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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

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

Constituent 1
Chemical structure
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

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