-
National Toxicology Program Technical... Nov 1996Phenolphthalein is used as a laboratory reagent and acid-base indicator and in over-the-counter laxative preparations. The National Cancer Institute nominated...
Phenolphthalein is used as a laboratory reagent and acid-base indicator and in over-the-counter laxative preparations. The National Cancer Institute nominated phenolphthalein for study because of its widespread use as a component in numerous laxative preparations and the lack of adequate testing for carcinogenicity in experimental animals. Male and female F344/N rats and B6C3F1 mice were exposed to phenolphthalein (98% to 99% pure) in feed for 14 days, 13 weeks, or 2 years. Genetic toxicology studies were conducted in Salmonella typhimurium, cultured Chinese hamster ovary cells, and mouse peripheral blood. 14-DAY STUDY IN RATS: Groups of five male and five female F344/N rats were given 0, 6,250, 12,500, 25,000, 50,000, or 100,000 ppm phenolphthalein in feed for 14 days. All rats survived to the end of the study. The final mean body weights of all exposed groups of rats were similar to those of the controls. No chemical-related gross or microscopic lesions were observed. 14-DAY STUDY IN MICE: Groups of five male and five female B6C3F1 mice were given 0, 6,250, 12,500, 25,000, 50,000, or 100,000 ppm phenolphthalein in feed for 14 days. All mice survived to the end of the study. The final mean body weights of all exposed groups of mice were similar to those of the controls. No chemical-related gross or microscopic lesions were observed. 13-WEEK STUDY IN RATS: Groups of 10 male and 9 or 10 female F344/N rats were given 0, 3,000, 6,000, 12,000, 25,000, or 50,000 ppm phenolphthalein (equivalent to average daily doses of approximately 200, 400, 800, 1,600, or 3,500 mg phenolphthalein/kg body weight to males and 200, 400, 800, 1,700, or 3,600 mg/kg to females) in feed for 13 weeks. Additional groups of 10 male and 10 female rats designated for clinical pathology evaluations were also given 0, 3,000, 6,000, 12,000, 25,000, or 50,000 ppm phenolphthalein in feed until day 21. All core study rats survived to the end of the study. The final mean body weight of the 50,000 ppm females and the body weight gains of the 25,000 and 50,000 ppm females were significantly lower than those of the controls. The final mean body weights and mean body weight gains of all other exposed groups were similar to those of the controls. There was no cathartic action or any other clinical finding attributed to exposure to phenolphthalein. The few differences in the hematology and clinical chemistry parameters were sporadic and were not considered to be chemical related. The percentage of motile sperm in the 12,000 ppm males was significantly greater than that in the controls, but no other significant differences in sperm morphology or vaginal cytology between exposed and control groups were observed. Absolute and relative liver weights of 25,000 and 50,000 ppm males were significantly greater than those of the controls. No chemical-related gross or microscopic lesions were observed. 13-WEEK STUDY IN MICE: Groups of 10 male and 10 female B6C3F1 mice were given 0, 3,000, 6,000, 12,000, 25,000, or 50,000 ppm phenolphthalein (equivalent to average daily doses of approximately 500, 1,000, 2,000, 4,100, or 9,000 mg phenolphthalein/kg body weight to males and 600, 1,200, 2,400, 5,000, or 10,500 mg/kg to females) in feed for 13 weeks. All mice survived until the end of the study. The final mean body weights and mean body weight gains of all exposed groups were similar to those of the controls. There was no cathartic action or any other clinical finding attributed to exposure to phenolphthalein. The absolute right cauda weight of the 12,000 ppm males and the absolute right epididymis weights of 12,000, 25,000, and 50,000 ppm males were significantly less than those of the controls. The percentages of abnormal sperm in 12,000, 25,000, and 50,000 ppm males were significantly greater than that in the control group, and the sperm concentrations in 12,000 and 50,000 ppm males were significantly less than that of the control group. The absolute and relative right testis weights of males exposed to 6,000 ppm or greater and the absolute right testis weight of 3,000 ppm mof 3,000 ppm males were significantly less than those of the controls. The incidences of hypoplasia of the bone marrow in males and females exposed to 12,000 ppm or greater were significantly greater than those in the controls. The incidences of hematopoiesis of the spleen in 25,000 and 50,000 ppm males were significantly greater than that in the controls. 