Carcinogenicity tests. Medical search. Frequent questions

A dataset of 805 substances was obtained after a preliminary screening of findings of rodent carcinogenicity for 1,481 chemicals accessible via Distributed Structure-Searchable Toxicity (DSSTox) Public Database Network originated from the Lois Gold Carcinogenic Potency Database (CPDB). (nih.gov)
It is anticipated that this investigator-initiated research will complement the NTP contract toxicity/carcinogenicity studies of DBPs by providing additional information on their mechanism of action. (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)
In this webinar, you will hear directly from experts on how they use machine learning to reveal molecular mechanisms, simulate testing, estimate toxicity values, and harness available information. (pcrm.org)
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)
The experiment was designed to test for toxicity, and for that the recommended group size is 10. (i-sis.org.uk)
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)
Her primary responsibilities are to design and coordinate studies to evaluate the potential toxicity and carcinogenicity of various agents. (nih.gov)
They are currently considering publishing a series of protocols for genetic toxicity testing of products containing nanomaterials. (hesiglobal.org)
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)
Reach emphasises general toxicity and carcinogenicity, at the expense of neurotoxicity', he said. (chemistryworld.com)

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)
For guidance on many types of safety testing, implant makers turn to ISO 10993, which contains a series of assays for evaluating the biocompatibility of a medical device. (mddionline.com)
Genotoxicity tests comprise in vitro and in vivo assays to assess the effects on DNA and chromosomal structure and/or function. (nationalacademies.org)
In evaluating the applicability of the results of these tests to human risk from fluoride ingestion, some of the key parameters are the concentrations used in the assays compared with physiologic concentrations, the form and vehicle for fluoride exposure in the assay, and existing data on overall applicability of the various assays to risk in humans. (nationalacademies.org)
Results of mouse skin painting tests and initiation/promotion assays, together with modified Ames tests, and chemical (PAH) analysis indicate that Heavy Fuel Oil Components, particularly those containing cracked material, are carcinogenic. (europa.eu)
Therefore relevant in vitro mechanisms and assays are described and tentatively organized in levels of information, indicating both a possible structure of the future IATA for NGTxC and associated OECD Test Guideline development priorities. (norecopa.no)
HESI's achievements include the dataset to guide the selection of appropriate supporting assays for carcinogenicity testing, a new testing framework for agricultural chemicals with enhanced efficacy, predictivity, and reduced animal usage, novel biomarkers of nephrotoxicity which provide data on the location of timing of drug effects in the kidney allowing for enhanced drug development, etc. (biomedcentral.com)

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 is an integrative approach that provides specific weight of evidence (WoE) criteria that inform whether a 2-year rat study is likely to add value to a human carcinogenicity risk assessment. (nih.gov)
Existing approaches for cancer hazard assessment rely extensively on data from whole animal tests that take years to complete and cost millions of dollars. (nih.gov)
Current approaches to environmental hazard assessment do not include specific tests of cardiovascular bioactivity and hazards despite growing evidence that environmental exposures contribute to the onset, risk, or progression of chronic cardiovascular disease. (nih.gov)
So why is the transition out of animal testing and into a NAM-based approach to Chemical Safety Assessment predicted to take so long by so many commentators? (pcrm.org)
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)
Human embryonic stem cell derived hepatocyte-like cells as a tool for in vitro hazard assessment of chemical carcinogenicity. (mpg.de)
The work group has evaluated the current testing paradigm for genotoxicity assessment of nanomaterials and is publishing the findings and recommendations for modifying the tests as needed. (hesiglobal.org)
The development of an Integrated Approach to Testing and Assessment (IATA) of NGTxC could assist regulatory decision makers. (norecopa.no)

If any of the in vivo genotoxicity tests are positive, a lifetime rodent cancer bioassay may be requested, which allows the detection of non-genotoxic carcinogens (NGTxC). (norecopa.no)
In contrast to genotoxic carcinogens NGTxCact through a large variety of specific mechanisms, and a panel of tests covering multiple biological traits will be needed. (norecopa.no)

