Paving Asphalt Products Exhibit a Lack of Carcinogenic and Mutagenic Activity

2011 ◽  
Vol 30 (5) ◽  
pp. 492-497 ◽  
Author(s):  
Katy O. Goyak ◽  
Richard H. McKee ◽  
Gary D. Minsavage ◽  
Claude McGowan ◽  
Wayne C. Daughtrey ◽  
...  
Keyword(s):  
Vacuum Distillation ◽  
Mutagenic Activity ◽  
Mineral Oil ◽  
Positive Control ◽  
Skin Carcinogenesis ◽  
Test Method ◽  
Mutagenic Potential ◽  
Induced Tumors ◽  
Paving Asphalt ◽  
C3h Mice

A paving asphalt and a vacuum residuum (derived from crude oil by atmospheric and subsequent vacuum distillation and used as a blend stock for asphalt) were tested in skin carcinogenesis assays in mice and in optimized Ames assays for mutagenic activity. In the skin cancer tests, each substance was applied twice weekly for 104 weeks to the clipped backs of groups of 50 male C3H mice. Neither the paving asphalt nor the vacuum residuum (30% weight/volume and 75% weight/weight in US Pharmacopeia mineral oil, respectively) produced any tumors. The positive control benzo[a]pyrene (0.05% w/v in toluene) induced tumors in 46 of 50 mice, demonstrating the effectiveness of the test method. Salmonella typhimurium tester strain TA98 was used in the optimized Ames assay to evaluate mutagenic potential. Dimethylsulfoxide (DMSO) extractions of the substances were not mutagenic when tested up to toxic limits. Thus, under the conditions of these studies, neither the paving asphalt nor the vacuum residuum was carcinogenic or mutagenic.

scholarly journals Mutagenicity evaluation of Anastatica hierochuntica L. aqueous extract in vitro and in vivo

2017 ◽  
Vol 243 (4) ◽  
pp. 375-385 ◽  
Author(s):  
Siti Rosmani Md Zin ◽  
Zahurin Mohamed ◽  
Mohammed A Alshawsh ◽  
Won F Wong ◽  
Normadiah M Kassim
Keyword(s):  
Aqueous Extract ◽  
Positive Control ◽  
In Vitro Assay ◽  
In Vivo Study ◽  
Sufficient Evidence ◽  
Aqueous Extracts ◽  
Mutagenic Potential ◽  
Vitro Assay

Anastatica hierochuntica L. ( A. hierochuntica), a folk medicinal plant, was evaluated for mutagenic potential via in vitro and in vivo assays. The in vitro assay was conducted according to modified Ames test, while the in vivo study was performed according to Organisation for Economic Co-operation and Development guideline for mammalian erythrocyte micronucleus assay. Four groups ( n= 5 males and 5 females per group) Sprague Dawley rats were randomly chosen as the negative control, positive control (received a single intramuscular injection of cyclophosphamide 50 mg/kg), 1000 and, 2000 mg/kg A. hierochuntica aqueous extracts. All groups except the positive control were treated orally for three days. Findings of the in vitro assay showed mutagenic potential of AHAE at 0.04 and 0.2 mg/ml. However, no mutagenic effect was demonstrated in the in vivo study up to 2000 mg/kg. No significant reduction in the polychromatic and normochromatic erythrocytes ratio was noted in any of the groups. Meanwhile, high micronucleated polychromatic erythrocytes frequency was seen in cyclophosphamide-treated group only. These findings could perhaps be due to insufficient dosage of A. hierochuntica aqueous extracts to cause genetic damage on the bone marrow target cells. Further acute and chronic in vivo toxicity studies may be required to draw pertinent conclusion on the safety aspect of A. hierochuntica aqueous extracts consumption. Impact statement In this paper, we report on the mutagenicity evaluation of Anastatica hierochuntica aqueous extract. This is a significant research in view of the popularity of this herb consumption by the people across the globe despite of limited scientific evidence on its toxicity potential. This study is intended to encourage more extensive related research in order to provide sufficient evidence and guidance for determining its safe dosage.

scholarly journals Assessment of the Mutagenic Activity of Extracts of Brazilian Propolis in Topical Pharmaceutical Formulations on Mammalian CellsIn VitroandIn Vivo