2-YEAR STUDY IN RATS: Groups of 50 male and 50 female F344/N rats were given 0, 12,000, 25,000, or 50,000 ppm phenolphthalein (equivalent to average daily doses of approximately 500, 1,000, or 2,000 mg phenolphthalein/kg body weight to males and 500, 1,000, or 2,500 mg/kg to females) in feed for 2 years. Survival, Body Weights, and Clinical Findings: Survival of exposed males and females was similar to that of the controls. The mean body weights of exposed males were less than those of the controls through most of the second year of the study, and the mean body weights of exposed females were less than those of the controls from about week 16 until the end of the study. Clinical findings attributed to phenolphthalein exposure included thin appearance and ruffled fur in all exposed groups of males. Determinations of Total Phenolphthalein in Plasma: The mean plasma concentrations of total phenolphthalein (free and conjugated) after 2 years of exposure varied little with time of day. Plasma concentrations of total phenolphthalein were approximately the same between exposure groups and between males and females. Pathology Findings: The incidences of benign pheochromocytoma of the adrenal medulla in all exposed groups of males were significantly greater than those in the controls and occurred with a significant positive trend. The incidences of benign pheochromocytoma in 12,000 ppm females and of benign or malignant pheochromocytoma (combined) in 12,000 and 25,000 ppm females were significantly greater than those in the controls. The numbers of exposed males with bilateral benign pheochromocytomas exceeded the number of controls with these neoplasms. The incidences of malignant pheochromocytomas in exposed rats were similar to those in the controls. The incidences of focal hyperplasia of the adrenal medulla in the 12,000 and 50,000 ppm males were significantly greater than in the controls. The incidences of renal tubule adenoma in 50,000 ppm male rats and of renal tubule adenoma or carcinoma (combined) in 12,000 and 50,000 ppm male rats were significantly greater than those in the controls. Although the increased incidences were predominantly of renal tubule adenoma, four carcinomas were observed in exposed males (0 ppm, 0/50; 12,000 ppm, 1/50; 25,000 ppm, 1/50; 50,000 ppm, 2/50). The incidences of renal tubule neoplasms in exposed groups of females were similar to those in the controls. The findings from an extended evaluation (step section) of the kidneys of female rats were similar to those from the standard evaluation. The incidences of nephropathy in all exposed groups of females were significantly greater than in the controls, and the severity of nephropathy in all exposed groups of males and in 25,000 and 50,000 ppm females was significantly greater than in the controls. The incidences of diffuse hyperplasia of the parathyroid gland (0/41, 16/48, 14/49, 14/46), fibrous osteodystrophy of the bone (0/50, 17/50, 14/50, 12/50), and mineralization (0/50, 11/50, 5/50, 5/49) and degeneration (0/50, 11/50, 5/50, 4/49) of the glandular stomach in exposed groups of males were generally significantly greater than those in the controls. The incidences of hyperplasia of the thyroid gland C-cells (13/50, 3/50, 9/49, 4/49) in 12,000 and 50,000 ppm males were significantly less than in the controls. These lesions are commonly observed in male rats with more advanced nephropathy and are considered to be associated with a calcium/phosphorus imbalance created by compromised functional capacity of the kidney. 