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)
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)
1991) reviewed the results of various genotoxicity tests in comparison with animal carcinogenicity studies, and found that in vitro cytogenetic tests, particularly sister-chromatid exchange tests (SCEs), were more predictive of carcinogenicity than the Salmonella reverse mutation assay. (nationalacademies.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)
Paracetamol was tested for carcinogenicity by oral administration in mice and rats. (inchem.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)
Group 1 consisted of fifty rats per sex per dose for carcinogenicity observations. (europa.eu)

The Carcinogenome Project: In Vitro Gene Expression Profiling of Chemical Perturbations to Predict Long-Term Carcinogenicity. (nih.gov)
When the in vitro genotoxicity battery is negative, usually no further carcinogenicity testing is requested. (norecopa.no)

1987) concluded that the Salmonella reverse mutation assay was the best short-term genotoxicity assay available for predicting carcinogenicity in mammals. (nationalacademies.org)
On 30 June 22, the Organisation for Economic Cooperation and Development (OECD) published Test #470: Mammalian Erythrocyte Pig-a Gene Mutation Assay , a Test Guideline (TG) that describes an in vivo gene mutation assay that can be combined with other genetic and general toxicology tests to promote the efficient use of animal resources. (hesiglobal.org)

The draft guidance expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals. (nih.gov)

In an October 2021 Federal Register notice ( 86 FR 54982 ), FDA announced draft guidance for industry, " S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals . (nih.gov)
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)
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)
Genotoxicity and carcinogenicity testing of pharmaceuticals: correlations between induction of DNA lesions and carcinogenic activity. (nih.gov)
This Addendum is to be used in close conjunction with the ICH guidances for industry S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals (March 1996), S1B Testing for Carcinogenicity of Pharmaceuticals (July 1997), and S1C(R2) Dose Selection for Carcinogenicity Studies (September 2008). (nih.gov)
This Addendum applies to all pharmaceuticals that need carcinogenicity testing as described in ICH S1A. (nih.gov)
Application of this integrative approach reduces the use of animals in accordance with the 3R (reduce/refine/replace) principles and shifts resources to focus on generating more scientific mechanism-based carcinogenicity assessments, while continuing to promote safe and ethical development of new pharmaceuticals. (nih.gov)

We believe that CP ANN method is a good in silico approach for modeling and predicting rodent carcinogenicity for non-congeneric chemicals and may find application for other toxicological endpoints. (nih.gov)

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)

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)

2017. A miRNA signature for an environmental heterocyclic amine defined by a multi-organ carcinogenicity bioassay in the rat. . (oregonstate.edu)
However, under most chemical regulations the cancer bioassay is rarely requested, specific requests to obtain information on non-genotoxic mechanisms of carcinogenicity are few, and there are no OECD approved screening methods. (norecopa.no)

Structural correlates of carcinogenesis and mutagenesis : a guide to testing priorities? (who.int)

The Department of Health and Human Services, the International Agency for Research on Cancer, and the Environmental Protection Agency (EPA) have not classified hexamethylene diisocyanate as to its human carcinogenicity. (cdc.gov)
Testing to see if something can cause cancer is often difficult. (cancer.org)
It isn't ethical to test a substance by exposing people to it and seeing if they get cancer from it. (cancer.org)
Tests on lab animals of Blue 1, Blue 2, Green 3, Red 40, Yellow 5, and Yellow 6 showed signs of causing cancer or suffered from serious flaws, said the consumer group. (commondreams.org)
In addition, according to the report, FDA tests show that the three most-widely used dyes, Red 40, Yellow 5, and Yellow 6, are tainted with low levels of cancer-causing compounds, including benzidine and 4-aminobiphenyl in Yellow 5. (commondreams.org)
Some dyes have caused cancers in animals, contain cancer-causing contaminants, or have been inadequately tested for cancer or other problems. (commondreams.org)
In interpreting the experimental studies and the consistency among disparate tests and systems, factors to be considered include the chemical form, concentrations, duration of exposure or application, vehicle or route of exposure, presence or absence of dose response, and information that each study provides about the potential stage of cancer development at which the chemical might operate. (nationalacademies.org)
Regarding carcinogenicity, the HCS requires any chemical which has been designated a carcinogen (or potential carcinogen) by the International Agency for Research on Cancer (IARC) , the National Toxicology Program (NTP) , or is regulated as a carcinogen by OSHA to be listed as a carcinogen on the MSDS. (ilpi.com)

