Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

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 dermatitis".

 

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 sensitisation potential.

 

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 Voßmann, 1994).

 

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.

 

Citations:

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): Kontaktallergene.Erich-Schmidt-Verlag, Berlin

 

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.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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.

Migrated from Short description of key information:

Experience from the handling L-arginine-HCl in industrial and commercial surroundings strongly indicate that the substance is not sensitising via the respiratory route.

Justification for classification or non-classification

L-arginine-HCl is considered as non sensitising and does not trigger respective classification.