2-YEAR STUDY IN MICE: Groups of 50 male and 50 female B6C3F1 mice were given 0, 3,000, 6,000, or 12,000 ppm phenolphthalein (equivalent to average daily doses of approximately 300, 600, or 1,200 mg phenolphthalein/kg body weight to males and 400, 800, or 1,500 mg/kg to females) in feed for 2 years. Survival, Body Weights, and Clinical Findings: Survival of the 12,000 ppm females was significantly lower than that of the controls; survival of all other exposed groups of mice was similar to that of the controls. The mean body weights of 12,000 ppm males were slightly less than those of the controls beginning at week 93 of the study, and the mean body weights of the 3,000, 6,000, and 12,000 ppm females were less than those of the controls during most of the second year of the study. In exposed mice, there were no clinical findings related to phenolphthalein exposure. Determinations of Total Phenolphthalein in Plasma: The mean plasma concentrations of total phenolphthalein (free and conjugated) after 2 years of exposure varied little with time of day. Plasma concentrations of total phenolphthalein were approximately the same between exposure groups and between males and females. Pathology Findings: The incidences of histiocytic sarcoma in 6,000 and 12,000 ppm males and females were significantly greater than those in the controls and occurred with a significant positive trend. In this study, histiocytic sarcoma was consistently observed in the liver with several other sites (e.g., spleen, lung, bone marrow, and various lymph nodes) involved less frequently. The incidences of all types of malignant lymphoma and of lymphoma of thymic origin in all exposed groups of females were significantly greater than those in the controls and occurred with significant positive trends, while the incidences of all types of malignant lymphoma in all exposed groups of males were similar to that in the controls. The incidences of lymphoma of thymic origin were increased in exposed groups of males, but were significantly increased only in the 6,000 ppm group. The incidences of atypical hyperplasia of the thymus in 6,000 and 12,000 ppm males and in all exposed groups of females were significantly greater than those in the controls. The incidences of benign sex-cord stromal tumors of the ovary in all exposed groups of females were significantly greater than in the controls. The incidences of hyperplasia of the ovary in 3,000 and 12,000 ppm females were significantly greater than in the controls. The incidences of germinal epithelial degeneration of the testis in all exposed groups of males were significantly greater than that in the controls. There were increased incidences of myelofibrosis of the bone marrow in 12,000 ppm males (0 ppm, 3/50; 3,000 ppm, 8/50; 6,000 ppm, 8/50; 12,000 ppm, 19/49) and an increased severity but not incidence of this lesion in exposed females. There were also increased incidences of pigmentation of minimal to mild severity in the bone marrow of 6,000 and 12,000 ppm males (0/50, 2/50, 5/50, 16/49) and females (2/50, 3/50, 11/50, 11/50). Also, the incidences of hematopoietic cell proliferation in the red pulp of the spleen (10/50, 22/50, 28/50, 21/49) in all exposed groups of males were significantly greater than that in the controls, and the severity of this lesion increased with increasing exposure concentration. The incidences of hepatocellular adenoma in all exposed groups of males and females and of hepatocellular adenoma or carcinoma (combined) in 6,000 and 12,000 ppm males and all exposed groups of females were significantly less than those in the controls, and these lesions occurred with significant negative trends. Multiple hepatocellular adenomas were observed more frequently in the control groups than in the exposed groups. The incidences of clear cell and eosinophilic foci in all exposed groups of males and of mixed cell foci in 12,000 ppm males were significantly less than those in the controls. The incidences of eosinophilic foci in exposed groups of females were significantly less than that in the controls. GENETIC