Registration Dossier
Registration Dossier
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EC number: 201-377-6 | CAS number: 81-81-2
Developmental toxicity / teratogenicity
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:
- 2 009
- 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:
- 1 992
- 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:
- 1 990
- 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:
- 1 983
- 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 substance name:
- Warfarin
- EC Number:
- 201-377-6
- EC Name:
- Warfarin
- Cas Number:
- 81-81-2
- Molecular formula:
- C19H16O4
- IUPAC Name:
- 4-hydroxy-3-(3-oxo-1-phenylbutyl)-2H-chromen-2-one
Constituent 1
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
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