Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Respiratory sensitisation

Endpoint conclusion
Additional information:

"7,16-Dioxa-2-azabicyclo[11.2.1]hexadec-1-en-8-one, 10-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-6-ethyl-4,5-dihydroxy-3,5,9,11,13,15-hexamethyl-12-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-, (1Z,3R,4R,5S,6R,9R,10S,11S,12R,13R,15R)-" is an intermediate of the antibiotic Azithromycin.

Justification for classification or non-classification

In patients receiving systemically administered azithromycin, serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in patients on azithromycin therapy. Although rare, fatalities have been reported. The potential for anaphylaxis or other hypersensitivity reactions should be considered based on known hypersensitivity to azithromycin when administered systemically.