TOXICOLOGY: Phenolphthalein, tested in two laboratories, was not mutagenic in any of four strains of Salmonella typhimurium with or without S9 metabolic activation enzymes, and no induction of sister chromatid exchanges was observed in cultured Chinese hamster ovary cells treated with phenolphthalein with or without S9. However, significant increases in chromosomal aberrations were observed after treatment of cultured Chinese hamster ovary cells with phenolphthalein in the presence of S9, and the frequencies of micronucleated erythrocytes were increased in peripheral blood samples from male and female mice administered phenolphthalein in feed for 13 weeks. CONCLUSIONS: Under the conditions of these 2-year feed studies, there was clear evidence of carcinogenic activity of phenolphthalein in male F344/N rats based on markedly increased incidences of benign pheochromocytomas of the adrenal medulla and of renal tubule adenomas and adenomas or carcinomas (combined). There was some evidence of carcinogenic activity of phenolphthalein in female F344/N rats based on the increased incidences of benign pheochromocytomas of the adrenal medulla in the 12,000 ppm group and of benign or malignant pheochromocytomas (combined) in the 12,000 and 25,000 ppm groups. There was clear evidence of carcinogenic activity of phenolphthalein in male B6C3F1 mice based on increased incidences of histiocytic sarcomas and of malignant lymphomas of thymic origin. There was clear evidence of carcinogenic activity of phenolphthalein in female B6C3F1 mice based on increased incidences of histiocytic sarcomas, malignant lymphomas of all types, lymphomas of thymic origin, and benign sex-cord stromal tumors of the ovary. Exposure of rats to phenolphthalein in feed for 2 years resulted in increased incidences of focal hyperplasia of the adrenal medulla in males and in increased incidences and/or severity of nephropathy of the kidney in males and females. Exposure of mice to phenolphthalein in feed for 2 years resulted in increased incidences of atypical hyperplasia of the thymus in males and females, degeneration of the germinal epithelium of the testis in males, and ovarian hyperplasia in females. Exposure of mice to phenolphthalein in feed for 2 years resulted in decreased incidences of hepatocellular neoplasms and nonneoplastic lesions in males and females. Synonyms: 3,3-Bis(4-hydroxyphenyl)-1(3H)-isobenzofuranone; 3,3-bis( p-hydroxyphenyl)phthalide; a-p -hydroxyphenyl)-a- (4-oxo-2,5-cyclohexadien-1-ylidene)- o-toluic acid Trade names: Agoral®, Alophen®, Colax®, Correctol®, Dialose®, Doxidan®, Espotabs®, Evac-U-Gen®, Evac-U-Lax®, Ex-Lax®, Feen-A-Mint®, FemiLax®, Kondremul®, LaxCaps®, Lax-Pills®, Medilax®, Modane®, Phenolax®, Prulet®
PubMed: 12579199
DOI: No ID Found -
Polymers Aug 2022Over the years, many materials have been used to restore buildings, paintings, ceramics, and mosaic pieces exhibiting different types of dyes and colour hues. Recently,...
Over the years, many materials have been used to restore buildings, paintings, ceramics, and mosaic pieces exhibiting different types of dyes and colour hues. Recently, geopolymers have been used for restoration purposes owing to their high chemical and mechanical resistance. In this work, white metakaolin was used to obtain white geopolymers, cured at 25 and 40 °C, as bulk materials to be coloured with synthetic organic dyes, i.e., bromothymol blue, cresol red, phenolphthalein, and methyl orange. These dyes were added during the fresh paste preparation to obtain dyed geopolymeric solids. Ionic conductivity and pH measurement confirmed the chemical stability of the consolidated materials, while FT-IR analyses were used to follow the geopolymerisation occurrences at different ageing times (from 7 to 56 days). Finally, the colour hues and properties were assessed in the CIELAB colour space before and after immersion in water.
PubMed: 36015635
DOI: 10.3390/polym14163380 -
ACS Omega Nov 2022The 7-nitro-2'-phenyl-5',6',7',7a'-tetrahydrospiro[indeno[1,2-]quinoxaline-11,3'-pyrrolizine]-1',1'(2')-dicarbonitrile (SIQPI),...
