study in bacteria. The additional E. coli cross linking strain is anticipated to have no impact on the final conclusions of the study.

In vitro cytogenicity in mammalian cells:

The test material did not induce a toxicologically significant increase in the frequency of cells with chromosome aberrations in either the absence or presence of a liver enzyme metabolising system. The test material was therefore considered to be non-clastogenic to human lymphocytes in vitro.

In vitro gene mutation in mammalian cells:

The test material did not induce any toxicologically significant increases in the mutant frequency at the TK +/- locus in L5178Y cells and is therefore considered to be non mutagenic under the conditions of the test.

Short description of key information:

In vitro gene mutation in bacteria was determined by a  GLP study comparable to current guidelines with the exception of the missing E.coli strain (OECD Guideline 471 (Bacterial Reverse Mutation Assay).

In vitro cytogenicity in mammalian cells was determined by a GLP study conducted to current accepted guidelines (OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test).

In vitro gene mutation in mammalian cells was determiend by a GLP study conducted according to current accepted guidelines (OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test).

Endpoint Conclusion: No adverse effect observed (negative)