Final Report on the Safety Assessment of Potassium Silicate, Sodium Metasilicate, and Sodium Silicate1

2005 ◽  
Vol 24 (1_suppl) ◽  
pp. 103-117 ◽  

Potassium Silicate, Sodium Metasilicate, and Sodium Silicate combine metal cations with silica to form inorganic salts used as corrosion inhibitors in cosmetics. Sodium Metasilicate also functions as a chelating agent and Sodium Silicate as a buffering and pH adjuster. Sodium Metasilicate is currently used in 168 formulations at concentrations ranging from 13% to 18%. Sodium Silicate is currently used in 24 formulations at concentrations ranging from 0.3% to 55%. Potassium Silicate and Sodium Silicate have been reported as being used in industrial cleaners and detergents. Sodium Metasilicate is a GRAS (generally regarded as safe) food ingredient. Aqueous solutions of Sodium Silicate species are a part of a chemical continuum of silicates based on an equilibrium of alkali, water, and silica. pH determines the solubility of silica and, together with concentration, determines the degree of polymerization. Sodium Silicate administered orally is readily absorbed from the alimentary canal and excreted in the urine. The toxicity of these silicates has been related to the molar ratio of SiO2/Na2O and the concentration being used. The Sodium Metasilicate acute oral LD50 ranged from 847 mg/kg in male rats to 1349.3 mg/kg in female rats and from 770 mg/kg in female mice to 820 mg/kg in male mice. Gross lesions of variable severity were found in the oral cavity, pharynx, esophagus, stomach, larynx, lungs, and kidneys of dogs receiving 0.25 g/kg or more of a commercial detergent containing Sodium Metasilicate; similar lesions were also seen in pigs administered the same detergent and dose. Male rats orally administered 464 mg/kg of a 20% solution containing either 2.0 or 2.4 to 1.0 ratio of sodium oxide showed no signs of toxicity, whereas doses of 1000 and 2150 mg/kg produced gasping, dypsnea, and acute depression. Dogs fed 2.4 g/kg/day of Sodium Silicate for 4 weeks had gross renal lesions but no impairment of renal function. Dermal irritation of Potassium Silicate, Sodium Metasilicate, and Sodium Silicate ranged from negligible to severe, depending on the species tested and the molar ratio and concentration tested. Sodium Metasilicate was negative in the local lymph node assay (LLNA), but a delayed-type hypersensitivity response was observed in mice. Potassium Silicate was nonirritating in two acute eye irritation studies in rabbits. Sodium Metasilicate (42.4% H20) was corrosive to the rabbit eye. Sodium Silicate was a severe eye irritant in some eye irritation studies, but was irritating or nonirritating in others. A skin freshener containing Sodium Silicate was nonirritating. Sodium Metasilicate was nonmutagenic in bacterial cells. Rats given Sodium Silicate (600 and 1200 ppm of added silica) in the drinking water in reproductive studies produced a reduced number of offspring: to 67% of controls at 600 ppm and to 80% of controls at 1200 ppm. Three adult rats injected intratesticularly and subcutaneously with 0.8 mM/kg of Sodium Silicate showed no morphological changes in the testes and no effect on the residual spermatozoa in the ductus deferens. Sodium Metasilicate (37% in a detergent) mixed with water was a severe skin irritant when tested on intact and abraded human skin, but 6%, 7%, and 13% Sodium Silicate were negligible skin irritants to intact and abraded human skin. Sodium Silicate (10% of a 40% aqueous solution) was negative in a repeat-insult predictive patch test in humans. The same aqueous solution of Sodium Silicate was considered a mild irritant under normal use conditions in a study of cumulative irritant properties. The Cosmetic Ingredient Review (CIR) Expert Panel recognized the irritation potential of these ingredients, especially in leave-on products. However, because these ingredients have limited dermal absorption and Sodium Metasilicate is a GRAS direct food substance, the Panel deemed the ingredients safe for use in cosmetic products in the practices of use and concentration described in this safety assessment, when formulated to avoid irritation.