The 7-nitro-2'-phenyl-5',6',7',7a'-tetrahydrospiro[indeno[1,2-]quinoxaline-11,3'-pyrrolizine]-1',1'(2')-dicarbonitrile (SIQPI), 2'-(4-cyanophenyl)-7-nitro-5',6',7',7a'-tetrahydrospiro[indeno[1,2-]quinoxaline-11,3'-pyrrolizine]-1',1'(2') dicarbonitrile (SIQPII), and 2'-(4-methoxyphenyl)-7-nitro-5',6',7',7a'-tetrahydrospiro[indeno[1,2-]quinoxaline-11,3'-pyrrolizine]-1',1'(2')-dicarbonitrile (SIQPIII) were used to photocatalyze quinonoid phenolphthalein (QHIn) in aq-ACN-EtOH (mixed solvent) with NaCl and KCl electrolytes. SIQPI, II, and III spiroindenoquinoxaline pyrrolidines (SIQPs) as spiroheterocyclic photocatalysts alone could not reduce QHIn, but with the addition of electrolytes they are reduced via π cationic interactions (PCI). SIQPI, II, and III with NaCl reduced QHIn in 120, 28, and 50 min, unlike in 138, 58, and 63 min with KCl in mixed solvent. SIQPI, II, and III alone have reduced methylene blue (MB) in 120, 45, and 70 min, unlike in 110, 27, and 55 min with graphene oxide (GO), whereas with NaCl and KCl hey are reduced in 82, 36, and 44 min and 89, 43, and 50 min, respectively. SIQPs with GO had reduced MB in less time than the SIQPs alone, and SIQPs with NaCl had reduced QHIn in a shorter time than KCl. The electrolytes have cocatalyzed a reduction of dyes under sunlight (SL). The electrolytes have reduced a quinonoid structure (QS) and dyes by generating negative and positive ( and ) holes in a shorter time. SIQPII and magnetic nanoparticles (MNPs) of 58 nm with NaCl photocatalyzed the QHIn in 2880 min. The SIQPs also reduced methyl orange (MO) and brilliant blue R (BBR) at variable temperature () and pH range, whereas SIQPs have developed a molecular organic framework (MOF) with transition-metal salts (NiCl, CrO, KMnO, CuSO, and MnCl) on photocatalysis.
PubMed: 36385858
DOI: 10.1021/acsomega.2c05103 -
Molecules (Basel, Switzerland) Aug 2021Water pollution by various toxic substances remains a serious environmental problem, especially the occurrence of organic micropollutants including endocrine disruptors,...
Water pollution by various toxic substances remains a serious environmental problem, especially the occurrence of organic micropollutants including endocrine disruptors, pharmaceutical pollutants and naphthol pollutants. Adsorption process has been an effective method for pollutant removal in wastewater treatment. However, the thermal regeneration process for the most widely used activated carbon is costly and energy-consuming. Therefore, there has been an increasing need to develop alternative low-cost and effective adsorption materials for pollutant removal. Herein, β-cyclodextrin (β-CD), a cheap and versatile material, was modified with methacrylate groups by reacting with methacryloyl chloride, giving an average degree of substitution of 3 per β-CD molecule. β-CD-methacrylate, which could function as a crosslinker, was then copolymerized with acrylamide monomer via free-radical copolymerization to form β-CD-polyacrylamide (β-CD-PAAm) hydrogel. Interestingly, in the structure of the β-CD-PAAm hydrogel, β-CD is not only a functional unit binding pollutant molecules through inclusion complexation, but also a structural unit crosslinking PAAm leading to the formation of the hydrogel 3D networks. Morphological studies showed that β-CD-PAAm gel had larger pore size than the control PAAm gel, which was synthesized using conventional crosslinker instead of β-CD-methacrylate. This was consistent with the higher swelling ratio of β-CD-PAAm gel than that of PAAm gel (29.4 vs. 12.7). In the kinetic adsorption studies, phenolphthalein, a model dye, and bisphenol A, propranolol hydrochloride, and 2-naphthol were used as model pollutants from different classes. The adsorption data for β-CD-PAAm gel fitted well into the pseudo-second-order model. In addition, the thermodynamic studies revealed that β-CD-PAAm gel was able to effectively adsorb the different dye and pollutants at various concentrations, while the control PAAm gel had very low adsorption, confirming that the pollutant removal was due to the inclusion complexation between β-CD units and pollutant molecules. The adsorption isotherms of the different dye and pollutants by the β-CD-PAAm gel fitted well into the Langmuir model. Furthermore, the β-CD-PAAm gel could be easily recycled by soaking in methanol and reused without compromising its performance for five consecutive adsorption/desorption cycles. Therefore, the β-CD-PAAm gel, which combines the advantage of an easy-to-handle hydrogel platform and the effectiveness of adsorption by β-CD units, could be a promising pollutant removal system for wastewater treatment applications.
