The effect of flunitrazepam on reproduction in the rat. The use of cross-fostering in the evaluation of postnatal parameters in rat reproduction studies.
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Animals↗
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Results for “Reproductive parameters”
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The effect of intragastric administration of delta 9-tetrahydrocannabinol on the growth and development of fetal mice of the A/J strain.
Pregnant A/J mice were intubated with vehicle (sesame oil:Tween 80:water) or 60, 120, or 240 mg/kg of delta 9-tetrahydrocannabinol on Days 11 and 12, 12 and 13, or 13 and 14 (vehicle and 240 mg doses only) of gestation. Mice were killed on Day 20 of gestation, and examined for number of corpora lutea and live and resorbed fetuses. Fetuses were weighed and examined for gross external and internal malformations. Each treatment group consisted of a minimum of 10 litters with about 10 pups per litter. In a few groups the effects of feed deprivation on Day 12 or of glucocorticoid administration on Days 12 and 13 (positive control) were assessed. Intubation with vehicle or delta 9-tetrahydrocannabinol, or feed deprivation did not affect number of live fetuses, incidence of resorption, fetal weights, or gross malformations other than cleft palate. Intubation of delta 9-tetrahydrocannabinol on gestational Days 12 and 13 or 13 and 14 increased the mean frequency of cleft palate formation. The increase was 2- to 2.5-fold at the 240-mg dose, being significant (p = 0.05) in the Days 12 and 13 group. Cortisone acetate and corticosterone injection induced both resorption and cleft palate formation. Other developmental or reproductive parameters were not influenced by delta 9-tetrahydrocannabinol treatment. We conclude that delta 9-tetrahydrocannabinol administered by gavage during Days 12 and 13 of gestation retards normal palatal development.
Administration, Oral↗
Antifertility effect of busulfan and DL-6-(N-2-pipecolinomethyl)-5-hydroxy-indane maleate (PMHI) in coyotes (Canis Latrans ).
Antifertility effects of busulfan were evaluated using adult coyotes. In addition, antifertility effects of PMHI were evaluated in adult males. Adult males and females were alloted randomly to the following treatments: (1) untreated control, (2) a single oral dose of 3 mg busulfan/kg of body weight (BW) or (3) two oral doses of 3 mg busulfan/kg BW given nine days apart. The untreated males were used as controls in both experiments. Additional male coyotes were allotted randomly to PMHI treatments as follows: (1) a single oral dose of 2 mg PMHI/kg BW, or (2) two oral doses of 1 mg PMHI/kg BW given seven days apart. Blood samples were taken from females and serum analyzed for progesterone by radioimmunoassay. Males were hemicastrated (left testicle) 30 days after onset of treatment. The right testicle was removed 30 days later. Testes and epididymides were fixed in 10% buffered formalin and prepared for histologic examination. For females developing corpus luteum (CL), the maximum peak progesterone concentration for those given two doses of busulfan was less (P<0.05) than that for untreated controls and single-dose females (16.9, 22.4 and 26.3 ng/ml, respectively). The double treatment of busulfan prevented more females (4 of 10) from developing CL (P<0.08) than controls (0 of 7) or single-dose females (1 of 9). None of the busulfan-treated male coyotes had histologic evidence of spermatogenesis 60 days after the onset of treatment. The oral dose or doses of PMHI did not result in complete degeneration of seminiferous tubules. Busulfan given orally did not cause any adverse reactions, but orally administered PMHI often induced vomiting within 18 min after treatment. We conclude that busulfan is capable of affecting male and female reproductive parameters, but PMHI appears to have little effect on spermatogenesis in coyotes when given orally in a single- or a double-dose.
Journal Article↗
Incidence and treatment of abnormal postpartum ovarian function in dairy cows.
