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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
An old complete chronic toxicity study was performed and mentioned in monograph. No details about the test procedures and substance composition are available. The study was performed on the base form; further details about the read across approach in the endpoint summay.

Data source

Reference
Reference Type:
other: monograph
Title:
Fleming lysozyme. Biological Significance and therapeutic applications.
Author:
Barbara L., Pellegrini R.
Year:
1976
Bibliographic source:
Ed. Minerva Medica. 1976.

Materials and methods

Principles of method if other than guideline:
Rats weighing an average of 100 g were distributed in groups of 10 males and 10 females each received 500 mg/kg p.o., 5 days a week for 5 months. Further 10 males and 10 females were used as control and treated with physiological saline, p.o. At the end of treatment all animals were sacrificed.
GLP compliance:
no
Remarks:
pre GLP

Test material

Constituent 1
Reference substance name:
Lysozyme
EC Number:
232-620-4
EC Name:
Lysozyme
IUPAC Name:
Lysozyme

Test animals

Species:
rat
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: rats weighing an average of 100 g.

Administration / exposure

Route of administration:
oral: unspecified
Duration of treatment / exposure:
5 months
Frequency of treatment:
5 days a week
Doses / concentrations
Remarks:
Doses / Concentrations:
500 mg/kg p.o.
Basis:

No. of animals per sex per dose:
5 rats x sex x group
Control animals:
yes

Examinations

Sacrifice and pathology:
At the end of treatment all animals were scacrificed.

Results and discussion

Results of examinations

Body weight and weight changes:
no effects observed
Description (incidence and severity):
no differences between treated and control groups
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
no differences between the trated and control animals
Gross pathological findings:
no effects observed
Description (incidence and severity):
no particular changes
Details on results:
BODY WEIGHT AND WEIGHT GAIN
No weight differences were recorded in the treated groups in comparison with the control.

CLINICAL CHEMISTRY
Morphological blood studies revealed no differences between the trated and control animals.
Glycemia, azotemia and the serum proteins remained unmodified.

GROSS PATHOLOGY
Anatomical and histopatological examination of the lungs, heart, kydneys, liver and spleen showed no particular changes.

Effect levels

Dose descriptor:
dose level:
Effect level:
500 other: mg/kg p.o.
Sex:
male/female
Basis for effect level:
other: No adverse effects were reported in rats administered with 500 mg/kg p.o., 5 days a week for 5 months.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No adverse effects were reported in rats administered with 500 mg/kg p.o., 5 days a week for 5 months.
Executive summary:

Rats weighing an average of 100 g were distributed in groups of 10 males and 10 females each received 500 mg/kg p.o., 5 days a week for 5 months. Further 10 males and 10 females were used as control and treated with physiological saline, p.o.

At the end of treatment all animals were sacrificed.

No weight differences were recorded in the treated groups in comparison with the control. Morphological blood studies revealed no differences between the treated and control animals. Glyceamia, azotemia and the serum proteins remained unmodified.

Anatomical and histopatological examination of the lungs, heart, kidneys, liver and spleen showed no particular changes.

Conclusion

No adverse effects were reported in rats administered with 500 mg/kg p.o., 5 days a week for 5 months.