Toxicity carcinogenicity tests. Medical search. Frequent questions

These sources included standard toxicology reference texts, genotoxicity and subchronic toxicity assay results for each chemical, as well as Salmonella mutagenicity and carcinogenicity data for close structural analogues. (nih.gov)
Most genotoxicity tests have been negative. (cdc.gov)
Brivaracetam has been tested in a comprehensive safety pharmacology, toxicology, developmental toxicology, and genotoxicity program. (nih.gov)
It is noted that a relatively pure (>95% polysaccharide) non- acetylated gum product was used in the acute toxicity studies, the 13-week oral rat study and the genotoxicity studies. (inchem.org)
With regard to genotoxicity and carcinogenicity the properties of sodium percarbonate also resemble those of hydrogen peroxide and it can be concluded that there is no concern for humans with regard to a possible genotoxicity or carcinogenicity of sodium percarbonate. (heraproject.com)
guidelines for non-clinical safety studies, including testing for genotoxicity, carcinogenicity, and reproductive toxicity. (telugugmp.com)

California has Proposition 65 , otherwise known as the Safe Drinking Water and Toxic Enforcement Act of 1986, which contains a list of banned chemicals "known to the state to cause cancer or reproductive toxicity. (medscape.com)
The Environmental Working Group ( EWG ) rates the safety of ingredients based on carcinogenicity, developmental and reproductive toxicity, allergenicity, and immunotoxicity. (medscape.com)
Many of the standards combine all of the following into the "clean" designation: nontoxic to the environment (both the production process and the resulting ingredient), nontoxic to marine life and coral, cruelty-free (not tested on animals), hypoallergenic, lacking in known health risks (carcinogenicity, reproductive toxicity), vegan, and gluten free. (medscape.com)
This discussion will not consider environmental effects, reproductive toxicity (some ingredients may decrease fertility, which is beyond the scope of this article), ingredient sources, and sustainability, animal testing, or human rights violations during production. (medscape.com)
Therefore, neither sodium percarbonate itself nor hydrogen peroxide or carbonate will reach the organs or the foetus and there is no risk for systemic, developmental or reproductive toxicity. (heraproject.com)

Prediction of rodent carcinogenicity using the DEREK system for 30 chemicals currently being tested by the National Toxicology Program. (nih.gov)
The DEREK system has been used to predict the carcinogenicity in rodents of the 30 chemicals in the second National Toxicology Program (NTP) carcinogenicity prediction exercise. (nih.gov)
Together with the substantial historical database regarding basic developmental biology, toxicology, and gene transfer, the rich foundation of molecular genetic and genomic data makes zebrafish a powerful model system for clarifying mechanisms in toxicity. (nih.gov)
Research conducted by the National Toxicology Program (NTP), centered at the NIEHS, focuses on evaluation of environmental/industrial agents for their toxic effects using a broad array of assays and test systems, and generates data to strengthen the scientific foundation for risk assessment. (nih.gov)
As a study scientist, Ryan collaborates with members of the Toxicology Branch as well as various intramural and extramural partners to investigate the safety of chemical agents nominated to the NTP toxicity testing program. (nih.gov)
the memorandum contains summaries of toxicology information, including the results of previous toxicity studies and information from relevant scientific literature. (fda.gov)
Toxicology and carcinogenicity studies were conducted in F344/N rats and B6C3F1 mice. (nih.gov)
In September 2012, the research team led by Gilles-Eric Séralini at the University of Caen published the findings of their feeding trial on rats to test for toxicity of Monsanto's genetically modified (GM) maize NK603 and/or Roundup herbicide in the online edition of Food and Chemical Toxicology [1]. (i-sis.org.uk)
Pharma veteran Brian Berridge is positioning the US National Toxicology Program on the front lines of rapidly advancing technologies for testing chemical hazards. (acs.org)
After more than 40 years of evaluating the hazards of chemicals by testing animals to extrapolate human health effects, the US National Toxicology Program is shifting gears. (acs.org)