PubMed: 34443616
DOI: 10.3390/molecules26165031 -
Journal of Fluorine Chemistry Jul 2013The fluorination of phenolphthalein and naphtholphthalein was performed with diluted fluorine gas under acidic conditions. For both compounds we observed an...
The fluorination of phenolphthalein and naphtholphthalein was performed with diluted fluorine gas under acidic conditions. For both compounds we observed an electrophilic fluorination into ortho position to the hydroxyl group. Through the use of this reaction we synthesized and characterized mono-and difluorinated derivatives of phenolphthalein and naphtholphthalein. The compounds were also prepared in the F labeled form, which are usable as a new type of probe for pH measurement in biological objects using Cerenkov imaging or combination of light absorption and PET.
PubMed: 25411510
DOI: 10.1016/j.jfluchem.2013.03.021 -
Materials (Basel, Switzerland) Jul 2021In light of the scientific research, the corrosion of concrete structures is one of the main problems that may reduce their durability due to the negative impact of the...
In light of the scientific research, the corrosion of concrete structures is one of the main problems that may reduce their durability due to the negative impact of the natural environment. The paper analyzes the influence of the type of component on the selected properties of lightweight concrete subjected to the influence of aggressive liquids. Four concrete mixes were prepared with a granular aggregate made of foamed glass (GEGA) and aggregate made of sintered fly ash (GAA) with the use of a mineral additive: silica fly ash. The prepared lightweight concrete after one year was exposed for 60 days to the following environments: strong acid-HCl, 1% and 2% concentration, weak acid-CHCOOH, 1% and 2% concentration, and an aqueous salt solution of NaSO, 1% and 2% concentration. Then, the compressive strength was tested, and the microstructure analysis of the ready-made lightweight concrete (LWC) was performed. The degree of penetration of aggressive solutions into the cracks of the samples was assessed by means of applying 1% phenolphthalein solution. Changes in the weight of lightweight concrete samples after the test period were estimated. The obtained test results indicate that the decrease in the durability of lightweight concrete can be classified as a long-term process. Concrete with GEGA and GAA showed high resistance to aggressive environments. Moreover, the environment containing chlorides turned out to be the most aggressive, while the environment containing sulfates proved to be the least aggressive. The higher the concentration of the destructive factor was, the faster the corrosion process went. This has been proven by measuring the pH using phenolphthalein and carrying out microscopic examination. Concretes containing aggregates made of foamed glass and sintered fly ash are suitable for use both in traditional construction and in facilities exposed to an aggressive environment (e.g., in the chemical industry and at gas stations).
PubMed: 34361376
DOI: 10.3390/ma14154185 -
Croatian Medical Journal Aug 2023To assess the quantity and quality of incident reports on medical devices by health care professionals from 2012 to 2021 and evaluate the effect of reporting on...
AIM
To assess the quantity and quality of incident reports on medical devices by health care professionals from 2012 to 2021 and evaluate the effect of reporting on manufacturers' post-market surveillance.
METHODS
Eighty-five incident reports were scored according to a self-developed evaluation system, and categorized as excellent, good, medium, qualified, and unqualified. The completeness of data in critical fields was assessed. For each report, the type and city of the reporter, and medical device risk class were extracted to calculate the frequency of report occurrence per risk class and outcomes for reportable reports.
RESULTS
The number of reports received from health care professionals was low; the highest number of reports in a year was 17. The majority of reports were deemed as unqualified (61.18%) and only 4.71% as excellent. Still, 67.65% of incident reports importantly affected the manufacturer's post-market surveillance, either as added information that contributes to risk monitoring or directly triggering a field safety corrective action.
CONCLUSION
The number of total reports and reports per year shows extensive underreporting in Croatia, and the quality of the provided reports is insufficient.