Author(s):  
К.К. ДАВЫДОВ ◽  
В.В. ДЕРЕВЕНКО ◽  
Л.В. БОРОВСКАЯ

Проведен аналитический обзор способов очистки предварительно обработанных в электромагнитном поле нерафинированных и гидратированных растительных масел растворами органических кислот и силиката натрия. Исследовано влияние технологических параметров – температуры процесса очистки, концентрации и дозировки водного раствора метасиликата натрия заданной концентрации с силикатным модулем 1,0 (мольное соотношение SiO2/Na2O) на изменение качественных показателей получаемого масла. Объектом исследования было нерафинированное кукурузное масло, полученное двукратным прессованием из кукурузного зародыша, произведенного мокрым способом отделения, со следующими показателями: кислотное число 3,7 мг КОН/г, массовая доля фосфорсодержащих веществ 1,77% в пересчете на стеароолеолецитин, перекисное число 4,5 ммоль активного кислорода/кг, цветное число 70 мг йода, массовая доля влаги и летучих веществ 0,2%. Цветное число полученного кукурузного масла во всех опытах составляло 30 мг йода, а массовая доля влаги – 0,1–0,15%. Эксперимент проводили по трехфакторному плану Бокса–Бенкина. Получены адекватные экспериментально-статистические модели для расчета степени выведения жирных кислот и фосфорсодержащих веществ, перекисного числа и содержания мыла, позволяющие определить концентрацию и дозировку водного раствора силиката натрия при заданной температуре процесса для получения кукурузного масла с требуемыми показателями качества. Проведена оценка степени влияния исследованных факторов сравнительным ранжированием однофакторных зависимостей при стабилизации остальных факторов в координатах зоны наилучшего выхода. Установлено влияние температуры процесса, концентрации и дозировки водного раствора силиката натрия на эффективность выведения сопутствующих веществ. Показано, что при снижении температуры процесса до 50°С достигается выведение свободных жирных кислот до 0,96 и фосфорсодержащих веществ до 0,92. An analytical review of methods for cleaning unrefined and hydrated vegetable oils pretreated in an electromagnetic field with solutions of organic acids and sodium silicate was conducted. Influence of technological parameters – temperature cleaning process, the concentration and dosage of an aqueous solution of sodium metasilicate given concentration with silicate module 1.0 (the molar ratio SiO2/Na2O) on the change in quality parameters of oils are studied. Unrefined corn oil obtained by a double pressing of corn germ produced by wet way of separation, with the following parameters: acid number 3,7 mg KOH/g, mass fraction of phosphor containing substances of 1,77% in calculation on stearooleocytin, peroxide value 4,5 mmol of active oxygen/kg, the colour value 70 mg of iodine, the mass fraction of moisture and volatile matter 0,2% – was the object of the study. The color number of the obtained corn oil in all experiments was 30 mg of iodine, and the mass fraction of moisture – 0,1–0,15%. The experiment was performed according to the three–factor Box–Benkin plan. Adequate experimental and statistical models for calculating the degree of excretion of fatty acids and phosphorous-containing substances, the peroxide number and soap content, allowing to determine the concentration and dosage of an aqueous solution of sodium silicate at a given process temperature for obtaining corn oil with the required quality indicators, were obtained. The assessment of the degree of influence of the studied factors by comparative ranking of one-factor dependencies with the stabilization of other factors in the coordinates of the zone of the best output is carried out. The effect of the process temperature, concentration and dosage of an aqueous solution of sodium silicate on the efficiency of excretion of concomitant substances is established. It is shown that when the process temperature is reduced to 50°C, the removal of free fatty acids to 0,96 and phosphorus-containing substances to 0,92 is achieved.


1993 ◽  
Vol 12 (2) ◽  
pp. 145-154 ◽  
Author(s):  
Rodney J. Boatman ◽  
Daniel B. Schum ◽  
Derek Guest ◽  
Carol R. Stack

Human dermal exposure to diethylene glycol butyl ether (DGBE) and its acetate derivative (DGBA) may occur through contact with a variety of commercial products. Absorption and elimination of dermally applied doses of 14C-DGBE and 14C-DGBA were determined in Sprague-Dawley rats. The materials were applied under occlusion for 24 hr at dose levels of 0.2 and 2.0 g/kg (undiluted) and as a 10% aqueous solution (0.2 g/kg DGBE). Preliminary washing efficiency studies with soap and water indicated that greater than 89% of each chemical could be removed from rat skin following 5-min exposures. Female rats excreted a larger proportion of the applied dose of DGBE than did male rats. Similar results were obtained with the low dose of DGBE applied neat or as a 10% aqueous solution, suggesting that the low dose represents a saturating dose. The total recovered 14C for all studies with 14C-DGBE ranged from 83% to 89%, with 14C-DGBA, from 80% to 88%. Urinary excretion accounted for the majority of recovered 14C in all studies. The acid, 2-(2-butoxyethoxy)acetate acid was the major urinary metabolite identified. The glucuronide of DGBE was present at levels of from 5.2 to 8.2% of the urinary 14C. The dermal absorption rates were estimated to be 1.58 (DGBA, male), 1.28 (DGBA, female), 0.73 (DGBE, male), and 1.46 (DGBE, female), expressed as mg/cm2/hr.