The objectives of this study were to determine 1) the incidence of abnormal postpartum ovarian function in a large dairy herd in North Central Florida and 2) the effectiveness of gonadotrophin releasing hormone (GnRH) in treating this condition. The study was conducted from April 1988 to June 1989. The internal genitalia of the cows were initially examined per rectum (Day 0) between 19 and 29 (23 +/- 0.25) d after calving and again 14 d later (Day 14) for evidence of uterine involution and ovarian activity. The presence of a palpable corpus luteum (CL) and retrospective determination of plasma progesterone (P4) concentrations > 1 ng/ml were the criteria used to assess ovarian activity. Cows possessing a palpable CL and P4 concentrations > 1 ng/ml on Day 0 were determined to be cycling normally. A total of 1356 cows was used in this study. On Day 0, two groups were formed: Group 1 consisted of normal, cyclic cows, Group 2 of noncyclic cows. On Day 0, alternate cows in Group 2 were treated with GnRH (100 microg i.m). On Day 14, the previously nontreated cows in Group 2 were further divided into two groups, forming Group 3, nontreated cows and Group 4, cows treated with GnRH at this time. Group 5 was comprised of cows from Group 2 that did not respond to treatment with GnRH on Day 0; these cows were treated on Day 14 with GnRH (100 microg i.m). Group 6 was comprised of nontreated cows from Group 2 that responded spontaneously (presence of a CL) by Day 14. Reproductive parameters evaluated were the percentage of cows pregnant within 180 d after calving and at the end of the study, the number of days open and the number of services per conception. Data were statistically analyzed using Chi square and survival analysis. The results of this study indicate that the incidence of abnormal postpartum ovarian function in this herd was 30.2% and that the nontreated cows experienced more days open and required more services per conception than the treated cows, those that were cycling normally on the initial examination, and those that responded spontaneously by Day 14.
Journal Article↗
Marihuana-induced embryotoxicity in the rabbit.
Few teratogenic studies in animals have been performed simulating marihuana smoking in man. An inhalation marihuana teratology study was conducted in albino rabbits utilizing a modified automatic smoking machine originally developed for rats and mice. Appropriate numbers of dams were exposed to 4 puffs (0.14 mg/kg), 8 puffs (0.72 mg/kg), or 16 puffs (1.44 mg/kg) once daily during gestation Days 6 to 18, and sacrificed on Day 28. Control dams were exposed to 12 puffs of placebo cigarettes or sham-treated for a similar duration in the absence of any smoke. Consistency of smoke was monitored by cigarette weights, total particulate matter, concentrations of carbon monoxide (CO), and tetrahydrocannibinol (THC) in smoke, carboxyhemoglobin levels, and plasma THC levels. Except for a transient decrease in dam respiration rates, other gross toxic signs were absent. Reproductive parameters of mothers were generally normal except for a dose-related embryotoxicity predominantly associated with early resorptions. Despite twice the number of embryo/fetal deaths, there were no marihuana soft tissue or skeletal defects. A correlation between dam demises and CO levels among placebo-exposed animals was related to greater quantities of CO being generated during placebo combustion. It has been shown in the rabbit that marihuana is embryotoxic and not a teratogen at plasma THC levels found in human females.
Animals↗
Evaluation of teratogenic potential of N-formylpiperidine in rats.
The teratogenic potential of a versatile solvent, N-formylpiperidine (NFP), was evaluated in the rat. Three groups of 25 mated female Sprague-Dawley rats were given 110, 220, or 440 mg/kg/day NFP in distilled water by gavage on Days 6 through 20 of gestation. A control group of 25 animals received distilled water on a comparable regimen. Maternal animals were observed daily for signs of toxicity; body weights and food consumption were measured at regular intervals throughout the study. All animals were euthanized on Gestation Day 21 and the fetuses examined for cleft palate and external abnormalities. One-half of the fetuses in each litter were examined for visceral anomalies while the remaining fetuses were examined for skeletal malformations after appropriate staining. One female in the high dosage group died on Gestation Day 12. Clinical signs of toxicity, observed in 6 females in the high dosage group, included tremors, convulsive movements, and an apparent weakness of the legs. Maternal toxicity, in terms of significantly decreased body weight and food consumption, was observed in the mid and high dosage groups. Food consumption was also significantly depressed for the first 4 days of dosing in the low dosage group. There was a significant increase in number of resorptions in the high dosage group when compared to controls. No effects were observed on other reproductive parameters. Mean fetal body weight was significantly lower in the high dosage group when compared to controls. While the incidence of fetal malformations on a litter basis was higher in the high dosage group, this change was not statistically significant.(ABSTRACT TRUNCATED AT 250 WORDS)
Animals↗
Strain-dependency of procarbazine-induced testicular toxicity.