The new European chemicals regulation Registration, Evaluation, Authorization and Restriction of Chemicals entered into force in June 2007 and accelerated the development of quantitative structure-activity relationship (QSAR) models for a variety of endpoints, including carcinogenicity. (nih.gov)
The high correlation between the Umu Chromotest and traditional Ames test for mutagenicity supports it as a reasonable alternative for early-stage testing of the thousands of new pharmaceutical, agricultural and industrial chemicals synthesized every year. (wikipedia.org)
Most large chemical manufacturers have the ability to screen 100 or more synthetic chemicals per year with the traditional Ames test, which requires the use of several Salmonella strains. (wikipedia.org)
The umu test, using only a single Salmonella strain, could potentially test a greater range of new chemicals with the same resources. (wikipedia.org)
Other activities carried out by the IPCS include the development of know-how for coping with chemical accidents, coordination of laboratory testing and epidemiological studies, and promotion of research on the mechanisms of the biological action of chemicals. (inchem.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)
Although regulatory requirements for carcinogenicity testing of chemicals vary according to product sector and regulatory jurisdiction, the standard approach starts with a battery of genotoxicity tests. (norecopa.no)
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)

Most, if not all, vaccines have never been tested for carcinogenicity or mutagenicity. (hpathy.com)

Salmonella typhimurium TA 1535 [pSK 1002] bacteria are exposed to potentially genotoxic test compounds in a 96-well microplate. (wikipedia.org)

The HESI GTTC is pleased to share its newest publication, " Error-corrected next-generation sequencing to advance nonclinical genotoxicity and carcinogenicity testing ," published in Nature Reviews Drug Discovery . (hesiglobal.org)

Evaluation of the plausibility and potential for carcinogenicity is based on human epidemiologic studies, laboratory animal lifetime bioassays, shorter-term genotoxicity tests, metabolism and pharmacokinetic data, and mechanistic information. (nationalacademies.org)
The degree of consistency of genotoxicity tests with the epidemiologic studies and whole animal bioassays on these points was evaluated. (nationalacademies.org)

A decision tree-based integrated testing strategy for tailor-made carcinogenicity evaluation of test substances using genotoxicity test results and chemical spaces. (nih.gov)
However, this test only works if you were exposed to the chemical within the last 12 to 15 hours. (cdc.gov)
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)
Testing chemical carcinogenicity by using a transcriptomics HepaRG-based model. (mpg.de)
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)
The 17-member panel of scientists reviewed almost 1,000 peer-reviewed, published studies on the potential carcinogenicity of the chemical. (ewg.org)
The letter also clarifies criteria for "scientifically validated" chemical testing methods. (ehs.com)

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)
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)
But unlike other products, medical implants are also tested to see whether they can somehow cause harm during long-term residence in the human body. (mddionline.com)
Instead, scientists must use other types of tests, such as lab tests on cell cultures and animals, or epidemiology studies, which look at human populations. (cancer.org)
Regulatory Toxicology has reached a tipping point - animal tests are increasingly outmoded by New Approach Methodologies (NAMs) that offer the potential to improve human health and environmental protection. (pcrm.org)
The CDC regularly tests human biomonitoring samples for a number of contaminants and diseases. (ewg.org)

FDA's main concern is safety, so much of the testing done on new products seeks to evaluate potential risks. (mddionline.com)

Studies of carcinogenicity in animals almost do not support the risk for childhood leukemia [ 7 ]. (springer.com)

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)
The test substance elicited skin irritation that was similar in extent and incidence to that seen in the vehicle controls, with an increased incidence of malignant tumours with decreased latency present in the intermediate and high dose groups. (europa.eu)

CAS# 64741 -62 -4) was tested in a key non-guideline GLP-compliant lifetime mouse skin painting study (API, 1989a). (europa.eu)

N-vinyl compounds: studies on metabolism, genotoxicity, carcinogenicity. (nih.gov)
Dynamically monitoring cellular γ-H2AX reveals the potential of carcinogenicity evaluation for genotoxic compounds. (nih.gov)