Topics: Humans; Croatia; Dioctyl Sulfosuccinic Acid; Health Personnel; Phenolphthalein
PubMed: 37654038
DOI: 10.3325/cmj.2023.64.265 -
ACS Omega Jan 2019β-cyclodextrin (β-CD) forms a host-guest inclusion complex with many organic and amphiphilic compounds found in pharmaceutical, textile, cosmetic, food, and personal...
β-cyclodextrin (β-CD) forms a host-guest inclusion complex with many organic and amphiphilic compounds found in pharmaceutical, textile, cosmetic, food, and personal care systems. Therefore, grafting of β-CD onto a cellulose nanocrystal (CNC) offers a possible strategy to use functionalized CNC to complex with surface-active molecules. We have successfully grafted β-CD onto CNCs in a stepwise manner using cyanuric chloride as the linker. The structure of β-CD-grafted CNC (CNC-CD) was characterized by UV-vis and Fourier-transform infrared spectroscopy, and the grafting ratio of β-CD was determined by the phenolphthalein inclusion protocol. Ionic surfactants induced the aggregation of CNC-CDs by forming inclusion complexes with β-CDs on the surface of CNC. The interactions of amphiphilic compounds with CNC-CD were examined by surface tensiometry, conductometric and potentiometric titration, and isothermal titration calorimetry. Mechanisms describing the complex formation between surfactants and CNC-CD were proposed, where an improved understanding of CD interactions with surfactants and lipids would enable better strategies for drug encapsulation and delivery with CDs.
PubMed: 31459458
DOI: 10.1021/acsomega.8b02534 -
Drug Discoveries & Therapeutics Dec 2008Phenolphthalein is frequently used laxative drug since 1930s, but the possible teratogenic effect of phenolphthalein was not checked in casecontrol eptedmiological...
Phenolphthalein is frequently used laxative drug since 1930s, but the possible teratogenic effect of phenolphthalein was not checked in casecontrol eptedmiological study. In addition US Food and Drug Administration (FDA) declared the mutagenic and carcinogenic effect of phenolphthalein in 1999, thus we decided to evaluate the birth outcomes particularly congenital abnormalities (CAs) of newborn infants born to women treated with phenolphthalein during pregnancy. Cases with CA and their matched controls without CA born to mothers with phenolphthalein use during pregnancy were compared in the population-based large data set of the Hungarian Case-Control Surveillance System of Congenital Abnormalities. Of 22,843 cases with CA, 191 (0.83%) while of 38,151 controls, 247 (0.64%) were born to mothers with phenolphthalein treatment (adjusted OR with 95% CI: 1.3, 1.0-1.5). The mean gestational week at delivery was somewhat longer in both the case (0.3 week) and control (0.2 week) groups while the mean birth weight was somewhat larger in cases (46 g) and controls (12 g) born to mothers with phenolphthalein treatment during the study pregnancy compared with mothers without phenolphthalein treatment. These differences were in agreement with the lower rate of preterm births and low birth weight in controls born to mothers with phenolphthalein treatment during pregnancy. The detailed analysis of different CA groups showed an association between maternal phenolphthalein treatment during pregnancy and a higher risk for Hirschsprung's disease (p = 0.01) based on 4 cases in the so-called other isolated CA-group. In conclusion phenolphthalein treatment in pregnant women associates with a higher risk for Hirschsprung's disease in their children, but this finding is only a signal which needs confirmation or rejection in other studies.
PubMed: 22504746
DOI: No ID Found -
IARC Monographs on the Evaluation of... 2000
Review
Topics: Animals; Antineoplastic Agents; Antisickling Agents; Carcinogens; Cathartics; Disease Models, Animal; Evidence-Based Medicine; Humans; Hydroxyurea; Indicators and Reagents; Intestinal Absorption; Neoplasms; Nucleic Acid Synthesis Inhibitors; Phenolphthalein; Research Design; Risk Factors; Tissue Distribution; Vitamin K
PubMed: 11000977
DOI: No ID Found