Registration Dossier
Registration Dossier
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EC number: 205-153-9 | CAS number: 134-71-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Three bacterial reverse mutation studies performed with three different structural analogues of (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol 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 (+)-Pseudoephedrin-HCl has been tested with 4 Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, and TA 100) in a standard plate test and a preincubation test (BASF 1991). 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. It was therefore concluded that these test substances are not mutagenic and as a result (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride is considered to be not mutagenic.
Short description of key information:
Three bacterial reverse mutation studies are available, performed with three different structural analogous of (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride. 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. It was therefore concluded that these test substances are not mutagenic and as a result (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride is considered to be not mutagenic.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
(-)-Norephedrin S krist, (+)-Pseudoephedrin-HCl, and ephedrine sulfate are all structural analogues of (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride. Because all three substances are non-mutagenic it is suspected that (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride will also be non-mutagenic. 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.
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