In a chronic/carcinogenicity study, rats exposed to NVP by inhalation showed dose-related increased incidences of hepatocellular carcinomas and nasal cavity adenomas and adenocarcinomas as well as increased incidences of squamous carcinomas of the larynx at the highest dose tested. (gc.ca)
This ADI was established by the EFSA FEEDAP Panel (2014b) [2] and was based on a benchmark dose (BMD) lower confidence limit for a 10 % extra risk (BMDL 10 ) calculated for the liver hypertrophy observed in female rats in a chronic toxicity/carcinogenicity study with synthetic astaxanthin and by applying an uncertainty factor of 100 to the BMDL 10 of 3.4 mg/kg bw. (europa.eu)

The most extensive section reviews the large number of studies of toxicological effects conducted in laboratory mammals and in vitro test systems. (who.int)
Datasets evaluated by the ICH S1 expert working group (S1 EWG) suggest that knowledge of pharmacologic targets and pathways together with toxicological and other data can, in certain cases, provide sufficient information to anticipate the outcome of 2-yr rat carcinogenicity studies and their potential value in predicting the risk of human carcinogenicity of a given pharmaceutical. (canada.ca)
2.2 Toxicological studies 2.2.1 Acute toxicity LD 50 Species Sex Route (mg/kg b.w. (inchem.org)
They include forensic toxicological analysis, workplace drug testing, clinical analysis or hospital drug testing. (toxicologyconferences.com)
With its world-class ultramodern facilities comprising of a custom designed experimental animal house for small animals, well equipped pathology, microbiology & analytical laboratories all under one roof, TOXINDIA has been offering high quality toxicological testing services for the last 15 years. (toxindia.in)

These findings suggest quantitative considerations for building scientific confidence in NAM-based systemic toxicity predictions. (nih.gov)
Systemic toxicity testing forms the cornerstone for the safety evaluation of substances. (altex.org)
The latter holds especially true in the context of the scheduled 2013 marketing ban on cosmetic ingredients tested for systemic toxicity. (altex.org)
2011), the present report proposes a roadmap for how to overcome the acknowledged scientific gaps for the full replacement of systemic toxicity testing using animals. (altex.org)

During the discussion in that period the relevance of the life-time carcinogenicity studies in rats and mice was already highly debated, but in the absence of an alternative the outcome of the negotiations did not really change the basic strategy of testing pharmaceuticals for human use in two rodent species. (canada.ca)
2010) with the outcome that a negative histopathology result in rats (for example [e.g.], no evidence of hyperplasia in any organ) might be predictive for the absence of tumors in a 2-yr rat carcinogenicity study. (canada.ca)
In this study statistically significant increased incidences of hepatocellular vacuolation, hepatocellular hypertrophy and multinuclear hepatocytes were observed in female rats at all tested dose levels (i.e. 40, 200 and 1,000 mg synthetic astaxanthin per kg bw). (europa.eu)
An EPA OPPTS 870.430 study was conducted using phthalic anhydride, an analogue substance for PMDA, by administering the test chemical in feed to F344 rats and B6C3F1 mice. (europa.eu)
All surviving rats were killed at the end of the period of administration of the test chemical. (europa.eu)
mean body weights of the low-dose male rats and of both the low- and high-dose female rats were essentially unaffected by administration of the test chemical. (europa.eu)
Survivals of the rats and mice were not affected by administration of the test chemical. (europa.eu)
No tumors occurred in the rats or mice of either sex at incidences that could be clearly related to the administration of the test chemical. (europa.eu)
So the team decided to run their own experiment, using an unusually large number of animals and over a period of about two years, roughly the life expectancy of the rats, rather than the usual 90 days required in toxicity trials including Monsanto's. (i-sis.org.uk)
Repeated-dose toxicity study by oral route has been performed on synthetic amorphous silica (SAS) as a read-across substance representing a worst-case scenario, according to a method similar to 453, on rats which is the preferred species for this study. (europa.eu)
In a rat carcinogenicity study to determine the human relevance of mesotheliomas Wistar Han rats were exposed to 0, 0.5, 1.5, or 3.0 mg acrylamide/kg body weight/day in drinking water starting at gestation day 6. (gpstoxpath.com)

