L-(+)-2,5-diaminopentanoic acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

Further, L-(+)-2,5-diaminopentanoic acid L-ornithine might be 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 and related products.

Based on the available information, there is no human or animal data that indicates L-ornithine or L-(+)-2,5-diaminopentanoic acid to be a skin sensitiser. Considering the extensive, widespread dermal exposure to L-ornithine and L-(+)-2,5-diaminopentanoic acid 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-ornithine and L-(+)-2,5-diaminopentanoic acid having no skin sensitisation potential.

L-ornithine or L-(+)-2,5-diaminopentanoic acid 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