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PubMed2002

The effects of atrazine metabolites on puberty and thyroid function in the male Wistar rat.

Recently we reported that atrazine (ATR), a chlorotriazine herbicide, alters the onset of puberty in male Wistar rats. In this study, we examined the same reproductive parameters in the developing male rat following a similar exposure to the primary, chlorinated metabolites of atrazine. Intact male Wistar rats were gavaged from postnatal day (PND) 23 through PND 53 and several reproductive endpoints were examined. The doses selected were the molar equivalents to atrazine in our previous work. Deethylatrazine (DEA), deisopropyl-atrazine (DIA), and diaminochlorotriazine (DACT) were administered by gavage at doses equivalent to the atrazine equimolar doses (AED) of 6.25, 12.5, 25, 50, 100, or 200 mg/kg. Preputial separation (PPS) was significantly delayed by DEA at 25, 100, and 200 AED, by DIA at 25, 100, and 200 AED, and by DACT at 12.5 through 200 AED. When the males were killed on PND 53, DEA (100 and 200 AED), DIA (50 through 200 AED), and DACT (200 AED) treatments caused a significant reduction in ventral prostate weight, while only the highest doses of DIA and DEA resulted in a significant decrease in lateral prostate weight. Seminal vesicle weight was reduced by DEA (25, 100, and 200 AED), DIA (100 and 200 AED), and 100 and 200 AED of DACT. Epididymal weights were reduced in the DEA (200 AED), DIA (200 AED), and DACT (100 and 200 AED) treatment groups. Serum testosterone was reduced only in the males receiving the 2 highest doses of DIA. Serum estrone was increased in the 2 highest doses of the DACT group, while serum estradiol was not different in any group. No differences were observed in any of the thyroid measures. In summary, the metabolites of ATR delay puberty in a manner similar to that observed in the previous study testing atrazine. These data also suggest that the 3 chlorinated metabolites are similar to ATR, by affecting the CNS control of the pituitary/gonadal axis and subsequent development of the reproductive tract.

Animals↗

PubMed1988

[Safety of a new anticoccidial agent, clazuril, during reproduction in carrier pigeons].

In a six-month study, the safety of repeated treatments with clazuril, a new anticoccidial agent for the treatment of pigeons, was evaluated during 4 to 5 consecutive reproduction cycles. Clazuril was administered weekly at the recommended therapeutic dose level of 2.5 mg/pigeon and at twice this dose. The results were compared to placebo treatment. Evaluation was based on the following parameters: reproductive behaviour, egg laying, fertilisation, embryonic mortality, hatching, percentage of weaning and time interval between consecutive reproductive cycles. Maternal-paternal toxicity (body weight evolution, feather coat) and tolerance in newborn pigeons (general behaviour, daily gain in body weight, feathering, skeletal anomalies) were also evaluated. In all the treatment groups, reproductive performance was comparable and no drug- or dose-related side-effects were observed. Fertilisation, embryonic mortality and the time-interval between the consecutive reproductive cycles remained within the normal physiological range. Hatched pigeons showed a satisfactory daily weight gain and deaths among these birds were exceptional. Tolerance of clazuril in adult as well as in day-old pigeons was exceptionally good and body weight evolution, feathering and mortality were not adversely affected. No drug-related pathological findings or skeletal anomalies were detected in the animals at autopsy. It can be concluded that repeated treatments with clazuril are entirely harmless for pigeons during reproduction, even at double the therapeutic dose level. Clazuril is well tolerated by newborn and growing pigeons, which means that pigeon house group treatments during reproduction may be performed without any risk.

Acetonitriles↗

PubMed2004

Body weight of mares and foals, estrous cycles and plasma glucose concentration in lactating and non-lactating Lipizzaner mares.

