Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

Information on environmental fate and pathyways, in particular on biodegradation, is deduced by read-across from studies for L-arginine.

L-arginine-HCl as such is not a natural constituent of peptides and proteins. L-arginine-HCL is the salt resulting from the reaction of the basic L-arginine with HCl. Due to is higher water solubility L-arginine-HCl is often preferably applied than L-arginine, in particular when bioavailability is desired property for the intended use.

L-arginine-HCl dissociates in aqueous solution to ionic L-arginine as well as H+and Cl-. The inorganic ions resulting from physiological concentrations are not of concern for toxicokinetics as the “background” concentration in the body is by magnitudes higher

In a GLP-guideline study L-arginine showed 100% degradation after 28 days and therefore can be considered as readily biodegradable. Thus, L-arginine-HCl can be considered as readily biodegradable, too.

Most studies are waived in accordance with REACH.

  • In accordance with Annex IX sections 9.2.1.2 to 2 and section 9.2.1.4 columns 2 simulation tests on the biodegradation in surface water or sediment as well as soil are therefore not necessary.
  • Also, a study on hydrolyses does not need to be conducted in accordance with REACH Annex VIII No. 9.2.2.1 column 2, the study does not need to be conducted if the substance is readily biodegradable.
  • According to REACH Annex VIII section 9.3.1 column 2, a study for bioaccumulation does not need to be conducted if the substance has low potential for bioaccumulation (log Kow < 3) and/or the substance and its degradation products decompose rapidly. Both conditions apply for L-arginine-HCl. Therefore and for reasons of animals welfare a study is not deemed necessary.
  • In accordance with REACH Annex VIII section 9.3.1. column 2 as well as REACH Annex IX section 9.3.3. column 2 the study on adsorption/desorption screening (required in section 9.3.1. column 1) does not need to be conducted as the substance has a low log Kow as well as the substance and its degradation products decompose rapidly. Adsorption to solid soil phase is not expected. From the water surface L-arginine-HCl will not evaporate into the atmosphere.