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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
2009
Report Date:
2009
Reference Type:
secondary source
Title:
The warfarin embryopathy: a rat model showing maxillonasal hypoplasia other skeletal disturbances
Author:
Howe AM, Webster WS
Year:
1992
Bibliographic source:
Teratology 46, 379-390
Reference Type:
secondary source
Title:
Effect of sodium warfarin on vitamin K-dependent proteins and skeletal development in the rat fetus
Author:
Feteih R, Tassinari MS, Lian JB
Year:
1990
Bibliographic source:
J. Bone Miner. Res. 5, 885-894
Reference Type:
secondary source
Title:
Experimental evaluation of the risk of prenatal pathology with the application of the coumarine rodenticide warfarin
Author:
Mirkova E, Antov G
Year:
1983
Bibliographic source:
Hig. Zdrav. 25, 476-482

Materials and methods

Principles of method if other than guideline:
Method data are not available.

GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Route of administration:
subcutaneous

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Effect level:
0.04 mg/kg bw/day
Basis for effect level:
other: developmental toxicity
Effect level:
>= 0.04 - <= 8 mg/kg bw/day
Basis for effect level:
other: developmental toxicity
Effect level:
100 mg/kg bw/day
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes

Details on embryotoxic / teratogenic effects:
Haemorrhagic syndrome in foetuses, structural malformations of the hind limbs, internal hydrocephalus, metabolic damage of foetus livers (rat, repeated dose of 0.04 - 8 mg/kg bw/day); maxillonasal hypoplasia, calcium deposits in cartilage of the nasal septum and epiphyseal cartilage of vertebrae and long bones (rat, 100 mg/kg bw subcutaneous injection)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion