Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Background to the ADI/TDI/PTWI.

J L Herrman1, M Younes

  • 1International Programme on Chemical Safety, World Health Organization, Geneva, Switzerland.

Regulatory Toxicology and Pharmacology : RTP
|December 22, 1999
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

STSM 2025 & 2nd African Medical Writing Congress.

La Tunisie medicale·2026
Same author

Applying the adverse outcome pathway concept for assessing non-monotonic dose responses: biphasic effect of bis(2-ethylhexyl) phthalate (DEHP) on testosterone levels.

Archives of toxicology·2022
Same author

The Lebanese left ventricular assist device experience, a success story despite the odds.

Journal of cardiothoracic surgery·2020
Same author

[Difficulty in diagnosis of a cardiogenic shock with thrombotic and sub-occluded LAD. A train can hide another one!]

Annales de cardiologie et d'angeiologie·2017
Same author

[Postoperative quality of life of patients with a bacterial necrotizing dermis-hypodermitis or necrotizing fasciitis, a ten-year study].

Annales de chirurgie plastique et esthetique·2016
Same author

p53 mutations cooperate with oncogenic Kras to promote adenocarcinoma from pancreatic ductal cells.

Oncogene·2015
Same journal

The NTP Chronic Inhalation Study Does Not Support an Inherent Lung Cancer Hazard of Talc: Implications of Lung Particle Overload and Maximum Tolerated Dose.

Regulatory toxicology and pharmacology : RTP·2026
Same journal

Consideration of Carcinogenicity and Mode of Action Information by an Independent Expert Panel to Support Derivation of No-Significant-Risk-Level Values for Vinyl Acetate Monomer.

Regulatory toxicology and pharmacology : RTP·2026
Same journal

Which carcinogenicity study should I use? Automated identification of reliable studies.

Regulatory toxicology and pharmacology : RTP·2026
Same journal

Adoption of artificial intelligence in drug review across the lifecycle: Transformation of regulatory decision-making.

Regulatory toxicology and pharmacology : RTP·2026
Same journal

Cardiovascular outcomes following intrauterine and lactational exposure to cyantraniliprole in male Wistar rats.

Regulatory toxicology and pharmacology : RTP·2026
Same journal

Pesticide residue and mycotoxin occurrence in apples and their impact on human health in Morocco.

Regulatory toxicology and pharmacology : RTP·2026
See all related articles

Regulatory bodies establish safe intake levels for toxic substances using safety factors, typically derived from no-observed-adverse-effect levels (NOAELs). These safety factors, often 100, account for variations in species and individuals to ensure consumer safety.

Area of Science:

  • Food Safety and Toxicology
  • Risk Assessment Methodologies
  • Chemical Regulation

Background:

  • International and national agencies use safety factor approaches to set acceptable intake levels for substances with toxicity thresholds.
  • Key terms include Acceptable Daily Intake (ADI), Reference Dose (RfD), and Tolerable Daily/Weekly Intake (TDI/PTWI).
  • The safety factor approach typically applies uncertainty factors to No-Observed-Adverse-Effect Levels (NOAELs) derived from toxicity studies.

Purpose of the Study:

  • To review the scientific basis and application of safety factors in establishing tolerable intake levels for chemicals.
  • To discuss the limitations of traditional methods, such as the reliance on NOAELs and the underutilization of dose-response data.
  • To explore newer approaches, like the benchmark dose, for a more refined risk assessment.

Related Experiment Videos

Main Methods:

  • Review of established methodologies used by regulatory bodies like JECFA and JMPR.
  • Analysis of the scientific rationale behind the application of safety/uncertainty factors.
  • Consideration of the impact of study design on the determination of NOAELs.
  • Exploration of alternative methods, including dose-response modeling.

Main Results:

  • The standard safety factor of 100 is commonly used to address interspecies and intraspecies variability.
  • NOAELs can be less precise due to wide dose intervals in studies and the traditional exclusion of dose-response relationships.
  • Newer methods like benchmark dose modeling offer improved utilization of dose-response data.
  • ADI values are conservative, minimizing consumer risk, but deriving tolerable intakes for environmental contaminants requires careful consideration to avoid excessive food supply loss.

Conclusions:

  • The safety factor approach, while widely used, has limitations that newer methods aim to address.
  • Accurate determination of NOAELs and effective use of dose-response data are crucial for robust risk assessment.
  • Transparent communication of the basis for tolerable intake levels is essential for informed public health decisions regarding chemical exposure.