scholarly journals Safety Assessment of Castoreum Extract as a Food Ingredient

2007 ◽  
Vol 26 (1) ◽  
pp. 51-55 ◽  
Author(s):  
G. A. Burdock
Keyword(s):  
Antibacterial Activity ◽  
Human Subject ◽  
Safety Assessment ◽  
Adverse Reactions ◽  
Skin Sensitization ◽  
Scent Glands ◽  
Food Ingredient ◽  
Routes Of Administration ◽  
Weak Antibacterial Activity

Castoreum extract (CAS NO. 8023–83–4; FEMA NO. 2261) is a natural product prepared by direct hot-alcohol extraction of castoreum, the dried and macerated castor sac scent glands (and their secretions) from the male or female beaver. It has been used extensively in perfumery and has been added to food as a flavor ingredient for at least 80 years. Both the Flavor and Extract Manufacturers Association (FEMA) and the Food and Drug Administration (FDA) regard castoreum extract as generally recognized as safe (GRAS). Acute toxicity studies in animals indicate that castoreum extract is nontoxic by both oral and dermal routes of administration and is not irritating or phototoxic to skin. Skin sensitization has not been observed in human subject tests. Castoreum extract possesses weak antibacterial activity. A long historical use of castoreum extract as a flavoring and fragrance ingredient has resulted in no reports of human adverse reactions. On the basis of this information, low-level, long-term exposure to castoreum extract does not pose a health risk. The objective of this review is to evaluate the safety-in-use of castoreum extract as a food ingredient.

2 Final Report on the Safety Assessment of p-Hydroxyanisole

1985 ◽  
Vol 4 (5) ◽  
pp. 31-63 ◽  
Keyword(s):  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Tumor Promoter ◽  
Final Report ◽  
Skin Sensitization ◽  
Cosmetic Products ◽  
Rabbit Skin ◽  
Ames Assay

p-Hydroxyanisole is used as an antioxidant in cosmetic products at concentrations of up to 1.0 percent. The acute oral LD50 of p-Hydroxyanisole in rats was estimated as 1630 mg/kg. Undiluted p-Hydroxyanisole is a severe skin and ocular irritant in rabbits but produced minimal eye irritation at 0.1 percent and minimal rabbit skin irritation at 5 percent. Skin sensitization to p-Hydroxyanisole occurred when guinea pigs were treated at 0.5 M. p-Hydroxyanisole is a skin-depigmenting agent at concentrations approximating those used in cosmetic products. p-Hydroxyanisole was nonmutagenic in the Ames assay. No local toxic changes or tumors were observed following long-term application of 5 and 10 percent p-Hydroxyanisole. The antioxidant was inactive as a tumor promoter. Solutions of p-Hydroxyanisole produced embryotoxicity but not teratogenicity. The function of p-Hydroxyanisole in cosmetics is that of an antioxidant; it is not intended for use as a skin lightener or skin-depigmenting agent. Because of the depigmenting action of p-Hydroxyanisole in black guinea pigs at reported concentrations approaching those used in cosmetics, it is concluded that p-Hydroxyanisole is unsafe for use as a cosmetic ingredient.

scholarly journals Comparable Long-Term Rabies Immunity in Foxes after IntraMuscular and Oral Application Using a Third-Generation Oral Rabies Virus Vaccine

Vaccines ◽  
2021 ◽  
Vol 9 (1) ◽  
pp. 49
Author(s):  
Verena te Kamp ◽  
Virginia Friedrichs ◽  
Conrad M. Freuling ◽  
Ad Vos ◽  
Madlin Potratz ◽  
...  
Keyword(s):  
Immune Response ◽  
Rabies Virus ◽  
Specific Binding ◽  
Lethal Dose ◽  
Genetically Engineered ◽  
Routes Of Administration ◽  
Safety Studies ◽  
Oral Rabies Vaccine ◽  
Cellular Immune

