Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-678-6 | CAS number: 3184-13-2
Endpoint summary
Administrative data
Description of key information
The substance does not require C&L as sensitising properties are not to be expected.
Key value for chemical safety assessment
Skin sensitisation
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-(+)-2,5-diaminopentanoic acid is present as L-ornithine under physiological conditions. L-ornithine 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-ornithine and thus L-(+)-2,5-diaminopentanoic acid acts as a skin sensitizing agent.
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 a very low 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
Justification for classification or non-classification
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.