This study summarizes weight development, plasma glucose concentrations and reproductive parameters in lactating (n = 46) and non-lactating Lipizzaner mares (n = 11) throughout the breeding season. It was the aim of the study to analyse if an energy deficit with possible effects on reproductive functions occurs at any time during the first 4 months of gestation. Mean gestation length was 334.3 +/- 7.3 days. Gestation of foals born in May/June was shorter (P < 0.01) than for foals born in March/April. Out of the 46 lactating mares, 44 ovulated between Days 8 and 18 postpartum and two mares ovulated on days 30 and 145, respectively. Pregnant mares were significantly (P < 0.001) heavier (600.1 +/- 5.3 kg) than non-pregnant mares (521.8 +/- 10.0 kg) at the beginning of the study. Birth resulted in weight reduction of 64.8 +/- 2.4 kg. During the first 2 weeks postpartum mares lost on average 3.0 +/- 1.8 kg and in the following 2 weeks gained 3.6 +/- 1.4 kg of weight. Thereafter, weight increased slightly but continuously (P < 0.01). At no time after foaling, weight differed significantly between groups. Weight of the foals three days after birth varied between 29 and 67 kg (53.7 +/- 1.1 kg). Average daily weight gain of foals was relatively constant throughout the study period (1.15 +/- 0.17 kg). Although lactation at no time was associated with a major weight loss, it had clear effects on energy metabolism as shown by constantly lower plasma glucose concentrations in lactating mares. Glucose concentrations decreased after foaling and were significantly lower in lactating mares from Weeks 3 to 16 after foaling than at corresponding times in non-lactating mares (P < 0.01). However, glucose concentrations were still within the physiological range. Mares seem to be able to compensate energy losses during lactation mainly by increasing feed intake and not by mobilisation of body fat.

Aging↗

PubMed2000

Effects of gossypol on sperm viability and plasma sex steroid hormones in male sea lamprey, Petromyzon marinus.

Male sea lampreys Petromyzon marinus were injected with different doses of gossypol acetic acid in an attempt to sterilize them for use in a program for controlling the sea lampreys through the release of sterile males. Two lots of sea lamprey were used in these experiments. The first lot was divided into three groups and fish were injected intraperitoneally (i.p.) with 0.2 ml 50% ethanol as a control group or with gossypol suspended in ethanol at 100 and 200 mg/kg. The second lot was also divided into three groups and fish were either injected i.p. with vehicle as controls or gossypol at 25 and 50 mg/kg. Sperm weight, concentrations and motility were recorded after 31, 36 and 40 days or 24, 28 and 33 days in lots 1 and 2, respectively. Blood was collected from the caudal vessel prior to injections with gossypol and after 40 or 33 days in lots 1 and 2, respectively. Plasma levels of estradiol-17beta (E2), testosterone (T), progesterone (P) and 17,20beta-dihydroxy-4-pregnen-3-one (17,20betaP) were measured by radioimmunoassay. At the end of the experiment, the testis were removed and fixed in Bouin's solution for histological examination. High mortality was observed at the day of injection in the group treated with 200 mg/kg (84.6%), 100 mg/kg (41.7%), and 50 mg/kg (25%). Sperm concentrations were higher in control fish in comparison to most of the treated groups during the first sperm sampling (day 31 or 24), but then differences disappeared. At each sampling, sperm motility was higher in control groups than in treated groups and significant differences were observed (e.g. between control and 50 mg gossypol/kg). Fertility, evaluated at optimized sperm/egg ratio (5 x 10(4) sperm/egg) did not differ among treatments and controls. Changes in mean plasma sex steroid levels in the various treated groups were not significant, but a trend of decreasing plasma E2 was observed with increasing dose of gossypol. The structure of the testis was examined at the end of the experiment using light microscopy and appeared to be unchanged in gossypol-treated lampreys as compared to that of control animals. These findings suggest that gossypol injection into lamprey interferes with some of the reproductive parameters. Although high mortality rate precludes a single i.p. injection of gossypol as a favorable mode of chemosterilization in the lamprey, it would be useful to reassess the means of transfer of gossypol to reproductive tissues. This notion is further supported by the results of an in vitro sperm toxicity assay which revealed that gossypol, at a dose of 100 microM, has an antifertility action in this species.