2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Juliana Marques Senedese ◽  
Aline Rafaela Rodrigues ◽  
Michelle Andrade Furtado ◽  
Viviane Dias Faustino ◽  
Andresa A. Berretta ◽  
...  
Keyword(s):  
Chromosomal Aberrations ◽  
Mutagenic Activity ◽  
Biological Activities ◽  
Antioxidant Properties ◽  
Test System ◽  
Negative Control ◽  
Continuous Treatment ◽  
Mutagenic Potential ◽  
Topical Formulations

Propolis possesses various biological activities such as antibacterial, antifungal, anti-inflammatory, anesthetic and antioxidant properties. A topically applied product based on Brazilian green propolis was developed for the treatment of burns. For such substance to be used more safely in future clinical applications, the present study evaluated the mutagenic potential of topical formulations supplemented with green propolis extract (1.2, 2.4 and 3.6%) based on the analysis of chromosomal aberrations and of micronuclei. In thein vitrostudies, 3-h pulse (G1phase of the cell cycle) and continuous (20 h) treatments were performed. In thein vivoassessment, the animals were injured on the back and then submitted to acute (24 h), subacute (7 days) and subchronic (30 days) treatments consisting of daily dermal applications of gels containing different concentrations of propolis. Similar frequencies of chromosomal aberrations were observed for cultures submitted to 3-h pulse and continuous treatment with gels containing different propolis concentrations and cultures not submitted to any treatment. However, in the continuous treatment cultures treated with the 3.6% propolis gel presented significantly lower mitotic indices than the negative control. No statistically significant differences in the frequencies of micronuclei were observed between animals treated with gels containing different concentrations of propolis and the negative control for the three treatment times. Under the present conditions, topical formulations containing different concentrations of green propolis used for the treatment of burns showed no mutagenic effect in either test system, but 3.6% propolis gel was found to be cytotoxic in thein vitrotest.

Connecting Across Competencies: Leveraging Best Practices for Processing

2021 ◽  
Vol 55 (s3) ◽  
pp. 6-11
Author(s):  
Terra A. Kremer ◽  
Kaumudi Kulkarni ◽  
Christopher Ratanski ◽  
Lorraine Floyd ◽  
Christopher Anderson
Keyword(s):  
Best Practices ◽  
Medical Devices ◽  
Technical Information ◽  
Test Sample ◽  
Positive Control ◽  
Standard Test ◽  
Test Method ◽  
Cleaning Validation ◽  
Validation Parameters ◽  
Method Suitability

Abstract The AAMI working group ST/WG 93 is finalizing a standard (AAMI ST98) for the cleaning validation of reusable medical devices based on guidance from the technical information report AAMI TIR30:2011/(R)2016. A number of analytical best practices are being considered for this new standard. Test method suitability for processing cleaning validations historically has been established using one positive control and performing an extraction efficiency. The new cleaning validation standard is proposed to require a change from only one replicate test sample to three when performing method suitability. This change will affect manufacturers; therefore, the value of and consideration for performing these additional replicates requires explanation. This article discusses how variation of validation parameters can affect the accuracy and precision during method suitability testing. Multiple replicates are needed to understand the variability of method extraction and impact on cleaning validations of reusable medical devices.

Comparison of Three Methods for Determination of /V-Nitrosopyrrolidine in Fried Dry-Cured and Pump-Cured Bacon

1988 ◽  
Vol 71 (3) ◽  
pp. 504-508
Author(s):  
Anthony J Malanoski ◽  
Wertice J Smith ◽  
Thomas Phillipo
Keyword(s):  
Low Temperature ◽  
Thermal Energy ◽  
Validation Studies ◽  
Vacuum Distillation ◽  
Mineral Oil ◽  
Energy Analyzer ◽  
Coefficients Of Variation ◽  
The Individual