Embryo-fetal Toxicity: May cause fetal harm. (nih.gov)
Embryo-fetal Toxicity: Bortezomib Injection can cause fetal harm. (nih.gov)

Computerized SAR analyses-ultimately ideal in terms of their relative economy and rapidity-have considerable potential but have been restricted largely to the prediction of mutagenicity and carcinogenicity of chemicals in structurally related classes. (nationalacademies.org)
More than 180 in vitro and in vivo STTs for predicting mutagenicity and carcinogenicity have been developed, but few have been evaluated on a sufficiently broad spectrum of carcinogens and noncarcinogens to define their predictive value, and no single SST or combination of SSTs has been found to be adequately predictive of carcinogenicity. (nationalacademies.org)

However, certain tests have indicated that DEHP may affect the genome in-vitro. (cdc.gov)
Triethanolamine was not mutagenic in any of the in vitro or in vivo tests. (nih.gov)
These in vitro tests were all conducted with and without S9 metabolic activation. (nih.gov)
The existing methods for predicting long-term chemical toxicity-for example, analysis of structure-activity relationships (SAP,) and other correlational techniques, in vitro and in vivo short-term tests (STTs), and longer-term animal bioassays-all have valid, if different, uses at present and promise to become increasingly effective in the future, given appropriate research for their further development, validation, and integration. (nationalacademies.org)

The authors test for long-term toxicity of Roundup Herbicide and Roundup-tolerant GM maize. (hpathy.com)
This report summarize a workshop held in Washington, D.C., on December 13-15, 1989, on research to improve the methodology for predicting the long-term toxicity of chemicals. (nationalacademies.org)
Developing improved methods for predicting the long-term toxicity of chemicals will depend on improving our understanding of the underlying science and on effective coordination and integration of the relevant clinical, epidemiological, and laboratory approaches. (nationalacademies.org)

DEHP was carcinogenic and teratogenic in tests in rodents. (cdc.gov)
Laboratory studies have described the carcinogenicity of fumonisin B1 (FB1) in rodents and epidemiological evidence suggests an association between FB1 (a mycotoxin produced by Fusarium moniliforme) and cancer in humans. (nih.gov)
An understanding of the mechanism of toxicity/carcinogenicity will improve the ability to extrapolate from data collected in rodents to humans. (nih.gov)

None of the protocol variables such as test type, skin patch size, sample size, or dose applied were associated with high or low variability. (nih.gov)
As it is the lowest actual dose received, the NOAEL for repeated dose toxicity by oral route has been determined to be 1600 mg/kg bw/day. (europa.eu)
The preclinical toxicity testing on various biological systems reveals the species-, organ- and dose- specific toxic effects of an investigational product. (toxicologyconferences.com)
Other tests are more general in nature, ranging from acute (single-exposure) studies to repeat dose (multiple-exposure) studies, in which animals are administered daily doses of a test substances. (toxicologyconferences.com)

Scientists with CPSC , FDA , and NIEHS and collaborators compiled such a data set for human skin sensitization potential by collecting data from the scientific literature for human predictive patch tests that used the human maximization or human repeated insult patch test protocols. (nih.gov)

Though the petitioners conclude in general that no major physiological changes is attributable to the consumption of the GMO in subchronic toxicity studies [ 2 , 3 , 4 , 5 ], significant disturbances have been found and may be interpreted differently [ 6 , 7 ]. (hpathy.com)

A change to the current International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) S1 guidance document on rodent carcinogenicity testing is being considered. (canada.ca)

Because of this chemical's environmental persistence and toxicity to certain birds and crustaceans, use of DDT was effectively terminated ca. 1964. (msu.edu)
As manufacturers began to learn more about the chemical's toxicity and carcinogenicity, it quickly ran out of favor as safer alternative methods emerged. (hubbardhall.com)

Most of the toxicity tests examine specific types of adverse effects, known as endpoints, such as eye irritation or cancer. (toxicologyconferences.com)