Three strains of rat were used to examine strain-dependency of procarbazine-induced testicular toxicity. CCFHB and CCFY1 outbred albino rats and inbred PVG piebald variegated rats were treated weekly with procarbazine (200 mg/kg/dose x 4). Fifty-six days later, the rats were killed and reproductive parameters evaluated. Strain-related differences in body, testis, prostate, seminal vesicle weights, testis sperm, intratesticular testosterone, and [125I]hCG binding to testicular LH receptors were observed. Although treatment with procarbazine affected testis function in all strains, significant interactions occurred between treatment and strain. LH receptor binding and stem-cell survival were more severely affected in the inbred strain than in outbred strains. Serum testosterone increased in the outbred strain but decreased in the inbred strain, generating an interaction that obscured possible main effects. Significant strain-related differences in within-group variances demonstrated that measurements were more variable in the outbred strains than in the inbred strain. Testes of the inbred strain appeared to be more sensitive to the effects of procarbazine than those of the outbred strains. These data illustrate two important toxicologic phenomena: differences in response variability and differences in target-organ sensitivity, both of which were explained by genetic variability.
Animals↗
Drinking water source and reproductive outcomes in Sprague-Dawley rats.
As part of our work on the influence of water source on reproductive outcome, Sprague-Dawley rats were randomized to tap water, bottled water, or deionized water treatment groups, utilizing 160 animals per treatment; animals received the water prior to and during pregnancy. Rats were shipped in four batches (A-D). Batch effects were seen for several reproductive parameters. Because the tap water supply was interrupted by an earthquake resulting in an unbalanced design, primary analyses utilized only batches C and D, which included most of the tap water-treated rats. A treatment effect with respect to resorption frequency was seen that was marginally significant using a fixed-effects analysis of variance (P = 0.053), but not when batch was entered as a random effect (P = 0.36). The data were modeled by logistic regression, controlling for batch, litter size, and batch-treatment interaction. The odds ratio comparing tap to bottled water was 1.8 (95% CI 1.0 to 3.3, P = 0.05), which was similar to the epidemiologic result that prompted this study. The magnitude of this association varied by batch, and the difference in resorption frequency was within the range of variation seen for control animals. Although these findings do not justify public health action at this time, further investigation is warranted.
Animals↗
Comet assay analysis of multigenerational genomic instability (F0-F2) in Aedes aegypti exposed to gamma radiation in Sterile Insect Technique.
The use of irradiation in the Sterile Insect Technique (SIT) is a sustainable and environmentally friendly strategy for controlling Aedes aegypti populations by the release of sterile males. However, the potential toxic effects of radiation on mosquito genetic material, as well as the heritability of such damage, remain insufficiently understood. In this study, we evaluated gamma radiation-induced DNA damage (20, 30, 40, and 50 Gy) in male pupae (F0 generation) and assessed the persistence of these effects in subsequent generations (F1 and F2) using the comet assay in hemocytes. In the parental generation, a significant dose-response relationship was observed, with increasing radiation doses associated with higher damage index and damage frequency (p < 0.05). In the F1 generation, both larvae and adults exhibited significantly greater DNA damage than the control group, particularly at doses of 30 and 40 Gy, supporting the inheritance of radiation-induced genomic instability. In the F2 generation, genotoxic effects were attenuated, although residual damage remained detectable in adults, suggesting partial recovery of genomic stability, possibly influenced by DNA repair mechanisms and/or selective pressures. No viable offspring were obtained at 50 Gy, confirming the sterilizing efficacy of higher doses. Integration of comet assay results with micronucleus data and reproductive parameters reinforces the association between DNA damage, mutagenic effects, and reduced fertility. These findings indicate that radiation-induced genotoxic effects may persist beyond the irradiated generation but tend to decline across generations. Overall, this study provides insights into the balance between achieving sterility and preserving biological quality in SIT programs, contributing to optimizing radiation doses and enhancing the safety and efficacy of vector control strategies.
Comet assay↗
Reproductive responses in ewes treated with eCG or increasing doses of royal jelly.