Animals↗

PubMed1995

Carisoprodol: reproductive assessment by continuous breeding in Swiss mice.

Carisoprodol (CARI), a commonly prescribed neuromuscular relaxant, was evaluated for reproductive toxicity in Swiss CD-1 mice using the Reproductive Assessment by Continuous Breeding (RACB) protocol. Male and female mice were given CARI in corn oil suspension by daily gavage at doses of 0, 300, 750, and 1200 mg/kg body wt/day. Clinical signs of general toxicity in F0 animals included sedation, primarily in the high-dose group during the first week of exposure, and reduced body weight in high-dose females. CARI administration for 14 weeks did not affect the ability of the F0 animals to produce litters. However, decreases in proportion of pups born alive (4%) and absolute (5%) and adjusted live pup weight (7%) were observed at 1200 mg/kg CARI when compared to controls. In a crossover mating trial to determine the affected sex, there were no significant differences in the measured reproductive parameters. CARI at the high dose increased the proportion of time spent in proestrus and estrus, but cycle length was unaffected. At F0 necropsy (Week 27 of treatment), all sperm parameters were normal. Right epididymis and liver weights, relative to body weight, were increased (12 and 23%, respectively) over the control group for high-dose males. A mating trial to determine the fertility and reproductive competence of the F1 generation showed no effect of CARI on indices of mating, pregnancy, or fertility, the proportion of F2 pups born alive, the sex ratio of live F2 pups, live F2 pup weight, or gestation length.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

PubMed2003

Reproductive seasonality of the male Florida gar, Lepisosteus platyrhincus.

The objective of this study was to characterize the reproductive seasonality of a wild population of male Florida gar, Lepisosteus platyrhincus. We measured the gonadosomatic index, reproductive stage of the testes, seminiferous tubule area, and plasma concentrations of testosterone and 11-ketotestosterone for each fish. A seasonal pattern was observed in the reproduction of male gar. Following a quiescent period in the summer, there was an increase in plasma testosterone concentration during the fall, which was associated with the onset of active spermatogenesis as indicated by an increase in seminiferous tubule area and gonadosomatic index. Plasma concentrations of 11-ketotestosterone remained basal during the summer and winter and then increased during the early spring. These data, taken together with data from female gar collected in a parallel study by our lab, suggest that spawning occurred during the early spring (February-March), followed by a general decrease in reproductive parameters to summer levels. Recognizing that peaks of hormone concentrations and spawning period could vary with annual seasonal variation, this study is important because it is the first characterization of the seasonal morphological and endocrinological reproductive pattern in a holostean species. Furthermore, it increases our understanding of the reproductive biology of semitropical fishes.

Animals↗

PubMed1992

[Reproductive and developmental toxicity study of suplatast tosilate (IPD-1151T) (4)--Perinatal and postnatal study in rats by oral administration].

In order to assess the effect of suplatast tosilate (IPD-1151T) on pregnancy of the rat, and the post natal development to maturity of the F1 generation, daily doses of 0 (control), 200, 600 and 1800 mg/kg/day were administered orally to female Wistar rats from day 17 of pregnancy to day 21 after delivery. All females were allowed to give birth and rear their young to weaning. F0 dams showed no treatment-related changes in general conditions including the state of delivery or nursing, gestation period, birth rate, or autopsy findings. The dams at 1800 mg/kg/day showed a tendency to reduction in body weight gain and a decrease in food consumption. F1 offspring showed no treatment-related changes in clinical signs on the birth day or during the nursing period, external examination on the birth day, general condition, physical or reflex development, open-field test, water multiple T-maze test, autopsy findings, organ weights, skeletal examination, reproductive ability, or histopathological examination on the reproductive organs of the animals of both sexes that failed to produce pregnancy. The offspring at 1800 mg/kg/day showed a reduction or its tendency in body weight gain. There were no treatment-related changes in any of reproductive parameters of F1 dams including external examination of F2 fetuses. The results suggest that the non-effective dose level of IPD-1151T is 600 and 1800 mg/kg/day for F0 dams in general toxicity and reproductive ability, respectively, and 600 mg/kg/day for F1 offspring in post natal development under the conditions of this study.