Her primary responsibilities are to design and coordinate studies to evaluate the potential toxicity and carcinogenicity of various agents. (nih.gov)
Submitted CADs will be compared to the outcome of the 2-yr rat carcinogenicity studies to evaluate the accuracy of the predictions to the actual experimental results. (canada.ca)

As NVP was classified on the basis of carcinogenicity by other national and international agencies, carcinogenicity was a key focus for this screening assessment. (gc.ca)
Thus, research on the mechanisms of toxicity for these DBPs will improve the use of the NTP study data for risk assessment by policy makers. (nih.gov)
The goal of this potential change is to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals, and to define conditions under which 2-yr rat carcinogenicity studies add value to that assessment. (canada.ca)
It is envisioned that Sponsors of such pharmaceuticals would provide Drug Regulatory Agencies (DRAs) a Carcinogenicity Assessment Document (CAD) which could justify a 'waiver request' that seeks to omit the conduct of 2-yr rat carcinogenicity studies. (canada.ca)
The CAD would address the overall carcinogenic risk of the investigational drug as predicted by the endpoints discussed in this document and a rationale for why the conduct of 2-yr rat carcinogenicity studies would or would not add value to that assessment. (canada.ca)

This section on pathology considerations in toxicity studies describes the review process for pathology data, identifies common problems reviewers encounter in reviewing such data, and presents general guidelines for reporting pathology data. (fda.gov)

Reach emphasises general toxicity and carcinogenicity, at the expense of neurotoxicity', he said. (chemistryworld.com)
In practice it would be hard to define a test for neurotoxicity acceptable to industry that would also pick up long-term problems such as those caused by lead. (chemistryworld.com)

Data on carcinogenicity were judged inadequate. (who.int)
Because humans are the primary subject of interest for regulatory safety testing, it is advantageous to have human reference data available for evaluation of NAMs for assessing chemical safety. (nih.gov)
The data collection identified 2,255 tests that were deemed to be sufficiently reliable for the analysis, including reports for 232 substances with at least two test results. (nih.gov)
In presenting tables of summary data that reference statistical tests of hypotheses, a statement should identify the null and alternative hypotheses, the statistical test, the sampling distribution of the test statistic under the null hypothesis, the value of the test statistic, the degrees of freedom of the test statistic (when appropriate), the p-value, and whether the test is one or two tailed. (fda.gov)
At that time, data were insufficient to assess the efficacy of ZDV as a prophylactic agent in humans or the toxicity of this drug in persons not infected with HIV. (cdc.gov)
Séralini and his colleagues had previously found evidence for toxicity of GM feed in data from Monsanto's own experiments, which they had obtained through a Freedom of Information demand [2]. (i-sis.org.uk)
A toxicity test, by extension, is designed to generate data concerning the adverse effects of a substance on human or animal health, or the environment. (toxicologyconferences.com)
The available data show that the observed aquatic toxicity of sodium percarbonate can be explained by the formation of hydrogen peroxide. (heraproject.com)
The existing animal data on acute toxicity show that sodium percarbonate has a local effect. (heraproject.com)

Consideration of this information is hypothesized to provide sufficient information to conclude that a given pharmaceutical in certain cases presents a negligible risk or, conversely, a likely risk of human carcinogenicity without conducting a 2-yr rat carcinogenicity study. (canada.ca)
FDA emphasizes that communication between statisticians and the scientists conducting a particular toxicity study can help ensure that the statistics used are relevant to the biology of the toxicity test. (fda.gov)
Thus, it was not designed as a carcinogenicity study. (hpathy.com)
Study was conducted using a method equivalent to OECD Testing Guideline 453 and meets acceptable scientific standards. (europa.eu)

This guideline highlights factors that are of primary importance in assessing the validity of evidence from toxicity studies. (fda.gov)

at first, the toxicity was only recognised at higher doses in adults. (chemistryworld.com)
Groups of 50 mice of each sex were administered the test chemical at one of two doses, initially either 25,000 or 50,000 ppm, for 32 weeks. (europa.eu)
Administration of the test chemical at the lowered doses was continued for 72 weeks. (europa.eu)
Uncertainty The toxicity of drugs at high doses may be inconsistent with that of low doses. (medicilon.com)

