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EC number: 214-275-1
CAS number: 1119-34-2
Read across from L-arginine to L-arginine-HCl is performed.
L-arginine did not exhibit genetic toxicity in several in vitro GLP guideline studies:
- OECD 473 (In vitro Mammalian Cell Chromosome Aberration) (2 studies)
- OECD 471 (Bacterial Reverse Mutation Assay; Ames test) (2 studies).
In summary, L-arginine-HCl is not considered to be genotoxic.
Additional information from genetic toxicity in vitro:
Read across from L-arginine to L-arginine-HCl is justified for
genetic toxicity, too. L-arginine-HCl is present as L-arginine under
physiological conditions and in human body fluids.
L-arginine was tested for genetic toxicity in a total of 4 in
vitro GLP guideline studies, 2 of them were the bacterial reverse
mutation assay, 2 of them were mammalian cell chromosome aberration
tests. Neither the Ames-test (OECD 471) nor the mammalian cell
chromosome aberration test (OECD 473) did exhibit any genetic toxicity.
These results were foreseeable as L-arginine is a naturally
occurring amino acid. L-arginine is a normal constituent in living cells
occurring as a free amino acid, bound to RNA and incorporated in
proteins and peptides. It is ingested daily in significant amounts.
Therefore human exposure through food is orders of magnitude higher than
the anticipated levels of exposure from the uses covered by this
dossier. L-arginine is present in significant amounts in human body
fluids – e. g. human blood plasma (Cynober 2002) - as well as in human
cells. It is a basic metabolite and building block of all living
organisms and therefore a genotoxic/mutagenic potential could be
Cynober L (2002): Plasma Amino Acid Levels With a Note on Membrane
Transport: Characteristics, Regulation, and Metabolic Significance.
Nutrition 18 (9), 761-766
Justification for selection of genetic toxicity endpoint
An additional key study referring to the endpoint 8.4.1 of REACH Annex VII is: 2148/001.
L-arginine is negative in several in vitro mutation tests.
Furthermore, as L-arginine is a ubiquitously occurring substance in
food, the environment and even in human body fluids there is no concern
with respect to mutagenicity. By means of read across it is concluded
that L-arginine-HCl should not be classified as a mutagen (as a germ
cell mutagen in the wording of CLP).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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