Ephedrine

Endpoint summary

Additional information

The substance was tested for its mutagenic potential based on the ability to induce point mutation in several strains of Salmonella typhimurium (TA 98, TA 100, TA102) in a reverse mutation assay (NTP 2007). An increase in the number of his+ revertants was not observed in the preincubation test either without S9 mix or after the addition of a metabolizing system. It was therefore concluded that the test substance is not mutagenic under these experimental conditions.

In addition, three bacterial reverse mutation studies performed with three different structural analogues of ephedrine are available. The mutagenicity of (-)-Norephedrin S krist has been tested with4 Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, and TA 100) and one E. Coli strain (WP2 uvrA) in astandard plate test and apreincubation test (BASF 2000). The mutagenicity of (+)-Pseudoephedrin-HCl has been tested with 4 Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, and TA 100) inastandard plate test and apreincubation test (BASF 1991). The mutagenicity of ephedrine sulfate has been tested with fourstrains of Salmonella typhimurium (TA 1535, TA 100, TA98, TA 97) in apreincubation test (NTP 1986). In none of these studies an increase in the number of revertants was observed either without S9 mix or after the addition of a metabolizing system.

In the study performed with ephedrine, Salmonella typhimurium strains TA 98, TA 100, TA102 were used. In accordance with OECD Guideline 471, mutagenicity in bacteria should also be tested in Salmonella typhimurium strain TA1535, and TA1537 or TA97. In the studies performed with the three analogues of ephedrine no mutagencity was observed in these Salmonella strains. It was therefore concluded that these test substances are not mutagenic and as a result ephedrine is considered to be not mutagenic.

Short description of key information:
It is concluded that there is no evidence of induction of gene mutations by the test substance and its metabolites in the three S. typhimurium strains used in this study. In addition three bacterial reverse mutation studies are available, performed with three different structural analogous of ephedrine. These three structural analogues: (-)-Norephedrin S krist, (+)-Pseudoephedrin-HCl, and ephedrine sulfate do not induce the number of revertants either without S9 mix or after the addition of a metabolizing system. Overall as no mutagenicity was observed in the Ames test for the ephedrine and the structural analogues, ephedrine is considered to be not mutagenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Ephedrine and the structural analogues of ephedrine: (-)-Norephedrin S krist, (+)-Pseudoephedrin-HCl, and ephedrine sulfate are all non-mutagenic in the different Ames tests performed. Based on this, classification for genetic toxicity is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.