Acute ecotoxicity tests with fish and water fleas revealed LC50 values of 71 and 4.9 mg/l. (heraproject.com)

The substance did not meet the ecological categorization criteria for persistence, bioaccumulation potential or inherent toxicity to aquatic organisms. (gc.ca)

DEREK is a knowledge-based expert system for the qualitative prediction of toxicity. (nih.gov)

However, it is doubtful that industries could afford to rigorously test their chemicals for neurotoxic effects, said Mark Selby, a chemicals legislation consultant for Denehurst Chemical Safety, Burley. (chemistryworld.com)
By using bench tests to help determine the best chemicals for the wastewater system, you can eliminate weeks of trial and error on a large scale. (hubbardhall.com)
Pressures to move from traditional animal models to novel technologies arise from various concerns, including: the need to evaluate large numbers of previously untested chemicals and new products (such as nanoparticles or cell therapies), the limited predictivity of traditional tests for human health effects, duration and costs of current approaches, and animal welfare considerations. (altex.org)

Sodium has a low toxicity and the emitted amount of sodium is relatively low compared to background concentrations and therefore the emitted amount of sodium will not have an effect on the aquatic organisms of the receiving water. (heraproject.com)

Testing: Before initiation and during treatment with TEMBEXA perform hepatic laboratory testing and pregnancy testing. (nih.gov)
Hepatic Toxicity: Monitor hepatic enzymes during treatment. (nih.gov)

This RFA, Carcinogenicity of Drinking Water Disinfection By-Products, is related to the priority area of environmental health, specifically the Section 11.9, People Receiving Safe Drinking Water. (nih.gov)

Paul Whitehead, chairman of the RSC's Environment, Health and Safety Committee, said that although there were no specific requirements for neurological testing under Reach, protocols for testing were available if required. (chemistryworld.com)

The strategy of testing for carcinogenic potential was the first safety topic of ICH when this process started. (canada.ca)
To ensure the validity of safety assessments of a food ingredient obtained from well-conducted toxicity studies, statistical expertise should be used routinely in the planning, design, execution, analysis, and interpretation of results. (fda.gov)
Drug safety evaluation is to clarify the toxicity and potential hazards of drugs through animal tests and observations of the population to determine whether they can enter the market or clarify the safe use conditions to minimize their harmful effects and protect human health. (medicilon.com)
Support human clinical trials and guide the design of clinical trials in each phase (selection of test population, dosage, dosage regimen, and selection of indicators for monitoring drug safety and efficacy) 2. (medicilon.com)

Salicylazosulfapyridine was nominated for toxicity and carcinogenicity testing by the National Cancer Institute on the basis of its widespread use in humans and because it is a representative chemical from a class of aryl sulfonamides. (nih.gov)

It is of low acute toxicity, target organ for toxic effects is the hepatobiliary tract. (nih.gov)

A prospective evaluation period is sought wherein Sponsors will be strongly encouraged to submit CADs to DRAs for all investigational pharmaceuticals with ongoing or planned 2-yr rat carcinogenicity studies. (canada.ca)
During this prospective evaluation period the waiver requests are not to be granted but are intended solely for gathering experience and hypothesis testing (see below, however, for existing waiver capability under current S1A Guidance). (canada.ca)
Experience from this prospective evaluation period is considered critical to informing the S1 EWG's efforts in revising the current paradigm of assessing the carcinogenicity of small molecules as described in ICH S1 guidance. (canada.ca)

Hazardous substances--toxicity. (who.int)

There is an ongoing international debate as to the necessary length of mammalian toxicity studies, including metabolic analyses, in relation to the consumption of genetically modified (GM) plants [ 1 ]. (hpathy.com)

The purpose of this bulletin is to disseminate recent information about the potential carcinogenicity of acetaldehyde and malonaldehyde. (cdc.gov)
Carcinogenicity: TEMBEXA should be considered a potential human carcinogen. (nih.gov)

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Phenomena and Processes1

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Genotoxicity6

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Mutagenicity and carcinogenicity2

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