Abnormalities, Drug-Induced↗

PubMed1984

[Effect of movement on feed digestibility and reproduction in pregnant dry cows].

Two experiments were carried out--in October and November and in May and June--with two groups of cows of 25 each, belonging to the Black-and-white breed. Up to the time of the tests and during the experimental period itself both groups of animals were given a ration that was one and the same in terms of composition and size. However, the test group was subjected to a regular daily walk of 3 km on a proper field terrain. It was established that regular movement produced a favourable effect on the health condition, digestibility, parturition, and puerperal affections as well as on the milk capacity and reproduction parameters. The health status and development of offsprings was also favourably affected.

Animal Feed↗

PubMedDate not supplied

Detection limits of different approaches in behavioral teratology, and correlation of effects with neurochemical parameters.

Five laboratories collaborated in the evaluation of detection limits of different testing concepts in behavioral teratology. In one laboratory, rat dams were treated by gavage with five doses of methylmercury (0.0, 0.25, 0.05, 0.5, and 5.0 mg/kg/day). The treatment period was restricted to days 6 to 9 of gestation. The usual reproduction parameters were assessed in the dams. The offspring (88-99 per group) were subjected to a routine developmental and behavioral testing battery. After completion of these tests, random samples of the animals were further investigated in four other laboratories using the following techniques: auditory startle habituation, visual discrimination and figure-8 activity monitor; wheel-shaped activity monitor and spatial alternation operant conditioning; two-compartment locomotor activity, passive avoidance and male ultrasonic vocalization during sexual behavior; assays of the weight of different brain areas, their glial fibrillary acidic (GFA) protein and S-100 protein concentration. The following dose-dependent effects were noted in ascending dose sensitivity order: delayed vaginal opening; increased and more variable passiveness in spatial alternation; impaired swimming behavior, increased GFA protein concentration in the cerebellar vermis; increased auditory startle amplitude, decreased intertrial interval pokes in the visual discrimination test, increased percentage of visits in passive area of figure-8 activity monitor, increased path iteration frequencies and decreased local activity in the wheel-shaped activity monitor, decreased locomotor activity in the two-compartment monitor, increased cerebellar vermis weight, and decreased S-100 protein in the hippocampus. Therefore, this study showed comparable sensitivities for the behavioral testing battery, for some automated multiparametric test systems and for the neurochemical assays.

Animals↗

PubMedDate not supplied

Overview of male reproductive pathology.

An understanding of form and function is important for examination of the male reproductive tract. A basic understanding of spermatogenesis and hormonal function in the reproductive tract is essential for the pathologists in this evaluation. Gross and histologic reproductive changes need to be distinguished from normal variation and correlated with the reproductive status of the animal. This is especially important when correlating histologic changes with organ weight and other reproductive parameters, such as seminal analysis data. Sexual maturity of animals and tissue handing can impact interpretation. Sexual immaturity of preclinical safety animals can present challenges for accurate identification of compound-related changes. Likewise, proper handling of unfixed reproductive tissues and appropriate selection of a fixation protocol are important in avoiding artifacts that may interfere with the microscopic evaluation. The histopathology technician needs to recognize testicular landmarks that allow for correct orientation at trimming so the pathologist can assess not only the morphology of seminiferous tubules but also the outflow tract. For the most effective evaluation of the male reproductive tract, the testes and epididymides should be examined concurrently. Although the term "staging" is often used inappropriately, the pathologist should review testicular tissues in a "stage-aware" manner. This article reviews gross and histologic changes of the male reproductive tract as well as tissue orientation and fixation to assist in accurate interpretation of potential treatment-related changes in male reproduction.

