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EC number: 214-275-1
CAS number: 1119-34-2
Skin sensitization is the process
following the epicutaneous application of a substance to the skin which
results in an immunological response specific for this substance. Skin
sensitisation is also called "delayed contact hypersensitivity",
"contact hypersensitivity", "contact allergy" or "allergic contact
To behave as a contact allergen, a
substance must penetrate into the skin and react with proteins.
L-arginine-HCl dissociates under physiological conditions and is present
as L-arginine. L-arginine is a normal constituent of living cells as a
free amino acid, bound to RNA and incorporated in proteins and peptides.
Therfore, it is highly improbable that L-arginine and thus
L-arginine-HCL acts as a skin sensitizing agent.
Further, L-argine-HCl/ L-arginine is
used in parenteral nutrition, as a dietary supplement, in biochemical
research, in cell culture media, as a feed additive, as an excipient in
medicinal products, is a component found in skin cosmetics, is a
fragrance Ingredient and used as a hair conditioning agent.
Based on the available information,
there is no human or animal data that indicates L-arginine or
L-arginine-HCl to be a skin sensitiser. Considering the extensive,
widespread dermal exposure to L-arginine and L-arginine-HCl line in
preparations repeatedly applied to the skin or being in contact with the
skin, the absence of case reports of humans showing skin reactions is
consistent with L-arginine and L-arginine-HCl having a very low skin
Structural alerts for skin sensitisation
were derived in a database which classified as strong or moderate
sensitizers. These were the chemicals which would be classified
according to the criteria of the Dangerous Substance Directive
67/548/EEC. For the identification of structural alerts, the chemicals
were divided into groups, on the basis of reaction mechanisms or by
empirical derivation: a) acylating agents; b) alkylating/arylating
agents, c) "Michael" electrophiles and precursors; e) free radical
generators; d) aldehydes and precursors, f) "thiol-exchange" agents; and
g) others (empirical). Forty rules (structural alerts were identified
from these group of chemicals. (see: de Silva et al, 1996; Klaschka and
L-arginine or L-arginine-HCl do not
contain any of this structural alerts in its chemical structure.
In accordance with REACH Annex XI No.
8.3. column 1 the assessment of this endpoint shall comprise as the
first step an assessment of the available human, animal and other data.
These data reveal that in vivo testing is not required in accordance
with REACH and animal welfare.
de Silva D. et al (1996): Alternative
Methods for Skin Sensitisation testing. The report and recommendations
of ECVAM Workshop 19. ATLA 24, 683 - 705
Klaschka F. und Voßmann D. (1994):
Migrated from Short description of key information:
L-arginine-HCl dissociates under physiological conditions and is present as L-arginine. L-arginine is a normal constituent of living cells. L-arginine and thus L-arginine-HCl cannot be regarded as a skin sensizing agent.
Experience from the handling L-arginine-HCl in industrial and commercial
surroundings strongly indicate that the substance is not sensitising via
the respiratory route. Studies on this endpoint are not available.
Experience from the handling L-arginine-HCl in industrial and commercial surroundings strongly indicate that the substance is not sensitising via the respiratory route.
L-arginine-HCl is considered as non sensitising and does not trigger
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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