Abstract Three methods, the mineral oil distillation (MOD), the dry column (DC), and a low temperature vacuum distillation (LTVD), for the determination of iV-nitrosopyrrolidine in dry-cured and pump-cured bacon were compared. Each method uses the thermal energy analyzer for the determinative step. The coefficients of variation for repeatability were 10.3% (MOD), 7.2% (DC), and 9.1% (LTVD) for the dry-cured bacon study and 8.7% (MOD), 8.5% (DC), and 7.1% (LTVD) for the pump-cured bacon study. The pooled coefficients of variation for between-method reproducibility were 11.8% for the drycured bacon and 10.8% for the pump-cured bacon. The pooled coefficients of variation for repeatability were 9.0% for the dry-cured bacon and 8.2% for the pump-cured bacon. These values compare favorably with the values from previous collaborative or validation studies of the individual methods, and the methods can be considered to be equivalent

scholarly journals Effect of Test Method and Needle Plane Configuration on Partial Discharge Inception Voltage Measurement of Mineral Oil based on Weibull Analysis

2013 ◽  
Vol 11 ◽  
pp. 411-418 ◽  
Author(s):  
T.F. Sipahutar ◽  
A.A. Kemma ◽  
N. Pattanadech ◽  
F. Pratomosiwi ◽  
Suwarno ◽  
...  
Keyword(s):  
Partial Discharge ◽  
Mineral Oil ◽  
Test Method ◽  
Weibull Analysis ◽  
Voltage Measurement ◽  
Inception Voltage

Studies of the Toxicological Potential of Tripeptides (L-Valyl-L-prolyl-L-proline and L-lsoleucyl-L-prolyl-L-proline): VII. Micronucleus Test of Tripeptides-Containing Casein Hydrolysate and Lactobacillus helveticus-fermented Milk Powders in Rats and Mice

2005 ◽  
Vol 24 (4_suppl) ◽  
pp. 91-96 ◽  
Author(s):  
Keiichi Matsuura ◽  
John H. Mennear ◽  
Masafumi Maeno ◽  
Bruce K. Bernard
Keyword(s):  
Bone Marrow Cells ◽  
Micronucleus Test ◽  
Casein Hydrolysate ◽  
Fermented Milk ◽  
Positive Control ◽  
Lactobacillus Helveticus ◽  
Oral Gavage ◽  
Mutagenic Potential ◽  
Polychromatic Erythrocytes ◽  
Rats And Mice

The objective of these in vivo experiments was to assess the mutagenic potential of tripeptides as reflected by the ability of the test compound to induce the formation of micronuclei in mouse polychromatic erythrocytes. The test agents used in these experiments were (1) powdered Aspergillus oryzae protease casein hydrolysate (CH) and (2) powdered Lactobacillus helveticus-fermented milk (FM). Both test agents contain two tripeptides, L-valyl-L-prolyl-L-proline (VPP) and L-isoleucyl-L-prolyl-L-proline (IPP). Male Sprague-Dawley rats (five per group) were administered doses of 0, 500, 1000, or 2000 mg (0, 3, 6, or 12 mg VPP plus IPP)/kg body weight (BW)/day CH by oral gavage for 2 days. Male CD-I mice (six per group) received a single oral gavage dose of 0, 500, 1000, or 2000 mg (0, 0.8, 1.6 or 3.3 mg VPP plus IPP)/kg BW of FM. Positive-control agents were cyclophosphamide (10 mg/kg, intraperitoneal [i.p.]) in rats and mitocycin C (2 mg/kg, i.p.) in mice. Twenty-four hours after the second dose of CH, or the dose of cyclophosphamide to rats, or FM or mitocycin C to mice, bone marrow cells were fixed and examined for the presence of polychromatic erythrocytes (PCEs) and the presence or absence of mi-cronucleated PCEs (MNPCEs). Administration of CH to rats and FM to mice produced neither changes in body weights nor signs of systemic toxicity. Similarly, neither CH nor FM caused statistically significant variations in the incidences of either PCEs or MNPCEs. Both positive-control agents caused unequivocal increases in the incidence of MNPCEs and cyclophosphamide significantly reduced the percent of rat erythrocytes appearing as PCEs. The results of these micronucleus assays conducted with either powdered CH or FM in rats and mice, respectively, show that neither form of the tripeptides possesses the potential to induce micronuclei formation in these rodent species.

Sign in / Sign up

Export Citation Format

Share Document