This experiment was conducted to evaluate the effect of administering increasing doses of royal jelly (RJ) on reproductive parameters in ewes. Additionally, this study compared using RJ vs. equine chorionic gonadotropin (eCG) in estrous cycle control. In May (transitional period between anestrous and the breeding season) 37 multiparous, winter-lambing Awassi ewes 3-6 years of age (average body weight of 53+/-1.2 kg) were fitted with intravaginal flourogestone acetate-impregnated sponges (FGA, 40 mg) for 12 days. Ewes were randomly assigned into five treatment groups to receive no RJ (CON, n=7), 250 mg RJ/d (RJ250, n=8), 500 mg RJ/d (RJ500, n=8), 750 mg RJ/d (RJ750, n=7), or 600IU eCG (eCG, n=7). Royal jelly was administrated orally on daily basis when sponges were in place while eCG was administered on the day of sponge withdrawal (d 0). Behavioral estrus was checked using fertile Awassi rams at 6h intervals for 5 days beginning on d 1. Interval from d 0 to onset of estrus was shorter (P<0.05) in eCG than in CON and RJ250 groups. No differences in the onset of estrus were detected among the RJ-treated groups. The intervals from d 0 to first progesterone rise were shorter (P<0.05) in the eCG-treated compared with RJ-treated and control ewes (100+/-15.3, 138.4+/-14, 135.7+/-15, 155.6+/-15, 154.4+/-15.1h in eCG, CON, RJ250, RJ500, and RJ750, groups, respectively). The overall pregnancy rate from mating at induced estrus was 75.7% (28/37). Of these ewes, 23/37 (64.8%) lambed within 155 days following d 0. Lambing rate was higher (P<0.05) in the RJ500 group compared with controls. Lambing rate from mating at induced estrus was 2/7 (28.5%), 4/8 (50%), 8/8 (100%), 4/7 (57%), and 5/7 (71%) in CON, RJ250, RJ500, RJ750, and eCG groups, respectively. Results of the present study demonstrate that eCG but not RJ was effective in improving estrus expression in ewes during the transition between the non-breeding and breeding seasons. Royal jelly may be effective in improving pregnancy and lambing rates but further studies are required to confirm such findings.
Animals↗
The minipig in toxicology.
The use of pigs (Sus scrofa) in biomedical research is well established in particular in surgical and physiological research. For years both pigs and minipigs have been used in pharmacology and toxicology to answer specific questions when the more conventional species have been found unsuitable. The development of minipigs has resulted in strains of more manageable size than the domestic pig. Because of their well-accepted physiological and other similarities to humans, minipigs are becoming increasingly attractive toxicological and pharmacological models. There are several strains of minipigs (Göttingen, Yucatan, Sinclair, Hanford and other). This presentation is based on experience primarily with the Göttingen minipigs. In toxicology in Europe minipigs have become very popular for pharmaceutical studies in place of dogs and primates. Minipigs have been shown to be sensitive to a wide variety of drugs and chemicals. It has become obvious that minipigs can be used for all routes of administration, and in many cases are preferable to dogs or primates for metabolic or pharmacological reasons. There are advantages over the traditional non-rodent species in relation to specific responses to particular drug classes. Their use in general toxicology testing employing the continuous intravenous infusion, dermal or inhalation route has been described in detail in the literature. Background data on toxicological endpoints (ophthalmology, clinical pathology, ECG, organ weight, histopathology and reproduction parameters) have been well-established allowing studies to be interpreted. In the context of this conference, histopathology and toxicopathology data of spontaneous or drug-induced origin are available in the scientific literature. Now there is good supply of high-quality minipigs of known disease status. There are advantages over the traditional non-rodent species in relation to the ethical difficulties of use of animals in biomedical research. Consequently, there are scientific, economic and sociological reasons that make minipigs good toxicological and pharmacological models. The principal disadvantage is that toxicity testing in minipigs may require more test compound than the traditional species.
Animals↗
Dose-response effects of Lepidium meyenii (Maca) aqueous extract on testicular function and weight of different organs in adult rats.
Lepidium meyenii (Brassicaceae) known as Maca grows exclusively between 4000 and 4500 m over the sea level in the Peruvian central Andes. The dried hypocotyls of Maca are traditionally used as food and for its supposed fertility-enhancing properties. A dose-response study was performed to determine the effect of 7 days oral administration of an aqueous lyophilized extract of Maca at 0.01-5 g/kg (corresponding to 0.022-11 g dry hypocotyls of Maca/kg) on body and different organ weights, stages of the seminiferous tubules, epididymal sperm count and motility, and serum testosterone and estradiol levels in rats. In doses up to 5 g extract/kg, no toxicity was observed. Almost all organ weights were similar in controls and in the Maca extract-treated groups. Seminal vesicles weight was significantly reduced at 0.01 and 0.10 g extract/kg. Maca increased in length of stages VII-VIII of the seminiferous tubules in a dose-response fashion, with highest response at 1.0 g/kg, while caput/corpus epididymal sperm count increased at the 1.0 g dose. Cauda epididymal sperm count, sperm motility, and serum estradiol level were not affected at any of the doses studied. Serum testosterone was lower at 0.10 g extract/kg. Low-seminal vesicle weights correlated with low-serum testosterone levels (R2=0.33; P<0.0001) and low-testosterone/estradiol ratio (R2=0.35; P<0.0001). Increase in epididymal sperm count was related to lengths of stages VII-VIII. Highest effect on stages VII-VIII of the seminiferous tubules was observed at 1.0 g Maca aqueous extract/kg. The present study demonstrated that Maca extract in doses up to 5 g/kg (equivalent to the intake of 770 g hypocotyls in a man of 70 kg) was safe and that higher effect on reproductive parameters was elicited with a dose of 1 g extract/kg corresponding to 2.2 g dry Maca hypocotyls/kg.