Animals↗

PubMed2003

Absence of reproductive and developmental toxicity in rats following oral dosing with nelfinavir.

The potential for nelfinavir mesylate (VIRACEPT) to produce reproductive toxicity was evaluated in rats administered oral doses of 200, 500, or 1000mg/kg/day. In the fertility and early embryonic development to implantation study, male rats were treated beginning 28 days prior to mating until necropsy and females for 2 weeks prior to mating and through gestation day (GD) 7. In the pre- and postnatal development study, pregnant rats were treated from GD 6 through lactation day (LD) 20. Selected F(1) pups from this study were evaluated in sensory and behavioral tests and were subsequently mated. Pregnant F(1) females were euthanized on GD 20 and their F(2) fetuses were examined. F(1) animals were not directly dosed with the drug. No treatment-related effects were observed on any male reproductive parameters. Administration of nelfinavir did not produce adverse effects on fertility, pregnancy, embryo-fetal development, parturition, or lactation in the F(0) generation. Similarly, no adverse effects of nelfinavir treatment were observed on pre- and postnatal growth, development, reproductive performance and embryo-fetal development in the F(1) offspring. Based on the results of this study, the no-observed-adverse-effect-level (NOAEL) for developmental and reproductive toxicity in rats was considered to be 1000mg/kg/day, the highest dose tested.

Administration, Oral↗

PubMed2006

Three-generation evaluation of dietary para-nonylphenol in CD (Sprague-Dawley) rats.

This study evaluated the potential for dietary para-nonylphenol (NP; CAS No. 84852-15-3) to affect parental fertility and growth and development of three offspring generations in CD (Sprague-Dawley [SD]) rats, including sperm counts across generations to determine the validity of equivocal reductions observed in the F2 generation by R. E. Chapin et al. (1999, Toxicol. Sci. 52, 80-91). Male rat kidney toxicity was also examined based on inconsistent observations in NP-exposed rats at 2000 ppm but not at 200 or 650 ppm in Purina 5002 (H. C. Cunny et al., 1997, Regul. Toxicol. Pharmacol. 26, 172-178) and at all of these NP concentrations in NIH-07 diet (R. E. Chapin et al., 1999, Toxicol. Sci. 52, 80-91). Concentrations were 0, 20, 200, 650, and 2000 ppm NP in Purina 5002 diet and 0 and 650 ppm NP in NIH-07 diet. 17beta-estradiol (E2) was used as a positive control at 2.5 ppm in Purina 5002 diet. There were no NP effects on any reproductive parameters in any generation, including sperm counts. Kidney toxicity (histopathology) occurred at 650 and 2000 ppm with no clear difference for the two diets. Ovarian weight was decreased at 2000 ppm NP in all generations, with no effect on reproduction. Dietary E2 at 2.5 ppm caused renal, reproductive, and developmental (lactational and peripubertal) toxicity in all generations. This study confirmed that dietary NP is not a selective reproductive toxicant with an no observable adverse effect level (NOAEL) of > 2000 ppm ( approximately > 150 mg/kg/day) and provided an NOAEL for male rat kidney toxicity of 200 ppm NP (approximately 15 mg/kg/day).

Animals↗

PubMed2001

Neither vegetative nor reproductive advantages account for high frequency of male-steriles in southern Spanish gynodioecious Daphne laureola (Thymelaeaceae).

