Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

According to the REACH Regulation, Annex VIII, Column 1 Standard information required, the assessment of the toxicokinetic behaviour of the substance can be derived from the relevant available information. The lysozyme enzyme has been widely studied, thus the available information can be used to trace the toxicokinetic behaviour, avoiding further tests.

Lysozyme was first discovered by A. Fleming, who identified lysozyme as an antibacterial enzyme present in nasal mucus membrane. Luce and Pellegrini (1976) have reported in a handbook the conclusions reached by Fleming.


Lysozyme is inactivated by stomach and intestinal proteolytic enzymes, particularly pepsin, rendering it harmless to humans on ingestion (GRAS Notice, 2000; FDA, 2001).

The absorption by lymphatic route is negligible.


Lysozyme is eliminated by the renal route. In general, enzymes do not accumulate in tissues and organs.


Barbara L. and Pellegrini R. (1976). Fleming's Lysozyme. Edizioni Minerva Medica, 1976 pp.58-65.

Food and Drug Administration (FDA) (2001). Agency Response Letter GRAS Notice No. GRN 000064. April 2, 2001.

GRAS notice for lysozyme (2000). No. 000064. Rhodia, Inc.