Administration, Oral↗
Transgenic mice expressing F3/contactin from the transient axonal glycoprotein promoter undergo developmentally regulated deficits of the cerebellar function.
We have shown that transgenic transient axonal glycoprotein (TAG)/F3 mice, in which the mouse axonal glycoprotein F3/contactin was misexpressed from a regulatory region of the gene encoding the transient axonal glycoprotein TAG-1, exhibit a transient disruption of cerebellar granule and Purkinje cell development [Development 130 (2003) 29]. In the present study we explore the neurobehavioural consequences of this mutation. We report on assays of reproductive parameters (gestation length, litter size and offspring viability) and on somatic and neurobehavioural end-points (sensorimotor development, homing performance, motor activity, motor coordination and motor learning). Compared with wild-type littermates, TAG/F3 mice display delayed sensorimotor development, reduced exploratory activity and impaired motor activity, motor coordination and motor learning. The latter parameters, in particular, were affected also in adult mice, despite the apparent recovery of cerebellar morphology, suggesting that subtle changes of neuronal circuitry persist in these animals after development is complete. These behavioural deficits indicate that the finely coordinated expression of immunoglobulin-like cell adhesion molecules such as TAG-1 and F3/contactin is of key relevance to the functional, as well as morphological maturation of the cerebellum.
Animals↗
Chronic morphine exposure during puberty decreases postpartum prolactin secretion in adult female rats.
Opiate use in teenage populations has been increasing in recent years. The potential impact of exposure to high levels of opiates at a time when reproductive systems are maturing has not been well studied, especially in females. The present study used an animal model of adolescent opiate abuse in females to examine the potential impact of high levels of opiates during puberty on several reproductive parameters, including suckling-induced prolactin secretion. Two groups of juvenile female rats were administered increasing doses of morphine sulfate or saline (s.c.) from age 30-50 days, beginning with a dose of 2.5 mg/kg and achieving a maximal dose of 50 mg/kg. As adults, these females were mated and reared either their own or foster pups. On either postpartum day 5 or 10, following a 4 h separation, suckling-induced prolactin secretion was measured. In addition, on postpartum day 5 maternal behavior latencies were determined. The results demonstrate reduced suckling-induced prolactin secretion on postpartum day 5 in females previously exposed to morphine during pubertal development. These effects were observed in females rearing either their own or fostered pups. These effects were not due to any differences in maternal behavior latencies, as retrieval or crouching latencies were unaffected. In summary, chronic morphine exposure during puberty results in changes in the regulation of prolactin secretion during early lactation, which are observed several weeks after cessation of drug treatment. These data suggest that prior opiate use during puberty can continue to affect the regulation of prolactin secretion into adulthood.
Age Factors↗
Season effect on genitalia and epididymal sperm from Iberian red deer, roe deer and Cantabrian chamois.