In gynodioecious species, male-steriles (termed "females" hereafter) usually exhibit some reproductive advantage over hermaphrodites that allow them to compensate for the loss of male reproductive function. This compensation can result from higher fecundity, vegetative outperformance, and/or lower inbreeding depression. In this study we compared vegetative and reproductive parameters of female and hermaphrodite Daphne laureola individuals in two southeastern Spanish populations and estimated the magnitude of inbreeding depression up to the seedling emergence stage by conducting controlled pollinations and experimental sowings of seed progenies in the field. Reproductive shrubs of both sexes did not differ significantly in size, leaf production, leaf size, leaf growth, nutrient allocation to leaves, and production of flowers and fruits. Seed set and seed size of cross- and self-pollinated flowers of hermaphrodites and cross-pollinated females were also similar. Seedling emergence rates of self- and cross-pollinated seeds from hermaphrodites under natural field conditions were similar, suggesting a minor role of inbreeding depression up to that reproductive stage. Seeds from females produced more seedlings than selfed seeds from hermaphrodites. In 21 populations surveyed in the study region over a broad geographical and elevational gradient, the proportion of females ranged between 20.6 and 56.1% and was inversely related to elevation. The establishment and maintenance of females in southeastern Spanish populations of D. laureola seem to be mainly mediated by ecological factors.

Journal Article↗

PubMed1991

Effects of ivermectin (MK-933) on the reproductive rate of Aedes aegypti (Diptera: Culicidae).

Aedes aegypti (L.) females were blood fed a single time on rabbits previously injected subcutaneously with ivermectin at 10 or 50 times the labeled dose recommended for cattle (0.2 mg [AI]/kg body weight). Although adult mosquito survival was unchanged by the low dose, fecundity and hatch were depressed slightly. Females fed on rabbits at the high dose exhibited reduced survival and egg production compared with females fed on control rabbits. Eggs from these females also were less likely to hatch, and subsequent larval survival was lower than controls. The effect of ivermectin on these reproductive parameters diminished as the time between drug administration and blood meal increased.

Aedes↗

PubMed2026

Effect of Roux-en-Y Gastric Bypass and Sleeve Gastrectomy on Male Sexual Function: A Systematic Review and Meta-Analysis.

BACKGROUND: Obesity negatively impacts male sexual function and fertility through hormonal imbalances, endothelial dysfunction, and psychosocial factors. Metabolic and bariatric surgery (MBS) constitutes an effective intervention; however, procedure-stratified changes in male reproductive parameters after Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) remain incompletely synthesized. METHODOLOGY: A systematic search of PubMed, Embase, Cochrane Library, Scopus, and Web of Science was conducted in November 2024. Sexual function, testosterone levels, and semen quality were included. Risk of bias was assessed using MINORS criteria. Random-effects meta-analyses were performed separately for each surgical modality, with heterogeneity quantified via I2 statistics. RESULTS: Twenty-one studies comprising 848 patients were included. Meta-analysis of pre-post data demonstrated that both RYGB and SG were independently associated with improvements in sex hormone-binding globulin and testosterone levels. In studies examining SG, significant improvements were observed in erectile function (SMD: 1.38, 95% CI: 0.66-2.10, p = 0.0002) and sperm concentration (SMD: 0.91, 95% CI: 0.56-1.26, p < 0.00001). Studies evaluating RYGB did not demonstrate statistically significant changes in erectile function (SMD: 0.62, 95% CI: -0.06 to 1.30, p = 0.07) or sperm concentration (SMD: -0.01, 95% CI: -0.45 to 0.42, p = 0.95). CONCLUSION: The meta-analytical findings suggest beneficial effects of both RYGB and SG on male hormonal parameters. Studies of SG demonstrated significant improvements in erectile function and sperm concentration. However, direct comparative analyses between the two procedures were not performed, precluding definitive conclusions regarding their relative efficacy. Future research necessitates head-to-head comparisons with standardized reproductive endpoints and extended follow-up periods.

Humans↗

PubMed1987

Pinealectomy or superior cervical ganglionectomy do not alter reproduction in the wolf (Canis lupus).

