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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Lysozyme is expected to have no adverse local/systemic effects for repeated exposure.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SUB-ACUTE TOXICITY

No data on oral/inhalation/dermal routes are available.

In the Luce and Pellegrini handbook [1] was reported that published data referred to a period of 21 [2] days and 10 days [3], respectively, are available.

Lysozyme showed little toxicity even after medium-term administration in high doses, such as in rats treated for 10 days with 1 g/kg i.p.. The guinea pigs and rabbits tolerated intramuscular doses of 100 mg/kg for 10 days without symptoms or local tissue.

CHRONIC TOXICITY

In a study dogs [1] were treated for 5 days/week, for 12 months with 100 and 500 mg/kg p.o and with 25 and 50 mg/kg i.v. As for the local tolerance, no signs of intolerance or tissue reactions were observed. The haematological and blood chemistry data (RBC, WBC, Hb, platelets, differential WBC, haematocrit, clotting time, total serum proteins, bilirubinemia, cholosterolemia, alkaline phosphatase, transaminases) did not deviate from normal in the treated and untreated animals and the same applies to the parameters of liver and kidney function. Furthermore in the post mortem examination, the weight of the individual organs confirmed the optimum tolerance of lysozyme and analogous conclusions could be deduced from the histological reports.

In the handbook of Luce and Pellegrini [1] were also reported results indicating no toxicity on rats administrated p.o. and that the data available egg white lysozyme is devoid of toxic effects even after rather prolonged administration (referred to chronic toxicity in rats and dogs).

No data of sub-acute, nor chronic toxicity on inhalation and dermal route are available. Nevertheless the nature of the substance and the data available on oral route lead to the conclusion that Lysozyme can be expected to have no adverse local/systemic effects for repeated exposure.

Reference

[1] Luce Barbara, Pellegrini Rinaldo, “Fleming lysozyme. Biological Significance and therapeutic applications”. Ed. Minerva Medica. 1976

[2] Sangiorgi G. “Sulla tossicità del losozima da albume d’uovo, iniettato per diverse vie.” Boll. Soc. Ital. Biol. Sperim. 28, 1017, 1952

[3] Gialdroni Grassi G. “Ricerche farmacologiche sul lisozima”. Terap. Antib, Chemioter. 6, 89, 1956.

Justification for classification or non-classification

According to CLP regulation (EC1272/2008) Lysozyme is not classified for repeated dose toxicity.