Yellow 5 also caused mutations, an indication of possible carcinogenicity, in six of 11 tests. (commondreams.org)
Combined Targeted Re-Sequencing of Cytosine DNA Methylation and Mutations of DNA Repair Genes with Potential Use for PARP1 Inhibitor Sensitivity Testing. (mpg.de)

However, there are problems with these tests: antibodies can react with other substances that look like hexamethylene diisocyanate in your blood and indicate that you have been exposed to hexamethylene diisocyanate when you have not been. (cdc.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)

Quantitative sensory testing includes vibration threshold testing, thermal threshold testing, portable motor and sensory latency tests, and current perception threshold (CPT) testing. (medscape.com)
Laser evoked potential and Quantitative Sudomotor Axon Reflex Test (QSART) have been useful in research. (medscape.com)

Additionally it was aimed at developing alternative testing strategies to minimize animal testing. (europa.eu)
NLM developed ALTBIB to provide access to PubMed citations for users seeking information on alternatives to animal testing. (nih.gov)
With a strong drive to reduce animal testing and costs in mind, it is essential that proper and robust alternatives for animal testing (3Rs) methods for addressing non-genotoxic modes of action are developed and used. (norecopa.no)

A Group 3 listing indicates that diatomaceous earth is not classifiable as to its carcinogenicity to humans, since definitive conclusions cannot be drawn from the research conducted to date. (ilpi.com)

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)

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)

Results of search for 'su:{Carcinogenicity tests. (who.int)
However, the principle of "one positive study" applies here as well, and the results of any study conducted in accordance with scientific principles which shows statistical significance of carcinogenicity resulting from exposures to this product must be included for discussion on the MSDS. (ilpi.com)

The strategy of testing for carcinogenic potential was the first safety topic of ICH when this process started. (canada.ca)

In July 2020, EWG released an analysis of laboratory testing that shows glyphosate in more than 90 percent of non-organic hummus and chickpea samples. (ewg.org)

The vaccines themselves are not tested in the rigorous manner required of all other pharmaceutical drugs by the FDA, but are rushed through as therapeutic biological products. (hpathy.com)

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)

S. typhimurium bacteria in the exponential phase of growth are exposed for 2 hours to decreasing concentrations of test sample in triplicate, including positive and negative controls, as well as blanks. (wikipedia.org)
The pulverized food was then homogenously mixed with the appropriate concentrations of the test material and about 25% water was added before pelleting to ensure the necessary pellet quality. (europa.eu)

To satisfy government agencies and meet international requirements, implants undergo many different safety tests spanning a variety of technologies and requiring widely varying amounts of time and money. (mddionline.com)
the giving of multiple vaccines in the same doctor visit has never been tested for safety. (hpathy.com)

ALTBIB is the Bibliography on Alternatives to the Use of Live Vertebrates in Biomedical Research and Testing. (nih.gov)

The test solutions (50 uL) were applied twice weekly to an area of clipped skin on the dorsum, and the test included appropriate negative (sham, vehicle) and positive (0.01%, 0.05% benzo(a)pyrene) controls. (europa.eu)

To see why, we have to look carefully at how common statistical tests are carried out. (i-sis.org.uk)

Organisms1

Diseases1

Chemicals and Drugs3

Analytical, Diagnostic and Therapeutic Techniques and Equipment4

Disciplines and Occupations1

Toxicity11

Assays7

Assessment11

Carcinogens2

Predictive3

Rats4

Vitro2

Assay2

Small molecule pharmaceuticals1

Pharmaceuticals7

Rodent1

Revising the current paradigm1

Studies to evaluate1

Bioassay2

Carcinogenesis1

Cancer8

Chemicals8

Mutagenicity1

Salmonella1

Nonclinical1

Genotoxicity tests2

Chemical7

Human6

Evaluate1

Animals1

Dose2

Guideline1

Compounds2

Mutations2

Substances2

Quantitative2

Animal3

Humans1

Guidance1

Data1

Results2

Potential1

Laboratory1

Pharmaceutical1

Environmental1

Concentrations2

Safety2

Research1

0.051

Statistical tests1