The live genetically-engineered oral rabies virus (RABV) variant SPBN GASGAS induces long-lasting immunity in foxes and protection against challenge with an otherwise lethal dose of RABV field strains both after experimental oral and parenteral routes of administration. Induction of RABV-specific binding antibodies and immunoglobulin isotypes (IgM, total IgG, IgG1, IgG2) were comparable in orally and parenterally vaccinated foxes. Differences were only observed in the induction of virus-neutralizing (VNA) titers, which were significantly higher in the parenterally vaccinated group. The dynamics of rabies-specific antibodies pre- and post-challenge (365 days post vaccination) suggest the predominance of type-1 immunity protection of SPBN GASGAS. Independent of the route of administration, in the absence of IgG1 the immune response to SPBN GAGAS was mainly IgG2 driven. Interestingly, vaccination with SPBN GASGAS does not cause significant differences in inducible IFN-γ production in vaccinated animals, indicating a relatively weak cellular immune response during challenge. Notably, the parenteral application of SPBN GASGAS did not induce any adverse side effects in foxes, thus supporting safety studies of this oral rabies vaccine in various species.

1 Final Report on the Safety Assessment of Isostearyl Neopentanoate

1985 ◽  
Vol 4 (3) ◽  
pp. 1-22 ◽  
Keyword(s):  
Test Data ◽  
Clinical Studies ◽  
Safety Assessment ◽  
Final Report ◽  
Cosmetic Products ◽  
Short And Long Term ◽  
Cosmetic Formulation

Isostearyl Neopentanoate, the ester of Isostearyl Alcohol and Neopentanoic Acid, is used in cosmetic products as an emollient at concentrations up to 50 percent. The undiluted ingredient at doses up to 4 ml/kg was shown to be relatively non-toxic in short-and long-term feeding studies. Test data from animal and clinical studies indicate the undiluted ingredient is neither an irritant nor a sensitizer. A cosmetic formulation containing 16 percent Isostearyl Neopentanoate produced no phototoxicity and no photoallergenicity. Mutagenicity, carcinogenicity, and teratogenicity data were not available. Isostearyl Neopentanoate was not considered to be a significant comedogenic agent. On the basis of available data, it is concluded that this ingredient is safe as a cosmetic ingredient in its present practices of use.

Structural Safety Assessment of a 1100 TEU Container Ship, Based on a Enhanced Long Term Fatigue Analysis

2014 ◽  
Vol 1036 ◽  
pp. 935-940
Author(s):  
Leonard Domnisoru ◽  
Ionica Rubanenco ◽  
Mihaela Amoraritei
Keyword(s):  
Safety Assessment ◽  
Safety Evaluation ◽  
Irregular Waves ◽  
Structural Safety ◽  
Random Wave ◽  
Wave Loads ◽  
Strength Assessment ◽  
Integrated Method ◽  
Hydroelastic Response

This paper is focused on an enhanced integrated method for structural safety assessment of maritime ships under extreme random wave loads. In this study is considered an 1100 TEU container test ship, with speed range 0 to 18 knots. The most comprehensive criteria for ships structural safety evaluation over the whole exploitation life is based on the long term ship structures analysis, that includes: stress hot-spots evaluation by 3D/1D-FEM hull models, computation of short term ship dynamic response induced by irregular waves, long term fatigue structure assessment. The analysis is enhanced by taking into account the ships speed influence on hydroelastic response. The study includes a comparative analysis on two scenarios for the correlation between the ships speed and waves intensity. The standard constant ship speed scenario and CENTEC scenario, with total speed loss at extreme waves condition, are considered. Instead of 20 years ship exploitation life estimated by classification societies rules from the long term structural safety criteria, the enhanced method has predicted more restrictive values of 14.4-15.7 years. The numerical analyses are based on own software and user subroutines. The study made possible to have a more realistic approach of ships structural strength assessment, for elastic and faster ships as container carriers, in compare to the standard one based only on naval rules, delivering a method with higher confidence in the designed structural safety.

