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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-292-1 | CAS number: 56-85-9
Endpoint summary
Administrative data
Description of key information
QSAR showed no skin sensitising potential of L-Glutamine. Furthermore, a GPMT of the analogous substance L-Alanyl-L-glutamine (CAS 39537-23-0; EC 475-290-9) according to OECD 406 is available. L-Alanyl-L-glutamine is not sensitising in this study.
Further, L-glutamine 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 and is a component found in skin and hair cosmetics. Based on the available information, there is no human or animal data that indicates L-glutamine to be a skin sensitiser. Considering the extensive, widespread dermal exposure to L-glutamine 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-glutamine having a no skin sensitisation potential.
Based on all the available information, it can be concluded that L-Glutamine does not have a skin sensitising potential.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- 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-Glutamine 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-glutamine acts as a skin sensitizing agent.
Further, L-glutamine 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 and is a component found in skin and hair cosmetics.
Based on the available information, there is no human or animal data that indicates L-glutamine to be a skin sensitiser. Considering the extensive, widespread dermal exposure to L-glutamine 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-glutamine 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-Glutamine does 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): Kontaktallergene.Erich-Schmidt-Verlag, Berlin
L-Glutamine is not sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Experience from the handling of L-glutamine 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 of L-glutamine in industrial and commercial surroundings strongly indicate that the substance is not sensitising via the respiratory route.
Justification for classification or non-classification
L-Glutamine is considered as non sensitising and does not trigger respective 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.