Twelve wolves (6 male and 6 female) were used to study the role of the pineal in photoperiodic mediation of seasonal reproduction. Eight wolves were pinealectomized (PNX) or sham-pinealectomized (S-PNX) at 5 mo of age, and 4 were superior cervical ganglionectomized (SCGX) at 16 mo of age (2 males and 2 females per treatment). All attained puberty at the species-typical time, during their second breeding season, except 2 SCGX males that did not survive. Reproductive cycles of an additional male that was SCGX as an adult and the PNX and S-PNX wolves, followed for a minimum of 3 yr, did not differ from each other or from those of unoperated colony wolves on measures of serum testosterone and luteinizing hormone for males, or of serum estradiol and progesterone for females. Nor was the range of dates for ovulation different for treated vs. untreated females. Surgical transection of the olfactory tracts of 1 male and 1 female PNX wolf, inducing anosmia to control for the possibility of pheromonally synchronized cycles, also failed to alter the seasonality of these reproductive parameters. These results do not conform to the model of pineal mediation of sexual cycles for photoperiod-sensitive species. In spite of evidence for photoperiod influence, the wolf apparently relies on a system other than the pineal for seasonal control of reproduction.

Animals↗

PubMed1999

Two-generation reproduction study with para-tert-octylphenol in rats.

Octylphenol (OP) is a commercial intermediate used primarily for the production of octylphenol polyethoxylate surfactants. To determine potential reproductive toxicity of OP, a two-generation reproduction study was conducted according to U.S. EPA OPPTS Guideline 870.3800 (draft 1996). Additional measurements were made on retained F2 offspring. OP was administered ad libitum to five groups of rats (30/sex) at dietary concentrations of 0, 0.2, 20, 200, or 2000 ppm. The 0.2 ppm concentration was included to evaluate potential low dose effects. Effects were observed only at 2000 ppm, including decreased body weights in adults and during the latter portion of lactation in offspring and minor body weight-related delays in acquisition of vaginal opening and preputial separation. No effects on reproductive parameters, testes, prostate, or ovary weights or morphology, on sperm counts, motility, morphology, production, or on estrous cyclicity were observed. No estrogen-like effects were evident. The NOAELs for systemic and postnatal toxicity were 200 ppm and at or above 2000 ppm for reproductive toxicity. This study supports the increasing evidence that screening assays for estrogenic activity or studies with limited numbers of animals and/or unrealistic dose regimens are inappropriate for use in the assessment of human health and environmental risk. It does not support previous preliminary data on low dose effects of OP.

Administration, Oral↗

PubMed2006

A two generation reproductive toxicity study with curcumin, turmeric yellow, in Wistar rats.

The reproductive toxicity of curcumin, turmeric yellow, in Wistar rats was studied in order to generate additional relevant toxicity information for the use of curcumin in humans by oral administration. The two generation reproduction study was designed and conducted in accordance with OECD Guideline No. 416 [OECD, 1983. Guidelines for Testing of Chemicals, Guideline No. 416. Two Generation Reproduction Toxicity Study, adopted on 26th May 1983] and in compliance with Good Laboratory Practices (OECD, 1997 Principles of Good Laboratory Practice for the Testing of Chemicals. OECD, C(97)186/Final). The curcumin, mixed in the experimental diet at the concentrations of 1500, 3000 and 10,000 ppm was fed to three groups of rats, i.e., low, mid and high dose groups, and studied for two successive generations. A concurrent control group received experimental diet without the curcumin mixture. There were no treatment related adverse toxicological effects in the parental animals. No gross or microscopic changes were observed in any of the organs. None of the reproductive parameters were affected and there were no effects on the offspring other than a small reduction in pre-weaning body weight gain of the F2 pups at the highest dose level. It was concluded that the no observed adverse effect level (NOAEL) for reproductive toxicity of curcumin, fed in the diet for two successive generations to rats in this study was 10,000 ppm, which is equivalent to 847 and 959 mg/kg bodyweight (bw) per day for male rats and 1043 and 1076 for females for F0 and F1 generations, respectively. This study was the final toxicology study on curcumin reviewed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) at the 61st Meeting, 2003. The JECFA group considered that the small body weight reduction in the F2 pups of the highest dose group prevented this from being regarded as a no adverse effect level, and so allocated an ADI for curcumin of 0-3 mg/kg bw based on the intake of 250-320 mg/kg bw in the mid-dose group as the NOEL.

Animals↗