Reproductive toxic effects fetus

A BLW is used when a BAT value carmot be established, as for carcinogenic or suspected carcinogenic substances. The BLW for lead is 40 pg/dL for all men and women older than 45 years old and 10 pg/dL for women younger than 45 years old. The bases for those values are the prevention of neurotoxic effects and minimization of reproductive toxic effects (DFG 2005). Lead and its inorganic compounds are considered to be in pregnancy-risk group B, which indicates probable risk of damage to an embryo or fetus even when the BLW is observed... 

Reproductive toxicity of acesulfame K was studied in test systems aimed at detecting teratogenicity, oral embiyotoxicity and in a multigeneration study. No teratogenicity, no embryotoxicity, and no effects on reproduction, development of the fetuses and lactation performance were found.7... 

Reproductive effects at the time of the incident included a 44% loss of fetuses in 865 pregnant women (15% expected), and the neonatal death rate increased from 3% to 15%. Reproductive toxicity of MIC has been confirmed in animal studies exposure has caused increased resorptions, reduced pup weight, and reduced neonatal survival. Terato-logical anomalies including wrist drop, everted claw, syndactyly, cleft palate formation, and unequal ribs were observed in rats exposed to concentrations of up to 0.353 ppm during gestation. ... 

Couri et al. (1982b) reported an increase in the number of resorbed and dead fetuses in cesarean-delivered litters of pregnant rats receiving chlorite doses 70 mg/kg/day during gestation. However, this may have been a developmental toxicity effect. Additional reproductive toxicity studies could be designed to further investigate the potential for chlorine dioxide or chlorite to induce reproductive effects. 

Vertebral resistance to a crushing force was increased by about 10% at all boron dose levels (200-9000 mg B/kg ration) no effect on femurs and tibias. Dietary loadings of 3000 and 9000 mg/kg were reproductively toxic to males and the developing fetus (31)... 

Developmental Toxicity. No developmental toxicological studies were located in the surveyed literature for HDI. It is not known if HDI exerts an effect on reproductive tissues in males or females or on the developing fetus however, given its short half-life in biological fluid, this seems imlikely. HDI has been reported to bind to biological tissues (protein) (Ted and Pesce 1979) however, the relevance of this observation to reproductive toxicity is not known. The toxicity of the HDI metabolite (HDA) is not known. Toxicologic studies should be devised to answer questions about HDI s potential developmental toxicity or its prepolymers in the developing human or laboratory animal. 

Toxicology, including an integrated summary of toxicological effects of the drug, including results from acute, subacute, chronic, and in vitro toxicity tests, the effects on reproduction and the fetus and special toxicity tests. A detailed tabulation of toxicity data for each study should be included. 

Both V(IV) and V(V) have been found to have reproductive and developmental toxic effects in rodents. In addition to decreased fertility, lethal effects to embryos, toxicity to fetuses, and teratogenicity have been observed in mice, rats, and hamsters exposed to vanadium.3... 

Reviews of the results from the reproductive toxicity testing for the approved monoclonal antibody biopharmaceuticals have shown very few incidences of harm to fetuses. The only notable effects that have been observed are hematologic changes in macaque fetuses exposed to natalizumab, skeletal abnormalities in rabbit fetuses exposed to bevacizumab, and immunological deficits in mice exposed to the efalizumab murine surrogate. In each of these examples the effects seen in the fetuses were predicable based on effects seen in the adult animals. 

In reproductive studies, effects on the fetus have been seen only at oral doses that were associated with concurrent maternal toxicity. In an inhalation study conducted by Biodynamics, pregnant female rats were exposed to mixed xylenes 6hday for 190 days. Toxicity to the fetus was apparent in the group exposed to 500 ppm. Rat pups born to dams exposed to 500 or 250 ppm displayed reduced weight of ovaries, but the effect was transient. Developmental toxicity was seen in another inhalation study in rats. 

Toxic infertility as used here refers to adverse effects on the reproductive systems of human males and females that result from exposure to xenobiotic single chemicals and chemical mixtures. This infertility may be because of direct toxic effects on the male or female reproductive organs and endocrine systems, or on the developing fetus such that the fetus cannot be either conceived or carried to term after conception. Developmental toxicity, the onset of adverse effects on the developing fetus or child after birth are discussed in Chapter 24. 

Reproductive Toxicity. At a dose range without toxic effects to the maternal oiganism, the following influences could be observed Increase in embryo lethality decrease in ossification of bones tungsten accumulation in the fetus no significant retention in die placenta. 

---