No reports of ginger-induced developmental toxicity
have been located.
Most of the substitutions involved replacing in vivo CAD tests with in vitro assays and using combined protocols (TG 421 or TG 422) to evaluate reproductive and/or developmental toxicity
, with or without repeated dose toxicity.
The drug caused developmental toxicity
(embryolethality, impaired growth, and birth defects) in animals during all portions of pregnancy.
Development of Repeated Dose Toxicity Testing In Vitro 36 CARCINOGENICITY AND GENOTOXICITY 36 INTRODUCTION 36 IN VITRO METHODS: BACKGROUND AND RECENT DEVELOPMENTS 36 REGULATORY VERSUS DRUG DEVELOPMENT APPLICATIONS 37 THE AMES TEST 37 IN VITRO MICRONUCLEUS TEST (MNT) 38 EFFORTS TO REDUCE FALSE POSITIVES 38 EXAMPLE OF RECENT INNOVATIONS 38 FUTURE CHALLENGE: NONGENOTOXIC CARCINOGENS 39 REPRODUCTIVE AND DEVELOPMENTAL TOXICITY
40 BACKGROUND 40 FOLLOWING THE REPRODUCTIVE CYCLE 40 Embryotoxicity 41 FEMALE REPRODUCTIVE TOXICITY 41 MALE REPRODUCTIVE TOXICITY 41
OBJECTIVES: To begin characterizing the potential toxicity of CPEs on early vertebrate development, we examined the developmental toxicity
of four CPEs used in polyurethane foam: tris(1,3-dichloro-2-propyl) phosphate (TDCPP), tris(2-chloroethyl) phosphate (TCEP), tris(1-chloro-2-propyl) phosphate (TCPP), and 2,2-bis(chloromethyl)propane-1,3-diyl tetrakis(2-chlorethyl) bis(phosphate) (V6).
All available data suggest that there is no indication for phototoxicity, acute toxicity, systemic toxicity (after repeated application), developmental toxicity
, genotoxicity or carcinogenicity.
The frog embryo teratogenesis assay-Xenopus (FETAX) was used to assess the developmental toxicity
The drug does not appear to represent a significant risk for developmental toxicity
Specific topics include the reproductive toxicity of mercury, cadmium, and arsenic; reproductive and developmental toxicity
of organotin compounds; adverse effects of aluminum, uranium, and vanadium on reproduction and intrauterine development in mammals; intrauterine and reproductive toxicity of nutritionally essential metals; lead exposure and its effects on the reproductive system; impact of metals on ovarian function; epidemiological and occupational studies of metals in male reproductive toxicity; and use of metal reproductive toxicity data in selecting ecological toxicity reference values for small mammals inhabiting hazardous waste sites.
The coverage includes epigenetic mechanisms, gene expression, reproductive and developmental toxicity
, signal transduction, and transgenic animal models.
The safety of PVAP has also been evaluated in a definitive 90-day subchronic toxicity study, a developmental toxicity
study, and several genotoxicity tests; however, the results have not yet been published (DeMerlis CC, unpublished data).
In the above situations, with the exception of cocaine, the risk of any aspect of developmental toxicity
from appropriate doses and administration of local anesthetics appears to be rare or nonexistent.