Seasonality deeply affects the physiology and behavior of many species, and must be taken into account when biological resource banks (BRBs) are established. We have studied the effect of seasonality on many reproductive parameters of free-ranging Iberian red deer, roe deer and Cantabrian chamois, living in Spain. Testicles from hunted animals were collected and sent to our laboratory at different times during the year. We recorded the weight and volume of testis, the weight of the epididymis and its separate parts (caput, corpus, and cauda), the weight of the sperm sample collected from the cauda epididymis, and several sperm parameters (sperm concentration, spermatozoa recovered, motility, HOS test reactivity, acrosomal status, and viability). We studied the data according to several periods, defined accordingly to each species. For red deer, we defined rut (mid-September to mid-October), post-rut (mid-October to mid-December), and non-breeding season (February). For roe deer, they were pre-rut (June), rut (July), post-rut (first fortnight of August), and non-breeding season (September). For chamois: non-breeding season (June to mid-September) and breeding season (October-November). The rut/breeding season yielded significantly higher numbers for almost all parameters. However, in the case of red deer, sperm quality was higher in the post-rut. For roe deer, testicular weight was similar in the pre-rut and in the rut, and sperm quality did not differ significantly between these two periods, although we noticed higher values in the rut. In the case of chamois, sperm quality did not differ significantly from the breeding season, but data distribution suggested that in the non-breeding season there are less males with sperm of good quality. On the whole, we find these results of interest for BRB planning. The best season to collect sperm in this species would be the breeding season. However, post-rut in red deer, pre-rut in roe deer, and non-breeding season in chamois could be used too, because of the acceptable sperm quality, despite the lower quantity salvaged. More in-depth research needs to be carried out on the quality of sperm salvaged at different times of the year in order to confirm these findings.
Acrosome↗
Effects of in utero and lactational exposure to flutamide in SD rats: comparison of the effects of administration periods.
Pregnant CD(SD) IGS rats were given flutamide (FLUT) orally at doses of 0.4, 2, or 10 mg/kg/day from gestational day 6 to postnatal day (PND) 20, and the effects of FLUT exposure on male offspring were examined 10 weeks after birth, and compared to the effects in offspring treated after weaning and in offspring untreated after weaning. Although the body weight of the dams treated with FLUT remained normal, two dams in the 10 mg/kg/day group were killed because of abnormal parturition periods and loss of all the pups. The number of stillborns and dead newborns at birth was significantly higher in the 10 mg/kg/day group than in the control groups. No abnormalities in the reproductive parameters of the other dams treated with FLUT were detected. The body weights of the male offspring in each group remained normal from birth until the end of the study. The ano-genital distance was significantly shortened in 2 and 10 mg/kg/day groups. Changes in the organ weights and gross findings were detected in the 2 and/or 10 mg/kg/day groups with or without the continuous administration of FLUT after weaning; these changes were more appreciable in groups treated with FLUT after weaning than in groups untreated after weaning. The prolongation of preputial separation was observed in the 0.4 and 2 mg/kg/day groups treated with FLUT after weaning, but this change was not detected in the same dose groups untreated after weaning. The testosterone levels were higher in the 10 mg/kg/day group treated with FLUT after weaning. The present data demonstrated that the endocrine-mediated effects on rats were more appreciable in offspring treated with FLUT after weaning than in offspring untreated after weaning.
Abnormalities, Drug-Induced↗
When is a sex difference not a sex difference?
Brain sexual differentiation in mammals requires activity of gonadal hormones; organizational effects of these steroids on brain development occur early in life while activational ones in adulthood ensure appropriate and timely sex-specific behaviors. This traditional view has long served as a reliable model for sexual differentiation of reproductively relevant brain structures. Here, we take a fresh look at this model but refocused in the context of sexual differentiation of non-reproductive parameters and with an emphasis on the hippocampus, a telencephalic brain structure predominantly involved in cognition and stress regulation. We explore sex differences in morphology, neurochemistry, and hippocampal-dependent behaviors to propose a new prototype that can be used to explain and further investigate the effects of steroid hormones, those synthesized gonadally or intracerebrally, on hippocampal development and function. We also propose that a new vernacular be employed, one that distinguishes hormonally modulated responses from sex differences, and argue these are mechanistically and functionally distinct. Understanding when and how the sexes are different is as important as understanding when and how they are the same, at the biological, social, and cultural level.
Animals↗
Teratology study of intravaginally administered nonoxynol-9-containing contraceptive cream in rats.
Pregnant Long-Evans Hooded rats were intravaginally administered nonoxynol-9, a non-ionic surfactant used as a spermicidal agent in Delfen Contraceptive Cream (Ortho Pharmaceutical Corporation, Raritan, N.J.) at dosages of 4 or 40 mg/kg/day (2 and 20 times the clinical usage) on days 6 through 15 of gestation. Untreated, vehicle and sham control groups were also incorporated into the study protocol. No meaningful differences were observed between the treated and control groups in maternal toxicity, gross and microscopic appearance of vagina, maternal reproductive parameters, fetal toxicity, and the incidence of visceral and skeletal malformations.
Animals↗