Acute Systemic Toxicity Tests

Acute Systemic Toxicity Tests

Acute systemic toxicity tests are used to assess the toxicity of chemicals, medicinal products and other substances from different types of exposure. These tests are used to determine whether protective packaging, warning labels, media release guides are needed, and whether protective equipment is required.

International initiatives to use in vitro cytotoxicity testing methods to reduce animal use in the acute toxicity test were evaluated at the International In Vitro Methods Assessment Workshop on Acute Systemic Toxicity at October 2000. Following this workshop, ICCVAM recommended further evaluation of its in vitro use. Cytotoxicity data to estimate initial doses for rodent acute oral systemic toxicity studies.

To assist in the adoption and implementation of this approach, guidance on using Document as Data Estimation has been prepared by EUROLAB with the support of workshop participants starting doses for In Vivo Acute Toxicity.

EUROLAB has suggested that recent validation studies should focus on two standard basic cytotoxicity tests using human and rodent cell systems.

 To improve in vitro estimates of acute oral systemic toxicity, ICCVAM has also recommended that long-term research focus on the development of in vitro test methods:

 ⦁ Biokinetics

 Abol Metabolism

 ⦁ Organ-specific toxicity

EUROLAB and the European Center for Validation of Alternative Methods (now known as EURL ECVAM) designed an international multi-laboratory validation study to evaluate the usefulness of two proposed in vitro basal cytotoxicity tests to estimate initial doses for acute oral systemic toxicity tests.

Alternative Methods for Acute Inhalation Toxicity

NICEATM and PETA International Science Consortium (PISC) presented a series of webinars on Alternative Approaches to Acute Inhalation Poisoning to Global Regulatory and Non-Regulatory Data Requirements from March to September 2016. Webinar servers:

Review applicable regulatory guidelines to assess the potential for inhalation toxicity hazards.

Alternative approaches have been described to identify substances that may cause acute systemic toxicity by inhalation.

Acute toxicity mechanisms have been identified, which may cause significant events in adverse outcome pathways for acute inhalation toxicity. After the Webinar series, experts from industry, government, academia and non-governmental organizations discussed their experiences with alternative approaches to acute respiratory toxicity testing at NIH at September 2016 and discussed how to develop strategies adopted by regulatory agencies. Subgroups from the meeting were created to address specific actions; These groups are meeting as needed to maintain progress towards implementation.

 A summary of the webinars series and workshop: Clippinger AJ, et al. Alternative approaches to acute respiratory toxicity testing to address global regulatory and non-regulatory data requirements.

In Vitro Test Strategies for Evaluating Inhalation Toxicity of Nanomaterials

NICEATM collaborates with PISC, EPA and industry scientists to support a working group focused on inhalation toxicity. In 2014, NICEATM issued a request for information on devices and / or technologies currently used to identify potential inhalation hazards (79 FR 35176, 19 June 2014).

Subsequently, the working group met in 2015 to define the properties for the development and evaluation of an in vitro system to assess the toxicity of multi-walled carbon nanotubes during inhalation. The working group determined that the proposed in vitro system should include different lung cells co-cultured at the air-liquid interface and take into account relevant human dosimetry and nanomaterial life cycle changes. You can contact us for more information.