Pseudoephedrine hydrochloride

Endpoint summary

Additional information

An Ames Test (OECD TG 471, GLP) is available where the tester strains Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 were used to examine the mutagenic potential of the test substance up to concentrations of 5000 µg/plate in a standard plate test a preincubation test with and without metabolic activation (BASF 1991). Neither cytotoxic nor genotoxic effects have been observed, thus the test substance possessed no mutagenic potential in the bacterial system used.

In addition, two bacterial reverse mutation studies performed with two different structural analogues of pseudoephedrine hydrochloride are available. The mutagenicity of (-)-Norephedrin S krist has been tested with 4 Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, and TA 100) and one E. Coli strain (WP2 uvrA) in a standard plate test and a preincubation test (BASF 2000). The mutagenicity of ephedrine sulfate has been tested with four strains of Salmonella typhimurium (TA 1535, TA 100, TA98, TA 97) in a preincubation 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 pseudoephedrine hydrochloride, Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 were used. In accordance with OECD Guideline 471, mutagenicity in bacteria should also be tested in Salmonella typhimurium strain TA102 or E.coli WP2. In the studies performed with the two analogues of pseudoephedrine hydrochloride no mutagencity was observed in these Salmonella and E.coli strains. It was therefore concluded that these test substances are not mutagenic in bacteria and as a result pseudoephedrine hydrochloride is considered to be not mutagenic to bacteria.

Justification for selection of genetic toxicity endpoint
One Genetic toxixity study is available. This study is adequate for covering this endpoint.

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 four S. typhimurium strains used in an OECD 471 guideline study. In addition two bacterial reverse mutation studies are available, performed with two different structural analogous of pseudoephedrine hydrochloride. These two structural analogues: (-)-Norephedrin S krist, and ephedrine sulphate do not induce the number of revertants either without S9 mix or after the addition of a metabolizing system. It was therefore concluded that pseudoephedrine hydrochloride is not mutagenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Pseudoephedrine hydrochloride and the structural analogues of pseudoephedrine hydrochloride: (-)-Norephedrin S krist, 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.