Vitals

(주)바이탈스 Vitals

R&D

GLP flow chart

1

Preparation

  • Receive Test Item
  • Designate a Study Director
2

Study Plan

  • Prepared
  • Reviewed
  • Approved
3

Preliminary
Study

  • Gravimetric Assessment
  • Particle Size Assessment
  • Test Atmosphere Sampling
  • Test Atmosphere Analysis
4

Test

  • Animal Arrival
  • In-life (exposure) Start
  • Exposure End
  • Terminal Sacrifice Commencement
  • In-life End (final necropsy)
  • Examination
  • Hematology, Organ weights, BAL,
  • Macroscopic Pathology, Histology, etc.
5

Report

  • Prepared
  • Approved
  • Issue Final Report
6

Archive

  • Raw Data
  • Study Sample
  • Study Protocol
  • Electronic Document
  • Original Study Reports

Overview of inhalation toxicity test

1

The inhalation toxicity system aims to assess the systemic and local toxic potential of materials possibly inhaled by breathing, such as gas, dust, mist, dust, smoke, nanoparticle, etc., by exposing the materials to test animals.

2

The study can be categorized by its duration: acute toxicity, sub-acute toxicity, chronic toxicity, and it also can be classified by its exposure route: whole-body and nose-only

3

An adverse effect of a test article is assessed by applying general toxicity parameters, and if necessary, additional exams such as lung function exams and BALF biochemical exams are performed.

4

VITALS manufactures equipment for GLP inhalation toxicity study, which satisfies international standards including OECD, FDA, EPA, AAALAC, etc. Our products are used in domestic and international inhalation toxicity research. We take a leading role in this field and are now recognized as one of the best inhalation test device manufacturers.

Classification of inhalation toxicity test

Nose-only exposure test

  • Nose-only exposure to test animals by using restraint devices
  • This route minimizes test article to be exposed through other ways and minimizes the usage of test article
  • It is used for acute (1-day 4hrs) to sub-acute (28,29 days)
  • The test system includes an exposure chamber (control group, vehicle control (optional), treatment group (low, intermediate, high), generator/measurement devices, exhaust system

Whole-body exposure test

  • Expose the whole body of the test animal in an inhalation environment that is similar to a general or workplace environment
  • This route minimizes the stress of test animals
  • The scale of the whole-body exposure test is determined based on the number of animals recommended by OECD guideline
  • The size of the mental exposure test is determined according to the number of test animals that meet the OECD guidelines.
  • For Sub-chronic whole-body exposure chamber, max. Forty-eight test animals (based on the RAT standard) can be exposed simultaneously. This study includes an exposure chamber, generator/measurement equipment, and an exhaust system. For supply air, air goes through a HEPA filter.
  • For chronic whole-body exposure chamber, max. One hundred forty-four test animals (based on the RAT standard) can be exposed simultaneously. The test system includes an exposure chamber, treatment group, generator/ measurement devices, OAC and HVAC, and exhaust system.

Whole- body vs nose-only

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