1986 ◽  
Vol 5 (3) ◽  
pp. 225-248

Cosmetic grade Petroleum Distillate consists predominantly of C10-C16 paraffinic, naphthenic, and isoparaffinic hydrocarbons. The Distillate is used in a variety of cosmetic products at concentrations up to 50%. Undiluted Petroleum Distillate had an acute oral LD50 in rats of >25 ml/kg. Subchronic animal tests on a formulation containing 41.75% Petroleum Distillate were uneventful. Moderate skin irritation and mild, transient eye irritation were observed in rabbits following a single exposure to undiluted Petroleum Distillate. Cosmetic formulations containing 29.2–55% Petroleum Distillate were generally nonirritating, nonsensitizing, and nonphotosensitizing to human skin. It is concluded that Petroleum Distillate, as characterized in the report, is safe as a cosmeticingredient at the current concentrations of use.


1991 ◽  
Vol 10 (1) ◽  
pp. 67-85 ◽  

Pyrogallol, a benzenetriol, is used in oxidative hair dyes at concentrations ranging from ≤0.1 to 5.0%. The oral LD50's in rats ranged from 800 to 1270 mg/kg. Pyrogallol was not an ocular irritant when tested at a concentration of 1%. It was slightly irritating and induced sensitization reaction in the skin of guinea pigs. Sensitization reactions were noted in 3 of 25 patients patch tested with Pyrogallol. Significant teratogenic effects were not observed in the offspring of female rats dosed with Pyrogallol. No treatment-related effects were observed in a multigeneration reproductive toxicity study in which rats received dermal applications of a hair dye containing 0.4% Pyrogallol. Pyrogallol was mutagenic in almost all systems tested. However, in two carcinogenicity studies, the number of neoplasms in mice dermally treated with 50% Pyrogallol in acetone was not significantly different from that of controls. Similar results were reported in a carcinogenicity study in which a hair dye containing 0.49% Pyrogallol and H2O2 in aqueous solution was applied to the skins of mice. On the basis of the available animal and clinical data presented in this report, it is concluded that Pyrogallol is safe as a cosmetic ingredient in the present practices of use and concentration.


1973 ◽  
Vol 74 (1) ◽  
pp. 88-104 ◽  
Author(s):  
T. Jolín ◽  
M. J. Tarin ◽  
M. D. Garcia

ABSTRACT Male and female rats of varying ages were placad on a low iodine diet (LID) plus KClO4 or 6-propyl-2-thiouracil (PTU) or on the same diet supplemented with I (control rats). Goitrogenesis was also induced with LID plus PTU in gonadectomized animals of both sexes. The weight of the control and goitrogen treated animals, and the weight and iodine content of their thyroids were determined, as well as the plasma PBI, TSH, insulin and glucose levels. The pituitary GH-like protein content was assessed by disc electrophoresis on polyacrylamide gels. If goitrogenesis was induced in young rats of both sexes starting with rats of the same age, body weight (B.W.) and pituitary growth hormone (GH) content, it was found that both the males and females developed goitres of the same size. On the contrary, when goitrogenesis was induced in adult animals, it was found that male rats, that had larger B.W. and pituitary GH content than age-paired females, developed larger goitres. However, both male and female rats were in a hypothyroid condition of comparable degree as judged by the thyroidal iodine content and the plasma PBI and TSH levels. When all the data on the PTU or KClO4-treated male and female rats of varying age and B.W. were considered together, it was observed that the weights of the thyroids increased proportionally to B.W. However, a difference in the slope of the regression of the thyroid weight over B.W. was found between male and female rats, due to the fact that adult male rats develop larger goitres than female animals. In addition, in the male rats treated with PTU, gonadectomy decreased the B.W., pituitary content of GH-like protein and, concomitantly, the size of the goitre decreased; an opposite effect was induced by ovariectomy on the female animals. However, when goitrogenesis was induced in weight-paired adult rats of both sexes, the male animals still developed larger goitres than the females. Among all the parameters studied here, the only ones which appeared to bear a consistent relationship with the size of the goitres in rats of different sexes, treated with a given goitrogen, were the rate of body growth and the amount of a pituitary GH-like protein found before the onset of the goitrogen treatment. Moreover, though the pituitary content of the GH-like protein decreased as a consequence of goitrogen treatment, it was still somewhat higher in male that in female animals. The present results suggest that GH may somehow be involved in the mechanism by which male and female rats on goitrogens develop goitres of different sizes, despite equally high plasma TSH levels.


