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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
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 developmental 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:
Ten gravid rabbits were administered with 200 mg/kg p.o. during the organogenetic period, i.e. from gestation days VI to XVIII. A second group of ten rabbits, used as control, was treated with physiological saline. At the end of treatment all animals were sacrificed and cesarcean section was performed with a determination of the number of foetus, weight, macroscopic appearance and implantation sites. Subsequently, the foetus were sacrificed and stained with alizarin, after which they were examined for anomalies in the thoracic and abdominal lumen and the skeleton.
GLP compliance:
no
Remarks:
pre GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Details on test animals and environmental conditions:
Gravid rabbits

Administration / exposure

Route of administration:
oral: unspecified
Duration of treatment / exposure:
The test substance was administered during the organogenetic period, i.e. from gestation days VI to XVIII.
Doses / concentrations
Remarks:
Doses / Concentrations:
200 mg/kg p.o.
Basis:

No. of animals per sex per dose:
10 rabbits x group
Control animals:
yes
Details on study design:
Control group was dosed with physiological saline.

Examinations

Maternal examinations:
At the end of treatment all animals were sacrificed and cesarcan section was performed with a determination of the number of foetus, weight, macroscopic appearance and implantation sites.
Fetal examinations:
The foetus were sacrificed and stained with alizarin, after which they were examined for anomalies in the thoracic and abdominal lumen and the skeleton.

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
dose level:
Effect level:
200 other: mg/kg p.o.
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
The test substance does not have teratogenic action, the foetus were normal in weight, number and implantation sites, and the same applied to resorption or skeletral structure.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The test item did not show tetatogenic effects and/or developmental toxicity.
Executive summary:

Ten gravid rabbits were administered with 200 mg/kg p.o. during the organogenetic period, i.e. from gestation days VI to XVIII. A second group of ten rabbits was treated with physiological saline, as control.

At the end of treatment all animals were sacrificed and carcass section was performed with a determination of the number of foetus, weight, macroscopic appearance and implantation sites. Subsequently, the foetus were sacrificed and stained with alizarin, after which they were examined for anomalies in the thoracic and abdominal lumen and the skeleton. This revealed that the test substance does not have teratogenic action, the foetus were normal in weight, number and implantation sites, and the same applied to resorption or skeletral structure.

Conclusion

The test item did not show tetatogenic effects and/or developmental toxicity.