Safety Assessment of Long Term Serviced Pressure Vessels: A Case Study of Typical Refining and Chemical Plants in China

2021 ◽  
Author(s):  
Zhiyuan Han ◽  
Guoshan Xie ◽  
Haiyi Jiang ◽  
Xiaowei Li
Keyword(s):  
Pressure Vessel ◽  
Safety Assessment ◽  
Failure Modes ◽  
Pressure Vessels ◽  
Time Dependent ◽  
Chemical Plants ◽  
Safety Specification ◽  
Detailed Assessment

Abstract The safety and risk of the long term serviced pressure vessels, especially which serviced more than 20 years, has become one of the most concerned issues in refining and chemical industry and government safety supervision in China. According to the Chinese pressure vessel safety specification TSG 21-2016 “Supervision Regulation on Safety Technology for Stationary Pressure Vessel”, if necessary, safety assessment should be performed for the pressure vessel which reaches the design service life or exceeds 20 years without a definite design life. However, the safety and risk conditions of most pressure vessels have little changes after long term serviced because their failure modes are time-independent. Thus the key problem is to identify the devices with the time-dependent failure modes and assess them based on the failure modes. This study provided a case study on 16 typical refining and chemical plants including 1870 pressure vessels serviced more than 20 years. The quantitative risk and damage mechanisms were calculated based on API 581, the time-dependent and time-independent failure modes were identified, and the typical pressure vessels were assessed based on API 579. Taking the high pressure hydrogenation plant as an example, this study gave the detailed assessment results and conclusions. The results and suggestions in this study are essential for the safety supervision and extending life of long term serviced pressure vessels in China.

A Case of Gastric Cancer in Which Long-Term Administration of 5′-Deoxy-5-Fluorouridine Proved Effective

1989 ◽  
Vol 17 (2) ◽  
pp. 179-184
Author(s):  
T. Koda ◽  
T. Kurahori ◽  
N. Iwao ◽  
S. Sumi ◽  
T. Sonoda ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Reactions ◽  
Substantial Improvement ◽  
Term Treatment ◽  
Borrmann Type ◽  
Long Term Treatment ◽  
Term Administration ◽  
Stopping Treatment ◽  
Lesser Curvature

A patient diagnosed with Borrmann type 4 gastric cancer (mucinous adenocarcinoma), who had refused surgery, was treated by oral administration of 1200 mg/day 5′-deoxy-5-fluorouridine for about 23 weeks. This resulted in substantial improvement of her condition, i.e. the tumour almost completely disappeared, distensibility improved between the central region of the corpus ventriculi and the angulus, and only small protrusions remained on the anterior and posterior walls and the pars pylorica of the lesser curvature. Mild anorexia and diarrhoea were noted as adverse reactions although these symptoms subsided by reducing the dose or temporarily stopping treatment, thereby allowing long-term treatment. Long-term use of 5′-deoxy-5-fluorouridine proved temporarily effective in this patient. The patient died about 3 years and 7 months after starting therapy. Examination showed that the cancer had been mainly in the stomach and that it had metastasized to the colon and pancreas. The liver was free of metastasis.

ADVERSE REACTIONS TO TETRACYCLINE, PENICILLIN AND AN OLEANDOMYCIN-PENICILLIN MIXTURE USED IN THE LONG-TERM THERAPY OF CHRONIC PULMONARY DISEASE

1962 ◽  
Vol 243 (3) ◽  
pp. 341-353 ◽  
Author(s):  
Solomon Sobel ◽  
Edward A. Lichter ◽  
J Calvin Davis ◽  
Harry F. Dowling ◽  
Mark H. Lepper ◽  
...  
Keyword(s):  
Pulmonary Disease ◽  
Adverse Reactions ◽  
Term Therapy ◽  
Chronic Pulmonary Disease ◽  
Long Term Therapy

Methenamine Hippurate (‘Hiprex’)† in the Treatment of Chronic Urinary Tract Infections: A Trial in a Geriatric Hospital

1976 ◽  
Vol 4 (2) ◽  
pp. 111-114 ◽  
Author(s):  
Salme Parvio
Keyword(s):  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Adverse Reactions ◽  
Bacterial Resistance ◽  
Term Treatment ◽  
Chronic Urinary Tract Infection ◽  
Long Term Treatment ◽  
Geriatric Hospital ◽  
Tract Infections

Fifty-two patients, all of whom were more than 66 years-old and who were hospitalized for periods in excess of two years were treated for chronic urinary tract infection. All patients received a course of antibiotic treatment for seven to ten days and were then put onto treatment with methenamine hippurate 1 g twice daily for six months. Of the original fifty-two patients, twelve did not complete the six month course. During the six month period with ‘Hiprex’ there were far fewer re-infections than in the previous six months during which time they had received intermittent antibiotic therapy and other long-term treatment. There were no adverse reactions and bacterial resistance did not occur.

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