1971 ◽  
Vol 67 (3) ◽  
pp. 517-530 ◽  
Author(s):  
Martin Wenzel

ABSTRACT With the aid of metenolon-17α-T a tritium-transfer to oestrone in rat liver slices was demonstrated. This tritium-transfer from metenolon17α-T to oestrone yielding tritium-labelled oestradiol had a higher efficiency in male than in female rat liver. Correspondingly in the presence of metenolon the relation of oestrone to oestradiol is changed more in male than in female rat liver. Looking for biochemical differences between the anabolic steroid metenolon and testosterone the oxydation at C17 was measured in different organs of the rat using 17α-T-labelled steroids. The highest oxydation rate was found for both steroids in the liver. In the sexual organs of male rats the oxydation rate of testosterone was 50–10 times higher than that of the anabolic steroid. This difference was less in sexual organs of female rats. This result of a greater biochemical difference between both steroids in males than in females leads to the question, whether the dissociation between the anabolic and the androgen effects is higher in males than in females.


2019 ◽  
Vol 20 (1) ◽  
pp. 75-84

Disturbances in early pregnancy immunity affect embryo development, endometrial receptivity, placental development, fetal growth and lead to subfertility, dexamethasone is a synthetic glucocorticoid used for treatment of various complications. Immune cells and cytokines were examined during the early pregnancy in twenty-four female rats and six male rats for mating. Rats were grouped into two group control and dexamethasone treated by a dose of 50µgm/kgm body weight daily starting from one week before mating and persisted for one week after pregnancy. Blood samples were collected from each rat at 5hrs and at 1,3,7 day of pregnancy. Extracted RNA was subjected to real time PCR to determine mRNA levels for immune related genes interleukin1a(IL1A) and interleukin 10(IL10). Histopathological examination was done to uterus in order to detect leukocyte infiltration in uterine tissue. Results showed that significant increase in white blood cell count mainly eosinophil at 5hrs and lymphocyte at three and seven day of pregnancy of dexamethasone treated group. Moreover, TNF, C-reactive protein and progesterone were increased mainly at seven day of pregnancy of dexamethasone treated group. Similarly, interleukin 1alpha and interleukin 10 significantly increased at 5hrs and one day of pregnancy of dexamethasone treated group. In contrast, serum levels of total antioxidant capacity and estrogen were decreased significantly at 5hrs and seven day in dexamethasone treated group. Histopathological examination of uterus revealed leukocytic infiltration especially neutrophil and few eosinophils at five hours and one day of gestation then eosinophil become absent at 3day and seven day of dexamethasone group. Epithelial height and uterine gland diameter significantly increased at 5hrs, three day and seven days of gestation of dexamethasone treated group. The present investigation demonstrated that using of dexamethasone by dose of 50µgm/kgm during early pregnancy had a conflicting impact on some immune cytokines and parameters and may reflect a harmful response of immune system toward early period of pregnancy


Author(s):  
Steven T. Pittenger ◽  
Shinnyi Chou ◽  
Nathen J. Murawski ◽  
Scott T. Barrett ◽  
Olivia Loh ◽  
...  
Keyword(s):  

2021 ◽  
Vol 22 (7) ◽  
pp. 3762
Author(s):  
Sarah M. Kedziora ◽  
Kristin Kräker ◽  
Lajos Markó ◽  
Julia Binder ◽  
Meryam Sugulle ◽  
...  

Preeclampsia (PE) is characterized by the onset of hypertension (≥140/90 mmHg) and presence of proteinuria (>300 mg/L/24 h urine) or other maternal organ dysfunctions. During human PE, renal injuries have been observed. Some studies suggest that women with PE diagnosis have an increased risk to develop renal diseases later in life. However, in human studies PE as a single cause of this development cannot be investigated. Here, we aimed to investigate the effect of PE on postpartum renal damage in an established transgenic PE rat model. Female rats harboring the human-angiotensinogen gene develop a preeclamptic phenotype after mating with male rats harboring the human-renin gene, but are normotensive before and after pregnancy. During pregnancy PE rats developed mild tubular and glomerular changes assessed by histologic analysis, increased gene expression of renal damage markers such as kidney injury marker 1 and connective-tissue growth factor, and albuminuria compared to female wild-type rats (WT). However, four weeks postpartum, most PE-related renal pathologies were absent, including albuminuria and elevated biomarker expression. Only mild enlargement of the glomerular tuft could be detected. Overall, the glomerular and tubular function were affected during pregnancy in the transgenic PE rat. However, almost all these pathologies observed during PE recovered postpartum.


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